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HEALTH

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CARDIAC M

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RAPID . EASY . ACCURATE

JOIN

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NOVATIVE IN

VENTION!

FOR B

ETTER HEALTH &

WELLNESS!

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WHO WE ARE The 1st Saudi Factory for rapid tests in Saudi Arabia

and the Middle East Promoting and introducing new and safety innovation in health care environment.We offer a

wide range of innovative diagnostic products that provides rapid discovering and diagnosis of different diseases under

the name of NATEJAH.

IMAGE ILLUSTRATIONFocusing on best quality and high standard medical products& working to-wards making healthy, hygienic, Safe Medical Practices, and Hospital Services. We are creating awareness about the importance of using right products that are safe for daily use in health services.We are committed to making the whole region of GCC & Middle East a healthy living condition, by providing high standard and better quality products.

VISIONReaching the set Goals where sky is the limit covering the whole network ofGCC & Middle East in supplying all our products, to be there, be committed, Stay focus, adapting to the legalities and meeting all the challenges with dedi-cation, hard work and commitment.

MISSIONRealizing our vision with well-planned strategies, being competitive in prices,efficient in service, regular follow up, monitoring business growth and market progress regularly, maintaining quality, keeping the whole region in focus at all times to keep the competition at bay, all efforts will be made to block competi-tion with full study of their products.We got the Team, Network and the stuff it takes to deliver our products.

QUALITY MANAGEMENTOur company is certified in accordance with (ISO 13485:2016) IAS accredited,C-GMP certified and DUV certification PVT.LTD.Registered Trade Mark at Ministry of CommerceOur Quality Management system is being continuously improved and updated.

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Product Name Catalog No. Format Specimen SensitivityNATEJAH One Step HCG Rapid Test LA01-1001

Cassette Serum/Urine 20 mIU/ml

NATEJAH One Step HCG Rapid Test LA01-10010Cassette

Urine 20 mIU/ml

NATEJAH One Step HCG Rapid Test LA01-10011Midstream

Urine 10 mIU/ml

NATEJAH One Step Luteinizing Hormone (LH) Test Kit

LA10-1001Midstream

Urine 30mlU/ml

NATEJAH One Step Hepatitis B Surface Antigen (HBsAg) Rapid Test

LA04-2004Cassette

Serum/Plasma 1 ng/ml


LA04-20041Cassette Serum/Plasma

/Whole Blood1 ng/ml

NATEJAH One Step Hepatitis C Virus (HCV) Antibody Test

LA04-2003 Cassette

Serum/Plasma >99%


LA04-20031Cassette Serum/Plasma

/Whole Blood>99%

NATEJAH One Step HIV-Ab/Ag 4th Gen Rapid Test

LA04-20022Cassette Serum/Plasma/

Whole Blood100%

NATEJAH One Step Human Immunodeficiency Virus ½ (HIV1/2) Antibody Test

LA04-2002Cassette

Serum/Plasma >99%

NATEJAH One Step Human Immunodeficiency Virus ½ (HIV1/2) Antibody Test

LA04-20021Cassette Serum/Plasma/

Whole Blood>99%

NATEJAH One Step Treponema Pallidum Antibody Rapid Test

LA04-1006 Cassette Serum/plasma/

whole Blood>95%

NATEJAH One Step Helicobacter Pylori Antibody Rapid Test

LA02-1002Cassette

Serum/Plasma

NATEJAH One Step Helicobacter pylori Antigen Rapid Test

LA02-1003Cassette

Fecal Sample

NATEJAH One Step Malaria (pf) Rapid Test LA07-1009Cassette

Whole Blood 50 Parasites

NATEJAH One Step Malaria (pf/pan) Rapid Test LA07-1011Cassette


NATEJAH One Step Malaria (pf/pv) Rapid Test LA07-1010Cassette


NATEJAH One Step Dengue Combo Rapid Test (IgG/IgM Antibody)

LA03-1004 Cassette Serum/Plasma/

Whole Blood

NATEJAH One Step Dengue NS1 Antigen Test LA03-1005Cassette

Serum/Plasma

NATEJAH One Step Fecal Occult Blood Rapid Test

LA06-1008Cassette

Fecal Sample >98%

NATEJAH One Step Troponin I (cTnI) Rapid Test LA05-1008Cassette Serum/Plasma/

Whole blood100%

NATEJAH One Step Troponin I (cTnI) Rapid Test LA05-1007Cassette

Serum/Plasma 100%

NATEJAH One Step Vitamin D Rapid Test(single Test)

