Seite 1
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
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5
RA
PID
SA
RS-
CO
V-2
AN
TIG
EN T
EST
CA
RD
INST
RUCT
ION
GUI
DE F
OR
ANTE
RIO
R NA
SAL
SWAB
SPE
CIM
ENS
For p
rivat
e us
e/ho
me
use/
self-
test
ing
Te
mpo
raril
y ap
prov
ed fo
r sel
f-tes
ting
acco
rdin
g to
§11
MPG
in G
erm
any
until
24.
05.2
021
(BfA
rM
GZ:
564
0-S-
007/
21) w
ithou
t com
plet
ed c
onfo
rmity
ass
essm
ent p
roce
dure
.
1N
40C5
-2
For 1
Tes
t/Box
1N40
C5-4
Fo
r 5 T
ests
/Box
1N
40C5
Fo
r 20
Test
s/Bo
x
Pl
ease
follo
w th
e in
stru
ctio
n le
afle
t car
eful
ly.
INTE
NDED
USE
R
apid
SAR
S-C
oV-2
Ant
igen
Tes
t Car
d is
an
imm
unoc
hrom
atog
raph
y ba
sed
one
step
in v
itro
test
. It i
s de
sign
ed f
or t
he r
apid
qua
litat
ive
dete
rmin
atio
n of
SAR
S-C
oV-2
viru
s an
tigen
in a
nter
ior
nasa
l sw
abs
from
in
divi
dual
s su
spec
ted
of
CO
VID
-19
with
in
the
first
se
ven
days
of
sy
mpt
om
onse
t. R
apid
SA
RS-
CoV
-2 A
ntig
en T
est C
ard
shal
l not
be
used
as
sole
bas
is to
dia
gnos
e or
exc
lude
SAR
S-C
oV-2
in
fect
ion.
SU
MM
ARY
The
nove
l cor
onav
iruse
s be
long
to t
he β
gen
us.
CO
VID
-19
is a
n ac
ute
resp
irato
ry in
fect
ious
dis
ease
. Pe
ople
are
gen
eral
ly s
usce
ptib
le. C
urre
ntly
, the
pat
ient
s in
fect
ed b
y th
e no
vel c
oron
aviru
s ar
e th
e m
ain
sour
ce o
f inf
ectio
n, a
sym
ptom
atic
infe
cted
peo
ple
can
also
be
an in
fect
ious
sou
rce.
Bas
ed o
n th
e cu
rrent
ep
idem
iolo
gica
l in
vest
igat
ion,
the
inc
ubat
ion
perio
d is
1 t
o 14
day
s, m
ostly
3 t
o 7
days
. Th
e m
ain
man
ifest
atio
ns in
clud
e fe
ver,
fatig
ue a
nd d
ry c
ough
. Nas
al c
onge
stio
n, ru
nny
nose
, sor
e th
roat
, mya
lgia
an
d di
arrh
ea a
re fo
und
in a
few
cas
es.
MAT
ERIA
LS P
ROVI
DED
Com
pone
nts
For 1
Tes
t/Box
Fo
r 5 T
ests
/Box
Fo
r 20
Test
s/Bo
x R
apid
SAR
S-C
oV-2
Ant
igen
Tes
t Car
d (s
eale
d fo
il po
uch)
1
5 20
Ster
ilized
sw
ab
1 5
20
Extra
ctio
n tu
be
1 5
20
Sam
ple
extra
ctio
n bu
ffer
1 5
20
Inst
ruct
ions
for u
se (t
his
leaf
let)
1 1
1 Tu
be s
tand
1
(pac
kagi
ng)
1 1
IMPO
RTAN
T IN
FORM
ATIO
N BE
FORE
THE
EXE
CUTI
ON
1. R
ead
this
inst
ruct
ion
guid
e ca
refu
lly.
2. D
o no
t use
the
prod
uct b
eyon
d th
e ex
pira
tion
date
. 3.
