Intended Use Package Storage Specimen Type Shelf life Time to result For the qualitative detection of SARS-CoV-2 and Influenza virus (type A and type B) antigen 20 Tests / kit 2~ 30℃ Nasopharyngeal swab 24 months from the date of manufacture 5~ 8 minutes BIOCREDIT CoviFlu Ag Duo rapid test kit www. rapigen-inc.com BIOCREDIT CoviFlu Ag Duo SARS-CoV-2 and Influenza virus (type A and type B) Antigen test » One-sample generates Three-results » Rapid Test time (5~ 8 min) » User friendly Dual Color System (Control line: Red, Test lines: Black) » Simple detection of both SARS-CoV-2 and Influenza virus (type A and type B) antigen Core Technology Black Gold Particle Dual Color System Performance Characteristics Differentiated Black Gold Conjugate Technology Black Gold Particle BIOCREDIT COVID-19 Ag RT-PCR (after symptoms occur) Total Sensitivity Specificity Positive Negative Positive 46 0 46 90.2% 100.0% Negative 5 136 141 Total 51 136 187 BIOCREDIT Influenza A&B Ag RT-PCR (after symptoms occur) Total Sensitivity Specificity A B Negative A Positive 52 0 0 52 94.5% B Positive 0 27 0 27 90.0% Negative 3 3 80 86 100.0% Total 55 30 80 165 1023_CoviFlu Ag Duo .indd 1 2020. 10. 30. �� 3:23
Transcript
Intended Use
Package
Storage
Specimen Type
Shelf life
Time to result
For the qualitative detection of SARS-CoV-2 and Influenza virus (type A and type B) antigen
20 Tests / kit
2~ 30℃
Nasopharyngeal swab
24 months from the date of manufacture
5~ 8 minutes
BIOCREDIT CoviFlu Ag Duorapid test kit
www.rapigen-inc.com
BIOCREDIT CoviFlu Ag DuoSARS-CoV-2 and Influenza virus (type A and type B) Antigen test» One-sample generates Three-results» Rapid Test time (5~ 8 min)» User friendly Dual Color System (Control line: Red, Test lines: Black)» Simple detection of both SARS-CoV-2 and Influenza virus (type A and type B) antigen
Core Technology Black Gold Particle
Dual ColorSystem
Performance Characteristics
Differentiated Black Gold Conjugate Technology
Black Gold Particle
BIOCREDIT COVID-19 Ag
RT-PCR (after symptoms occur) Total Sensitivity SpecificityPositive Negative
Positive 46 0 46
90.2% 100.0%Negative 5 136 141
Total 51 136 187
BIOCREDIT InfluenzaA&B Ag
RT-PCR (after symptoms occur) Total Sensitivity SpecificityA B Negative
A Positive 52 0 0 52 94.5%
B Positive 0 27 0 27 90.0%
Negative 3 3 80 86100.0%
Total 55 30 80 165
1023_CoviFlu Ag Duo .indd 1 2020. 10. 30. �� 3:23
SARS-CoV-2 and Influenza virus (type A and type B) antigen test BIOCREDIT CoviFlu Ag Duo www.rapigen-inc.com
➎ Insert the swab specimen and swirl he swab 5~10 times.
➏ Remove the swab while gently squeezing the head of the swab.
➐ Close the assay diluent tube with a filter cap securely.
➊ Tilt the patient's head slightly backwards
➋ Insert a nasopharyngeal swab horizontally into the nasal cavity until resistance is met at the level of the turbinate.
➌ Rotate the swab gently against the nasopharyngeal mucosa for 10 – 15 seconds.
➍ Remove the swab while making sure that the tip of the swab is wet.
Invert the assay diluent tube and gently squeeze it to draw 3~4 drops (90~150㎕) into a sample well on the device.
Read the result within 5-8 minutes.
One red line "C" within the result window.
•COVID-19 positive: Two bands appear; one red control line (C) and one black test line (T).
•Influenza A positive: Two bands appear; one red control line (C) and one black test line(A)
•Influenza B positive: Two bands appear; one red control line (C) and one black test line (B)
•Mixed infection: Red bands on the control line (C) and black bands on the multiple test lines (A,B and/or T).
No "C" line within the result window. It is recommended that the
specimen be retested.
NEGATIVE POSITIVE INVALID
X 5-10
3-4F, 16, LS-ro 91beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 14119, Republic of Korea
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