LA08-1002Cassette Serum/Whole

Blood80 ± 15 nmol/L

(99%)

NATEJAH One Step Vitamin D Rapid Test LA08-1001Cassette Serum/Whole

Blood80 ± 15 nmol/L

(99%)

NATEJAH One Step Urinalysis Reagent Strips (11 Parameters)

LA11-1001 Strip Urine

Natejah HemotypeSC TMRapid Test LA12-1001 Strip Whole blood 100%

NATEJAH RAPID DIAGNOSTIC TEST PRODUCT LIST

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LA01-1001

LA01-10010

LA01-10011

NATEJAH One Step HCG Rapid Test (Urine )( Cassette)

NATEJAH One Step HCG Rapid Test( Ultra Sensitive for early detection )

(Urine ) ( mid stream )NATEJAH One Step HCG Rapid Test

( Serum & Plasma ) (Cassette)

The test provides a visual, qualitative result that helps in the early diagnosis of pregnancy

Intended Use

Sensitivity: 100% Specificity: 99.42%

RAPID: RESULT

UP TO 10 MINUTES

EASY:SIMPLE USAGE TO

MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

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Remove the testing device from the sealed pouch by tearing at the notch and place the test-ing device on a leveled surface.

DO NOT INTERPRET RESULTS AFTER 30 MINUTES

Urine samples Serum samples Plasma samples

Any urine specimen is appropriate for HCG testing. However, urine specimens collected early in the morning are mostly recommended.

Collect blood in a tube without anticoagulant and allow it to clot

Collect blood in a tube containing anticoagulant

Cassette Midstream

• Hold the sample dropper vertically and add three full drops of speci-men without air bubbles into the sample well that is marked with an arrow on the testing device .

• Read the results after 10 minutes• Strong positive specimens may

produce positive result in as little as 1 minute

• Confirm negative results in 10-20 minutes.

• Uncap the device. • Point the absorbent tip down-

ward. Place the absorbent tip in urine stream for about 5 seconds.

• Re-cap the device. • Wait for colored bands to appear

and read results. • Positive results can be read as

soon as it appears.• Confirm negative results in 5 to

10 minutes

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LA01-10010 NATEJAH One Step Luteinizing Hormone (LH) Test Kit

(Urine)

Intended Use This test provides qualitative detection of LH in urine at or above the concen-tration of 30 mIU /ml and predicting the time of LH surge and ovulation. The device is designed for professional and over the counter use.

RAPID: RESULT IN 10 MINUTES


MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

LA10-1001

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When to begin testingThe test can be done at any time of the day, preferably after 10:00 am and be-fore 8:00 pm. If tested twice a day, test at least 8 hours apart to help catch shorter LH surges. Testing should be done at approximately the same time each day. Reduce liquid intake for 2 hours before testing. To find out on what day to begin testing, determine the length of your normal period cycle. The length of one cycle is from the beginning of one period (the day of first bleeding) to the day before the beginning of the next cycle. The first day of bleeding or spotting is counted as day one (1). If the cycle length is irregular, that is, if it varies by more than a few days each month, take the average number of days for the last 3 months.

Test procedure• Remove the testing device from the sealed, pouch

by tearing at the notch • Uncap the device. • Point the absorbent tip downward in urine stream

for about 5 seconds to wet it thoroughly, or collect the urine in a clean cup and dip half of the absor-bent pad into the urine for at least 5 seconds until the urine sample move into test window.

• Re-cap the device. • Read the result in 10 minutes.

NOTE:Strong positive specimens may produce positive results in as little time as 1 minute. Confirm negatives in 10-20 minutes. DO NOT INTERPRET RESULTS AFTER 30 MINUTES.

Length of Normal Cycle (Total days)

21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40

Start testing ___ days after your last period

began.5 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

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NATEJAH One Step Vitamin D Rapid Test (Serum/Whole Blood)

Intended Use The test provides a qualitative detection of Vitamin D levels in human blood/serum

Sensitivity: 99% Specificity: 96%



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

LA08-1001

9

Test Procedure

1. Remove the cassette from sealed pouch and place it on a hard flat surface with the view window facing up.

2. Add 10 µl of whole blood using blood pipette provided or 5ul of serum sample using micropipette into the rectangular specimen well (marked with red drop) of the cassette.