Do
not u
se th
e pr
oduc
t if t
he p
ouch
is d
amag
ed o
r the
sea
l is
brok
en.
4. S
tore
the
test
dev
ice
at 4
to 3
0°C
in th
e or
igin
al s
eale
d po
uch.
Do
Not
Fre
eze.
5.
The
pro
duct
sho
uld
be u
sed
at ro
om te
mpe
ratu
re (1
5°C
to 3
0°C
). If
the
prod
uct h
as b
een
stor
ed in
a
cool
are
a (le
ss th
an 1
5°C
), le
ave
it at
nor
mal
room
tem
pera
ture
for 3
0 m
inut
es b
efor
e us
ing.
6.
Han
dle
all s
peci
men
s as
pot
entia
lly in
fect
ious
. 7.
Ina
dequ
ate
or i
napp
ropr
iate
spe
cim
en c
olle
ctio
n, s
tora
ge,
and
trans
port
may
yie
ld i
nacc
urat
e te
st
resu
lts.
8. U
se th
e sw
abs
incl
uded
in th
e te
st k
it to
ens
ure
optim
al p
erfo
rman
ce o
f the
test
. 9.
Cor
rect
spe
cim
en c
olle
ctio
n is
the
mos
t im
porta
nt s
tep
in th
e pr
oced
ure.
Mak
e su
re to
col
lect
eno
ugh
spec
imen
mat
eria
l (na
sal s
ecre
tion)
with
the
swab
, esp
ecia
lly fo
r ant
erio
r nas
al s
ampl
ing.
10
. Blo
w th
e no
se s
ever
al ti
mes
bef
ore
colle
ctin
g sp
ecim
en.
11. T
he s
peci
men
s sh
ould
be
test
ed a
s so
on a
s po
ssib
le a
fter c
olle
ctio
n.
12. A
pply
the
drop
s of
test
spe
cim
en o
nly
to th
e sp
ecim
en w
ell (
S).
13. T
oo m
any
or to
o fe
w d
rops
of e
xtra
ctio
n so
lutio
n ca
n le
ad to
an
inva
lid o
r inc
orre
ct te
st re
sult.
14
. Chi
ldre
n un
der 1
4 ye
ars
of a
ge s
houl
d be
ass
iste
d by
an
adul
t. LI
MIT
ATIO
NS
1. T
he te
st is
to b
e us
ed e
xclu
sive
ly fo
r the
qua
litat
ive
dete
ctio
n of
SAR
S-C
oV-2
vira
l ant
igen
in a
nter
ior
nasa
l sw
ab s
peci
men
s. T
he e
xact
con
cent
ratio
n of
SAR
S-C
oV-2
vira
l ant
igen
can
not b
e de
term
ined
as
part
of th
is te
st.
2.
Pro
per
spec
imen
col
lect
ion
is c
ritic
al.
Failu
re t
o fo
llow
the
pro
cedu
re m
ay r
esul
t in
inac
cura
te t
est
resu
lts. I
mpr
oper
col
lect
ion,
sto
rage
, or e
ven
freez
ing
and
thaw
ing
of th
e sp
ecim
en c
an le
ad to
inac
cura
te
test
resu
lts.
3. If
the
vira
l loa
d of
the
spec
imen
is b
elow
the
dete
ctio
n lim
it of
the
test
, the
test
may
pro
duce
a n
egat
ive
resu
lt.
4. A
s w
ith a
ll di
agno
stic
test
s, a
def
initi
ve c
linic
al d
iagn
osis
sho
uld
not b
e ba
sed
on th
e re
sult
of a
sin
gle
test
, but
sho
uld
be m
ade
by th
e ph
ysic
ian
afte
r eva
luat
ion
of a
ll cl
inic
al a
nd la
bora
tory
resu
lts.