3. Add 3 full drops of Chase Buffer into the square buffer well of the cassette (Do not move the cassette after addition of buffer).

4. Let cassette sit for 10 minutes and read your results imme-diately. Results may deteriorate after the 10 minute mark.

• A dark test line indicates that the sample (blood or serum) is deficient in Vitamin D (less than 80 nmol/L).

• whereas a faint test line (or no test line) indicates the sample has sufficient Vitamin D (more than 80 nmol/L).

• If the control line does not appear after 10 min, the test is not valid.

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LA10-1001 NATEJAH One Step Urinalysis Reagent Strips (11 Parameters)

Intended Use This test provides a dip-and-read reagent strips for in-vitro diagnostic testing.It is measured by comparison of test paper attached to a plastic strip with the color chart blocks printed on the vial labels.The strips may be read visually or instrumentally, using urine chemistry analyzers.The test is for the detection of one or more of the following analytes in urine:Leukocytes, Glucose, Ketone (Acetoacetic acid), Bilirubin,Blood, Specific Gravity, Protein, Urobilinogen, Nitrite, Ascorbic acid and, pH.



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

Check the Status of Carbohydrate metabolism

Glucose found in urine suggests glycosuria, which is commonly due to untreated diabetes.Kidney & Liver Function Protein found in urine suggests possible proteinuria, which is commonly caused by diseases that have secondarily affected the kidneys. Bilirubin found in high levels in the urine suggests bilirubinuria, which might indicate possible liver damageAcid-Base Balance Ketones present in urine sug-gest ketonuria, which is commonly due to untreat-ed diabetes.Urinary Tract Infection High levels of nitrate found in urine indicate the presence of coliform bacteria, which suggests possible urinary tract infection.

LA11-1001

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Recommendations:• Use fresh morning urine.• Skin cleansers containing chlorhexidine may affect protein test results.• Test immediately after collecting.• If unable to test immediately, store in the fridge, do not freeze.• Bring to room temperature before testing.• Unpreserved urine at room temperature may undergo pH changes, which may

interfere with protein determination

Test procedure• Collect urine in a clean container and dip the strip for no more than 2 seconds.• Remove excess urine by drawing the edge of the strip along the wall of the con-

tainer without touching the test areas of the strip. • Tap the side of the strip on a paper towel to absorb excess urine.• Hold the strip horizontally and compare the colors of the reagent pads against the

color chart in the vial after exactly 60 seconds (or 120 seconds for leukocytes).

NOTE:Note: Results may be read up to 2 minutes after the specified times.

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LA08-1002

Sensitivity: 99.82% Specificity: 99.89%

Intended Use This test provides qualitative detection of HBsAg in human whole blood, se-rum or plasma samples at or above a level of 1 ng/ml. It is intended for professional use as an aid in the diagnosis of Hepatitis B virus (HBV) infection.


(Serum/Plasma/Whole blood)

NATEJAH One Step Hepatitis B Surface Antigen(HBsAg) Rapid Test

(Serum/Plasma)



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

LA10-1001

LA10-1001LA04-2004

LA04-20041

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Test Procedure• Blood samples may be collected by finger stick or

venipuncture • For Whole blood samples collect blood in a tube

containing anticoagulant& should be tested imme-diately after sample collection.

• For Serum samples collect blood in a tube without anticoagulant and allow it to clot.

• For Plasma samples collect blood in a tube containing anticoagulant.• Remove the testing device from the sealed pouch by tearing at the notch

and place the testing device on a leveled surface.

Serum/Plasma/WholeBlood samples serum /plasma samples

• Hold the sample dropper vertically and add one drop of specimen without air bubbles into the sam-ple well that is marked with an arrow on the testing device.

• Wait for 20-30 sec, then add 2 drops of the assay buffer to the sample well of the testing device.

• Read the results in 10-30 minutes• NOTE: Specimens with high concentrations of

HBs Ag may produce positive result in as little as 1 minute.

• Confirm negatives in 20-30 minutes.• DO NOT INTERPRET RESULTS AFTER 40 MIN-

UTES

• Hold the sample dropper vertically and add three full drops of speci-men without air bubbles into the sample well that is marked with an arrow on the testing device.

• Read the results after 10 minutes.• NOTE: Specimens with high

concentrations of HBs Ag may produce positive results in as little as 1 minute.

• Confirm negatives in 20 minutes. • DO NOT INTERPRET RESULTS

AFTER 30 MINUTES

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// NATEJAH One Step Hepatitis C Virus (HCV) Antibody Test

(Serum/Plasma/Whole blood)


(Serum/Plasma)

Intended Use This test provides a qualitative detection of HCV Antibodies in human Whole blood, serum or plasma samples. It is intended for professional use as an aid in the diagnosis of Hepatitis C virus infection.

Sensitivity: 99.76 % Specificity: 99.59%



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

LA08-1002LA10-1001

LA10-1001LA04-2003

LA04-20031

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venipuncture • For Whole blood samples collect blood in a tube

containing anticoagulant& should be tested imme-diately after sample collection.




Serum/Plasma/Whole Blood samples serum /plasma samples



• Read the results after 10 minutes• NOTE: Specimens with high concentrations of HCV

Antibodies may produce positive result in as little as 1 minute.


UTES


• Read the results after 10 minutes.• NOTE: Strong positive Specimens

may produce positive results in as little as 1 minute.

• Confirm negatives in 10: 20 minutes.

• DO NOT INTERPRET RESULTS AFTER 30 MINUTES

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NATEJAH One Step HIV-Ab/Ag 4th Gen Rapid Test

(Serum/Plasma/Whole Blood)

Intended Use This test provides a qualitative detection of antibodies (IgG, IgM, IgA) to an-ti-HIV-1 (including O) &HIV-2 virus and HIV-1 p24 antigen in human serum, plasma or whole blood. It is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with HIV.


RAPID: RESULT IN 15MINUTES


MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

LA04-20022

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Interpretation of results


venipuncture. • For Whole blood samples collect blood in a tube con-

taining anticoagulant or it can be used directly without anticoagulant. & it should be tested immediately after sample collection.


• For Plasma samples collect blood in a tube containing anticoagulant.

• Remove the testing device from the sealed pouch by tearing at the notch and place the test-ing device on a leveled

• surface.• Hold the sample dropper vertically and add one drop of specimen without air bubbles into

the center of the sample well.• Immediately add 2 drops (about 60-80 µL) of Sample Diluent to the sample well with bottle

positioned vertically• Results should be read in 15 minutes.• Do not interpret results after 20 minutes.• To avoid confusion, discard the test device after interpreting the result

Negative result HIV 1+2 Ab positive

result

HIV p24 antigen positive

result

HIV 1+2 Ab and p24 an-tige positive

INVALID

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NATEJAH One Step Human Immunodeficiency Virus 1/2 (HIV 1/2) Antibody Rapid Test

serum/plasma/whole blood NATEJAH One Step Human Immunodeficiency

Virus 1/2 (HIV 1/2) Antibody Rapid Test

(Serum/Plasma)

Intended Use This test provides a qualitative detection of antibodies against HIV type 1 and type 2 in human Whole blood, serum or plasma samples. It is intended for professional use as an aid in diagnosis of HIV infections.




MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE


//LA08-1002LA10-1001

LA10-1001LA04-2002

LA04-20021

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Test Procedure

• Blood samples may be collected by finger stick or venipuncture

• For Whole blood samples collect blood in a tube containing anticoagulant& should be tested imme-diately after sample collection.







• Read the results in 10-30 minutes• NOTE: Specimens with high concentrations of HIV

Antibodies may produce positive result in as little as 1 minute.


UTES



may produce positive results in as little as 1 minute.



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NATEJAH One Step Treponema pallidum Antibody (TP) Rapid Test(Serum/plasma/whole Blood)

Intended Use This test provides qualitative detection of antibodies against Treponema pall-idum in human serum or plasma samples. It is intended for professional use as an aid in diagnosis of syphilis.




MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

Sensitivity: 95.7% Specificity: 98%

LA10-1001LA04-1006

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• For Plasma samples collect blood in a tube contain-ing anticoagulant.

• Remove the testing device from the sealed pouch by tearing at the notch and place the testing device on a leveled surface.