5. A
neg
ativ
e re
sult
does
not
exc
lude
vira
l inf
ectio
n ex
cept
for S
ARS
-CoV
-2 a
nd s
houl
d be
con
firm
ed b
y m
olec
ular
dia
gnos
tic m
etho
ds if
CO
VID
-19
is s
uspe
cted
.
6. A
pos
itive
resu
lt do
es n
ot e
xclu
de c
oinf
ectio
n w
ith o
ther
pat
hoge
ns.
7.
The
SAR
S-C
oV-2
rapi
d an
tigen
test
can
det
ect b
oth
viab
le a
nd n
on-v
iabl
e SA
RS-
CoV
-2 m
ater
ial.
The
perfo
rman
ce o
f the
SAR
SCoV
-2 r
apid
test
is d
epen
dent
on
vira
l loa
d an
d m
ay n
ot c
orre
late
with
oth
er
diag
nost
ic m
etho
ds p
erfo
rmed
on
the
sam
e sp
ecim
en.
8. U
sers
sho
uld
test
spe
cim
ens
as s
oon
as p
ossi
ble
afte
r sp
ecim
en c
olle
ctio
n an
d w
ithin
two
hour
s of
sp
ecim
en c
olle
ctio
n.
9. S
ensi
tivity
for
nas
al o
r or
opar
ynge
al s
wab
s m
ay b
e lo
wer
tha
n na
soph
aryn
geal
sw
abs.
It
is
reco
mm
ende
d to
use
the
naso
phar
ynge
al s
wab
spe
cim
ens
by h
ealth
care
pro
fess
iona
ls.
10.
Mon
oclo
nal a
ntib
odie
s m
ay fa
il to
det
ect,
or d
etec
t w
ith le
ss s
ensi
tivity
, SA
RS-
CoV
-2 v
iruse
s th
at
have
und
ergo
ne m
inor
am
ino
acid
cha
nges
in th
e ta
rget
epi
tope
regi
on.
11. T
he a
mou
nt o
f ant
igen
in a
sam
ple
may
dec
reas
e as
the
dura
tion
of il
lnes
s in
crea
ses.
Spe
cim
ens
colle
cted
afte
r day
5-7
of i
llnes
s ar
e m
ore
likel
y to
be
test
ed n
egat
ive
com
pare
d to
a R
T-PC
R a
ssay
. 12
. The
kit
was
val
idat
ed w
ith th
e as
sorte
d sw
abs.
Use
of a
ltern
ativ
e sw
abs
may
resu
lt in
fals
e ne
gativ
e re
sults
. 13
. Th
e va
lidity
of
R
apid
SA
RS-
CoV
-2
Antig
en
Test
C
ard
has
not
been
pr
oven
fo
r de
ntifi
catio
n/co
nfirm
atio
n of
tiss
ue c
ultu
re is
olat
es a
nd s
houl
d no
t be
used
in th
is c
apac
ity.
PREP
ARAT
ION
Cle
ar, c
lean
and
dry
a fl
at s
urfa
ce.
C
heck
the
test
kit
cont
ents
. Mak
e su
re th
at n
othi
ng is
dam
aged
or b
roke
n.
Tim
er a
t han
d.
Blow
you
r nos
e se
vera
l tim
es b
efor
e co
llect
ing
spec
imen
.
W
ash
hand
s.
DISP
OSA
L Th
e te
st k
it m
ay b
e di
spos
ed o
f with
nor
mal
hou
seho
ld w
aste
in a
ccor
danc
e w
ith t
he a
pplic
able
loca
l re
gula
tions
. PR
OC
EDUR
E Th
is te
st is
sui
tabl
e fo
r peo
ple
of a
ll ag
es. T
he re
com
men
ded
oper
ator
s ar
e ag
ing
from
14
to 9
0. C
hild
ren
unde
r 14
year
s of
age
sho
uld
be te
sted
by
an a
dult.
Do
not c
ontin
ue th
e te
st if
the
child
feel
s an
y pa
in.