• Hold the sample dropper vertically and add three full drops of specimen without air bubbles into the sample well that is marked with an arrow on the testing device.

• Read the results after 10 minutes.• NOTE: Strong positive Specimens may produce positive results in as

little as 1 minute.• Confirm negatives in 10: 20 minutes. • DO NOT INTERPRET RESULTS AFTER 30 MINUTES

Test Procedure

22

NATEJAH One Step Helicobacter pylori Antibody RapidTest

(Hp) (Serum/Plasma)

Intended Use This test provides qualitative detection of H. pylori antibody in human serum or plasma samples. It is intended for professional use to aid in the diagnosis of peptic ulcers, gastri-tis, duodenitis, extradigestive diseases and in some cases, cancer.



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

Sensitivity: 93.9% Specificity: 96%

LA10-1001LA02-1002

23



• For Plasma samples collect blood in a tube con-taining anticoagulant.


• Hold the sample dropper vertically and add three full drops of specimen without air bubbles into the sample well that is marked with an arrow on the testing device.

• Read the results after 10 minutes.• NOTE Specimens with high concentrations of H. pylori antibodies may

produce positive results in as little as 1 minute. Confirm negatives in 20 minutes.

• DO NOT INTERPRET RESULTS AFTER 30 MINUTEs

Test Procedure

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NATEJAH One Step Helicobacter pylori Antigen RapidTest (Hp Ag)

(Fecal)

Intended Use This test provides qualitative detection of Helicobacter pylori (H. pylori) anti-gen in human fecal samples or a biopsy of a mucosa sample from the stomach lining. It is intended for professional use to aid in the diagnosis of H. pylori infection in patients with gastrointestinal symptoms.



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

LA02-1003

25

Biopsy Samples Fecal samples

1 .Collect biopsy of mucosa samples from the stomach lining.2. Unscrew the cap of the specimen collection tube and take out the specimen collection stick;3. Put the biopsy sample to the specimen collection tube;

• Use clean, dry containers for specimen collection. Best results will be obtained if the assay is performed within 6 hours after collection.

• Unscrew the cap of the specimen collection tube and take out specimen collection stick.

3. For Solid SpecimenStab the specimen collection stick into the fecal specimen in at least 3 differ-ent sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.For Liquid SpecimenHold the pipette vertically, aspirate fecal specimens, and then transfer 6 drops into the specimen collection tube containing the extraction buffer.

Test Procedure

4. Insert the specimen collection stick into the tube and tighten the cap. 5. Shake the tube vigorously to ensure thorough mixture of the specimen and the assay diluents reagent.6. Remove the test cassette from the sealed pouch and use it as soon as possible. Caution: Do not touch the test window and the membrane inside.7.For Biopsy and Fecal samples prepared above- a.) Hold the specimen collection tube upright and break off the tip with hands. b.) Invert the vial and add 3 full drops of specimen without air bubbles into the sample well of the cassette.8. Read the results within 15 minutes.Note: Strong positive specimens may produce positive results in as little as 1 minute. Confirm nega-tives in 15-30 minutes.DO NOT INTERPRET RESULTS AFTER 30 MINUTES.Note: • Best results will be obtained if the assay is performed right after collecting fecal samples. • Specimens prepared in the specimen collection tube may be stored for six months at -20°C if not

tested within 1 hour after preparation.

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NATEJAH One Step Malaria (pf) Rapid Test (Whole Blood)

NATEJAH One Step Malaria (pf/pan) Rapid Test (Whole Blood)

NATEJAH One Step Malaria (pf/pv) Rapid Test (Whole Blood)



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

Sensitivity: 98.8% Specificity: 97.6% (for daignosis of pf infection) Sensitivity: 94.6% Specificity: 97.6% (for daignosis of pv&pan infection)

LA07-1009

LA07-1011

LA07-1010

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NATEJAH One Step Malaria (pf) Rapid Test

NATEJAH One Step Malaria (pf/pan) Rapid Test

NATEJAH One Step Malaria (pf/pv) Rapid Test

This test provides qualitative detection of Plasmodium falci-parum specific histi-dine-rich protein II (Pf HRP-II) in whole blood samples. It is intended for professional use as an aid in the diagnosis of malarial infection.