1
Rot
ate
the
lid o
f sam
ple
extra
ctio
n bu
ffer b
ottle
. Ca
utio
n: O
pen
it aw
ay fr
om y
our f
ace
and
be c
aref
ul
not t
o sp
ill an
y of
the
liqui
d.
2
Sque
eze
all e
xtra
ctio
n bu
ffer o
ut o
f the
bot
tle in
to th
e ex
tract
ion
tube
. Ca
utio
n: A
void
touc
hing
the
bottl
e ag
ains
t the
tube
.
3
Find
the
swab
in th
e se
aled
wra
pper
in fr
ont o
f you
. Id
entif
y th
e so
ft, fa
bric
tip
of th
e sw
ab.
4
Peel
ope
n th
e sw
ab p
acka
ging
and
gen
tly ta
ke o
ut
the
swab
. Ca
utio
n: N
ever
touc
h th
e so
ft, fa
bric
tip
of th
e sw
ab
with
you
r han
ds.
5
Car
eful
ly in
sert
swab
into
one
nos
tril.
The
swab
tip
shou
ld b
e in
serte
d no
less
than
2.5
cm
(1 in
ch) f
rom
th
e ed
ge o
f the
nos
tril.
Rol
l sw
ab 3
-4 ti
mes
alo
ng th
e m
ucos
a in
side
the
nost
ril. L
eave
sw
ab in
the
nost
ril fo
r se
vera
l sec
onds
. Usi
ng th
e sa
me
swab
, rep
eat t
his
proc
ess
for t
he o
ther
nos
tril.
With
draw
sw
ab fr
om th
e na
sal c
avity
. Ca
utio
n: T
his
may
feel
unc
omfo
rtabl
e. D
o no
t ins
ert
the
swab
any
dee
per i
f you
feel
stro
ng re
sist
ance
or
pain
.
6
Plac
e sw
ab in
to e
xtra
ctio
n tu
be. R
oll s
wab
thre
e to
five
(3
-5) t
imes
. Lea
ve s
wab
in e
xtra
ctio
n bu
ffer f
or 1
m
inut
e.
7
Pinc
h ex
tract
ion
tube
with
fing
ers
and
rem
ove
the
solu
tion
from
sw
ab a
s m
uch
as p
ossi
ble.
8
Inst
all t
he n
ozzl
e ca
p on
to th
e sa
mpl
e ex
tract
ion
tube
tig
htly
.
9
Brin
g th
e ki
t com
pone
nts
to ro
om te
mpe
ratu
re b
efor
e te
stin
g. O
pen
the
pouc
h an
d re
mov
e th
e ca
rd. P
lace
th
e ca
rd o
n a
flat a
nd le
vel s
urfa
ce.
Cau
tion:
Onc
e op
ened
, the
test
car
d m
ust b
e us
ed
imm
edia
tely
.
10
Inve
rt th
e ex
tract
ion
tube
and
add
3 d
rops
(abo
ut 7
5 μL
) of t
est s
peci
men
into
the
spec
imen
wel
l (S)
by
gent
ly s
quee
zing
the
extra
ctio
n tu
be.
Cau
tion:
Th
e fo
rmat
ion
of
air
bubb
les
in
the
spec
imen
wel
l (S)
mus
t be
avoi
ded.
11
Rea
d th
e re
sults
at 1
5-20
min
utes
. C
autio
n: R
esul
ts a
fter
20 m
inut
es m
ay n
ot b
e ac
cura
te.
Dis
pose
of t
he u
sed
devi
ce a
ccor
ding
to y
our l
ocal
re
gula
tions
and
bio
haza
rd w
aste
dis
posa
l pro
toco
l. IN
TERP
RET
ATIO
N O
F RE
SULT
S
Posi
tive:
If
two
colo
red
band
s ap
pear
with
one
col
ored
ban
d in
the
Con
trol Z
one
(C)
and
anot
her i
n th
e Te
st Z
one
(T) w
ithin
15-
20 m
inut
es, t
he te
st re
sult
is
posi
tive.
C
autio
n: N
o m
atte
r how
fain
t the
col
ored
ban
d is
in th
e Te
st Z
one
(T),
the
resu
lt sh
ould
be
cons
ider
ed a
s po
sitiv
e.
Neg
ativ
e:
If on
e co
lore
d ba
nd a
ppea
rs in
the
Con
trol Z
one
(C) a
nd n
o co
lore
d ba
nd
appe
ars
in th
e Te
st Z
one
(T) w
ithin
15-
20 m
inut
es, t
he te
st re
sult
is
nega
tive.
Inva
lid:
If no
col
or li
ne a
ppea
rs in
the
cont
rol a
rea
(C) w
ithin
15-
20 m
inut
es, t
he te
st
is in
valid
. Rep
eat t
he te
st w
ith a
new
test
car
d.
QU
ALI
TY C
ONT
RO
L Th
e co
ntro
l lin
e is
an
inte
grat
ed re
agen
t and
is u
sed
to c
ontro
l the
pro
cedu
re. T
he c
ontro
l lin
e ap
pear
s w
hen
the
test
has
bee
n pe
rform
ed c
orre
ctly
and
the
reag
ents
are
reac
tive.
FR
EQU
ENTL
Y A
SKED
QU
ESTI
ON
S (F
AQ
) 1.
H
ow d
oes
the
dete
ctio
n w
ork?
Th
e N
pro
tein
of t
he S
ARS-
CoV
-2 v
irus
reac
ts w
ith t
he s
tripe
-like
coa
ting
of t
he t
est
line
and,
if
pres
ent,
resu
lts in
a c
olor
cha
nge,
i.e.
a re
d lin
e ap
pear
s. T
here
fore
, if t
he s
ampl
e do
es n
ot c
onta
in
any
vira
l pro
tein
s or
ant
igen
s, th
ere
will
be n
o re
d te
st li
ne (T
).
2.
Whe
n sh
ould
/can
I te
st m
ysel
f?
You
can
test
you
rsel
f whe
ther
you
hav
e sy
mpt
oms
or n
ot. S
tudi
es s
how
that
ear
lier t
estin
g w
ithin
th
e fir
st 4
day
s of
illn
ess
typi
cally
mea
ns a
hig
her v
iral l
oad,
whi
ch is
eas
ier t
o de
tect
. Sin
ce th
e te
st
resu
lt is
a s
naps
hot v
alid
for t
hat p
oint
in ti
me,
test
ing
shou
ld b
e re
peat
ed a
s re
com
men
ded
by lo
cal
auth
oriti
es.
3.
W
hat c
an a
ffect
my
test
resu
lt? W
hat s
houl
d I p
ay a
ttent
ion
to?
Be s
ure
to b
low
you
r nos
e m
ultip
le ti
mes
bef
ore
colle
ctin
g th
e sp
ecim
en.
Be s
ure
to v
isib
ly c
olle
ct s
ampl
e m
ater
ial (
nasa
l sec
retio
ns).
Perfo
rm th
e te
st im
med
iate
ly a
fter t
akin
g th
e sa
mpl
e.
Follo
w th
e in
stru
ctio
ns fo
r use
car
eful
ly.
Appl
y th
e dr
ops
of e
xtra
ctio
n so
lutio
n on
ly to
the
sam
ple
wel
l (S)
To
o m
any
or to
o fe
w d
rops
of e
xtra
ctio
n so
lutio
n ca
n le
ad to
an
inva
lid o
r inc
orre
ct te
st re
sult.
4.
The
test
str
ip is
cle
arly
dis
colo
red
or s
mud
ged?
Wha
t is
the
reas
on fo
r thi
s?