This test provides qualitative detection of Plasmodium antigens circulating in the human venous and capillary systems with signs and symptoms of malarial infection. The test targets the histi-dine-rich protein II (HRPII) antigen spe-cific to Plasmodium falciparum (P.f.) and a pan-malarial antigen, common to all four malaria species capable of infecting humans - P. falciparum, P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.). It is intended to aid in the rapid diag-nosis of human malaria infections and to aid in the differential diagnosis of Plasmodium falciparum infections from other less virulent malarial infections.

This test provides qualitative detection of Plasmodium falci-parum (P.f) and Plas-modium vivax (P.v) in whole blood samples. It is intended to aid in the rapid diagnosis of human malaria infec-tions and to aid in the differential diagnosis of Plasmodium falci-parum infections from Plasmodium vivax infections.

• Samples should be collected by a fingerstick or venipuncture according to standard methods.

• Whole blood samples should be used immediately.• Remove the testing device from the sealed pouch by tearing at the notch. Place the test-

ing device on a level surface.• Add 5 µl blood sample with a pipette to the sample well (close to the test window) of the

test device (hold the pipette vertically and gently touch the end against the pad within the sample well for transferring).

• Immediately add four drops of the buffer to the buffer well (close to bottom) of the test-ing device.

• Read the results in 20-30 minutes.. • DO NOT INTERPRET RESULTS AFTER 45 MINUTES.

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NATEJAH One Step Dengue Combo Rapid Test (IgG/IgM Antibody)

(Serum/Plasma/Whole Blood)



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE


Sensitivity: 91% Specificity: 92.7 %

NATEJAH One Step Dengue NS1 Antigen Rapid Test

(Serum/Plasma)

LA03-1004

LA03-1005

29

NATEJAH One Step Dengue Combo Rapid Test (IgG/IgM Antibody)(Serum/Plasma/Whole Blood)

NATEJAH One Step Dengue NS1 Antigen Rapid Test (serum/plasma)

This test provides qualitative differential detection of IgG & IgM antibodies to dengue virus 1-4 serotypes in human serum, plasma and/or whole blood samples. It is intended for professional use to diagnose Den-gue virus infections and help to differentiate be-tween a primary and secondary dengue infection.

This test provides qualitative de-tection of Dengue NS1 antigen in human serum or plasma samples. It is intended for professional use as an aid in the diagnosis of Dengue virus infections.

• Blood samples may be collected by finger stick or venipuncture. • For serum samples, collect blood in a tube without anticoagulant and allow it to clot.• For plasma samples, collect blood in a tube containing anticoagulant.• Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only

clear, non-hemolyzed specimens. • For whole blood samples, collect blood in a tube containing anticoagulant. • Whole blood samples should be tested immediately after sample collection. • Remove the testing device from the sealed pouch by tearing at the notch and place the

testing device on a leveled surface.

• Add 5 µl sample with pipette to upper area (close to test window) of sample well of the test device (hold the pipette vertically and gently touch the end against the pad within the sample well for transfer-ring).

• Immediately add 2 drops of buffer to the same sample well of the testing device.

• Read the results in 10 minutes. • NOTE: Strong positive specimens may produce

positive result in as little as 1 minute and confirm negative results in 20 minutes.

• DO NOT INTERPRET RESULTS AFTER 30 MIN-UTES.

• Hold the sample dropper vertical-ly. Add 3 full drops of the speci-men without air bubbles into the sample well that is marked with an arrow on the testing device.

• Read the result in 10-30 minutes.• NOTE: Strong positive specimens

may produce positive result in as little as 1 minute. Confirm nega-tives in 10-20 minutes.


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NATEJAH One Step Fecal Occult Blood Rapid Test

(Fecal Sample)

Intended Use This test provides qualitative detection of hemoglobin in human fecal samples.It is intended for professional use as an aid in the diagnosis of colon polyps, colorectal carcinoma, ulcerative colitis and Crohn’s disease



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

Sensitivity:98.1 % Specificity: 99.7 %

LA06-1008

31

Specimens with high concentrations of FOB may produce positive results in as lit-tle as 1 minute and confirm negative results in 15-30 minutes. DO NOT INTERPRET RESULTS AFTER 30 MINUTES