Plea
se n
ote
that
the
test
car
d sh
ould
not
be
used
with
mor
e th
an 3
dro
ps o
f sam
ple,
as
the
liqui
d ab
sorp
tion
of th
e te
st s
trip
is n
atur
ally
lim
ited.
If th
e co
ntro
l lin
e do
es n
ot a
ppea
r or t
he te
st s
trip
is
badl
y sm
udge
d or
dis
colo
red,
mak
ing
it un
read
able
, pl
ease
rep
eat
the
test
acc
ordi
ng t
o th
e in
stru
ctio
ns.
5.
I h
ave
take
n th
e te
st, b
ut I
don’
t see
a c
ontro
l lin
e (C
). W
hat s
houl
d I d
o?
Your
test
res
ult i
s in
valid
. Obs
erve
the
answ
er to
que
stio
n 4
and
repe
at th
e te
st a
ccor
ding
to th
e in
stru
ctio
ns fo
r use
.
6.
I am
uns
ure
abou
t rea
ding
the
resu
lt. W
hat s
houl
d I d
o?
For t
he re
sult
to b
e po
sitiv
e, 2
stra
ight
hor
izon
tal l
ines
mus
t be
clea
rly v
isib
le w
ith th
e fu
ll w
idth
of
the
cass
ette
. If y
ou a
re s
till u
nsur
e ab
out t
he re
sults
, con
tact
the
near
est h
ealth
faci
lity
acco
rdin
g to
th
e re
com
men
datio
ns o
f you
r loc
al a
utho
ritie
s.
7.
M
y re
sult
is p
ositi
ve. W
hat s
houl
d I d
o?
If yo
ur re
sult
is p
ositi
ve a
nd th
e te
st k
it th
us c
lear
ly in
dica
tes
the
cont
rol l
ine
as w
ell a
s th
e te
st li
ne,
you
shou
ld c
onta
ct th
e ne
ares
t med
ical
faci
lity
as re
com
men
ded
by y
our l
ocal
aut
horit
ies.
You
r tes
t re
sult
may
be
doub
le-c
heck
ed a
nd th
e au
thor
ity o
r fac
ility
will
expl
ain
the
appr
opria
te n
ext s
teps
.
8.
My
resu
lt is
neg
ativ
e. W
hat s
houl
d I d
o?
If th
e te
st k
it on
ly c
lear
ly s
how
s th
e co
ntro
l lin
e, th
is m
ay m
ean
that
you
are
neg
ativ
e or
that
the
vira
l lo
ad is
too
low
to
be d
etec
ted.
If
you
expe
rienc
e sy
mpt
oms
(hea
dach
e, f
ever
, m
igra
ine,
loss
of
sens
e of
sm
ell o
r tas
te, e
tc.),
ple
ase
cons
ult y
our p
rimar
y ca
re p
hysi
cian
, or t
he n
eare
st h
ealth
car
e fa
cilit
y as
reco
mm
ende
d by
you
r loc
al a
utho
ritie
s.
If yo
u ar
e no
t sur
e, y
ou c
an re
peat
the
test
. 9.
Ho
w c
an I
disp
ose
of th
e pr
oduc
t?
The
test
kit
may
be
disp
osed
of w
ith n
orm
al h
ouse
hold
was
te in
acc
orda
nce
with
the
appl
icab
le
loca
l reg
ulat
ions
.
EXPL
ANAT
ION
FOR
SYM
BOLS
In V
itro
Dia
gnos
tics
Use
See
Inst
ruct
ions
fo
r Use
Expi
ry D
ate
Test
s pe
r Kit
Keep
dry
Batc
h N
umbe
r
Auth
oriz
ed
Rep
rese
ntat
ive
Keep
aw
ay
from
sun
light
Man
ufac
ture
r
Do
not r
euse
Do
not u
se if
pa
ckag
e is
da
mag
ed
4°C
30°C
Stor
e be
twee
n 4-
30
°C
C
atal
ogue
N
umbe
r
War
ning
, ple
ase
refe
r to
the
inst
ruct
ion
Man
ufac
ture
r:
Xiam
en B
oson
Bio
tech
Co.
, Ltd
.
90-9
4 Ti
anfe
ng R
oad,
Jim
ei N
orth
Indu
stria
l Par
k,
Xiam
en, F
ujia
n, 3
6102
1, P
.R.C
hina
.
A
utho
rized
R
epre
sent
ativ
e:
Lotu
s N
L B.
V.
Koni
ngin
Jul
iana
plei
n 10
, 1e
Verd
, 259
5AA,
Th
e H
ague
, Net
herla
nds.
Dis
trib
utor
: Te
chno
med
S
ervi
ce,
Plan
ung,
H
ande
l m
it m
ediz
inis
chen
, te
chhn
isch
en
Ger
äten
und
Anl
agen
Ges
ells
chaf
t m.b
.H..
Stat
tegg
er S
traße
31B
, A-8
045
Gra
z - A
ustri
a
Su
ppor
t Hot
line
Emai
l: su
ppor
t@de
in-c
oron
a-se
lbst
test
.de
Web
: ww
w.d
ein-
coro
na-s
elbs
ttest
.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
Quelle: Beipackzettel zu den Corona-Schnelltests des Herstellers Xiamen Boson Biotech Co., Ltd.
NiedersächsischesKultusministerium
Information zur Anwendung der SelbsttestsXiamen Boson Biotech – Rapid SARS-CoV-2 Antigen Test
Anleitung Schnäuzen Sie vor der Probenentnahme mehrmals die Nase und waschen Sie sich anschließend die Hände.Extraktionsröhrchen in den Röhrchenständer der Verpackung drücken.
1. Öffnen Sie die Extraktionslösung. VORSICHT: Öffnen Sie es vom Gesicht weg und achten Sie darauf, dass Sie nichts von der Flüssigkeit verschütten.
2. Drücken Sie den gesamten Inhalt der Extraktionslösung in das Extraktionsröhrchen. VORSICHT: Vermeiden Sie den Kontakt der beiden Behälter. Achten Sie darauf, dass der Behälter nicht umfällt.
3. Finden Sie den Tupfer in der versiegelten Verpackung vor sich. Identifi zieren Sie die weiche, textile Spitze des Tupfers, die nicht mit den Händen berührt werden darf.
4. Ziehen Sie die Tupferverpackung auf und nehmen Sie den Tupfer vorsichtig heraus. VORSICHT: Versuchen Sie, die weiche, textile Spitze des Tupfers nicht mit den Händen zu berühren.
5. Führen Sie den Tupfer vorsichtig in ein Nasenloch ein. Die Tupferspitze sollte bis zu 2,5 cm tief vom Rand des Nasenlochs eingeführt werden. Drehen Sie entlang der Schleimhaut im Nasenloch, um sicherzustellen, dass sowohl Schleim als auch Zellen gesammelt werden. Drehen Sie den Tupfer 3-4 Mal. Belassen Sie den Abstrichtupfer einige Sekunden im Nasenloch. Wiederholen Sie den Vorgang mit demselben Tupfer im anderen Nasenloch. VORSICHT: Dies kann sich unangenehm anfühlen. Führen Sie den Tupfer nicht tiefer ein, wenn Sie starken Widerstand oder Schmerzen spüren.
6. Führen Sie den Abstrichtupfer mit der Probe in das Extraktionsröhrchen ein. Drehen Sie den Tupfer nun drei bis fünf (3-5) mal. Belassen Sie den Abstrich 1 Minute im Extraktionspuffer.
Stand 16.03.2021
Seite 2Quelle: Beipackzettel zu den Corona-Schnelltests des Herstellers Xiamen Boson Biotech Co., Ltd.
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
1 2 3 4 082137 / 210225
RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing
Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM
GZ: 5640-S-007/21) without completed conformity assessment procedure.