NOTE:Best results will be obtained if the assay is performed within 6 hours after collecting fecal samples. The collected specimen may be stored for 3 days at 2-8°C if not tested within 6 hours. Specimens prepared in the specimen collection tube may be stored for 3 days at room temperature (2-8°C) if not tested within 1 hour after preparation

• Use clean, dry container for specimen collection. • Unscrew the cap of the specimen collection tube and take out specimen

collection stick.• Stab the specimen collection stick into the fecal specimen in at least 3

different sites of the feces. Do not scoop the fecal specimen.• Insert the specimen collection stick into the tube and tighten the cap. • Shake the tube vigorously to ensure thorough mixture of the specimen

and the assay diluents reagent.• Remove the test cassette from the sealed pouch and use it as soon as

possible.• Caution: Do not touch the test window and the membrane inside• . A) Hold the specimen collection tube upright and break off the tip with

hands. • . B) Invert the vial and add 3 full drops of specimen without air bubbles

into the sample well of the cassette.• Read the results within 15 minutes.

Test Procedure

32

NATEJAH One Step Troponin I (cTNI) Rapid Test (Serum/Plasma)

NATEJAH One Step Troponin I (cTNI) Rapid Test (Serum/Plasma/Whole blood)

Intended Use This test provides qualitative detection of human cTnI at or above the cut off level of 1 ng/ml in humen serum and plasma samples and/or whole blood samples. It is intended for professional use as an aid in the diagnosis of acute myocardial infarction (AMI).



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

Sensitivity:100 % Specificity: 98.06%

LA05-1008

LA05-1007

33



• For Plasma samples collect blood in a tube con-taining anticoagulant.

• For whole blood samples, collect blood in a tube containing anticoagulant.


Test Procedure




• Read the results after 10 minutes• NOTE: Specimens with high concentrations of cTnI

may produce positive result in as little as 1 minute.• Confirm negatives in 10-20 minutes.• DO NOT INTERPRET RESULTS AFTER 30 MIN-

UTES



may produce positive results in as little as 1 minute



34

Natejah HemotypeSCRapid Test



MINIMIZE USER ERROR

ACCURATE:HIGHLY

SENSITIVE

LA12-1001

35

Test procedure

Observe applicable biohazard safety procedures when handling Test Strips and human blood. Do not reuse any test strips or blood sampling devices. Some immobilized Test Strip reagents are derived from human sources - refer to local and national guidelines for biohazard safety handling procedures.

Intended Use This Test is a rapid test kit for the determination of hemoglobin type in whole blood. This test provides point- of- care detection of hemoglobin phenotypes HbAA(normal), HbSS and HbSC(sickle cell disease), HbCC(hemoglobin dis-ease),and HbAS and HbAC (carrier or trait).

1-Using Dropper Pipette, add six (6) drops of water to Test Vial, Place Test Vial in a compatible rack.

2-Open Vial of Blood Sampling Devices, remove one Blood Sampling Device, and reclose Vial.

Obtain blood sample – a small drop is sufficient (1 to 2 microliters). Touch the white pad of the Blood Sampling Device to blood sample, until the

white pad absorbs the blood droplet. Ensure that the entire white pad has turned red.

3-Insert Blood Sampling Device into Test Vial water and swirl to mix.a. Sufficient swirling is essential for blood to be properly transferred into Test Vial.b. Check visually to ensure that water has become pink or light-red in color. c. Leave Blood Sampling Device in the Test Vial after swirling.

4-Open Vial of Test Strips, remove one Test Strip, and reclose Vial. Insert HemoTypeSCTM Test Strip into Test Vial with arrows pointing down.

5-Wait 10 minutes.6-Take HemoTypeSCTM Test Strip out of the Test Vial and read results.

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READING RESULTS:

Red lines may appear at each of three hemoglobin variant- specific locations (HbA, HbS, & HbC), and a control location.

Compare the HemoTypeSCTM Test Strip to the Results Chart below

[Absent Line(s) = Hemoglobin(s) Are Present in the Blood] [If control line is absent, result is invalid]

IMPORTANT: If test result is unclear or invalid, repeat the entire procedure starting with Step 1#.

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مصنع لانا الخليج الاول للمستلزمات الطبيةالمدينة الصناعية الثانية بجدة

مجمع 2 الوحدة 9

Lana Al Khaleej Al Awal Factory for Medical Supplies,Jeddah Second industrial City,

Block-2, Unit-9

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