1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box
1N40C5 For 20 Tests/Box Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20
Sterilized swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain. 1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work?
The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).
2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.
3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions).
Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.
4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.
5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.
6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.
7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps.
8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test.
9. How can I dispose of the product?
The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions
for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4- 30 °C
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park,
Xiamen, Fujian, 361021, P.R.China. Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria
Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de
NiedersächsischesKultusministeriumNiedersächsischesKultusministerium
7. Drücken Sie das Extraktionsröhrchen mit den Fingern zusammen und entfernen danach so gut wie möglich die Lösung vom Abstrichtupfer, während Sie den Abstrichtupfer herausziehen und auf ein Einwegtuch legen.
8. Setzen Sie die Abdeckkappe mit Tropfaufsatz auf das Extraktionsröhrchen.
9. Öffnen Sie den Beutel und entnehmen Sie die Testkassette. Legen Sie die Testkassette auf eine fl ache und ebene Oberfl äche. VORSICHT: Nach dem Öffnen muss die Testkassette sofort verwendet werden.
10. Drehen Sie das Extraktionsröhrchen um und geben Sie 3 Tropfen (75 µl) der Testprobe auf die Probenvertiefung (S), indem Sie das Extraktionsröhrchen leicht andrücken. VORSICHT: Die Bildung von Luftblasen in der Probenvertiefung (S) ist zu vermeiden.
11. Das Ergebnis wird nach 15-20 Minuten angezeigt. VORSICHT: Nach über 20 Minuten kann das Ergebnis verfälschen.
Deutung der Testergebnisse
Positiv: Wenn innerhalb von 15-20 Minuten zwei Farblinien – eine Farblinie im Kontrollbereich (C) und eine Farblinie im Testbereich (T) – erscheinen, so ist der Test gültig und positiv. Das Ergebnis ist als positiv zu werten, egal wie schwach die Farblinie im Testbereich (T) zu sehen ist. Ein positives Ergebnis schließt eine gleichzeitige Infektion mit anderen Krankheitserregern nicht aus.
Negativ: Wenn innerhalb von 15-20 Minuten eine Farblinie im Kontrollbereich (C) erscheint, jedoch im Testbereich (T) keine Farblinie zu sehen ist, so ist der Test gültig und negativ. Ein negatives Ergebnis schließt eine virale Infektion mit SARS-CoV-2 nicht aus und sollte bei Verdacht von COVID-19 durch molekulardiagnostische Methoden bestätigt werden.
Ungültig: Wenn innerhalb von 15-20 Minuten keine Farblinie im Kontrollbereich (C) erscheint, so ist der Test ungültig. Wiederholen Sie den Test mit einer neuen Testkassette.
Seite 3
Erste-Hilfe-Maßnahmen Das Test-Kit und die Flüssigkeit enthalten chemisch reaktive Stoffe, die beim Verschütten oder Verspritzen Beeinträchtigungen der Gesundheit hervorrufen können.
Nach Hautkontakt Waschen Sie die Haut mit Wasser ab – sofern Irritationen oder Unwohlsein auftreten, konsultieren Sie einen Arzt/eine Ärztin.
Nach Augenkontakt Bei Berührung mit den Augen sofort gründlich mit viel Wasser spülen. Kontaktlinsen entfernen. Unverletztes Auge schützen. Auge weit geöffnet halten beim Spülen. Bei anhaltender Augenreizung einen Facharzt aufsuchen.
Bei Schlucken / Einnehmen Waschen Sie den Mund mit Wasser aus – sofern Irritationen oder Unwohlsein auftreten, konsultieren Sie einen Arzt/eine Ärztin.
Erste-Hilfe-Maßnahmen
Quelle: Beipackzettel zu den Corona-Schnelltests des Herstellers Xiamen Boson Biotech Co., Ltd.
NiedersächsischesKultusministeriumNiedersächsischesKultusministerium