Sars-CoV-2 & RSV & Influenza A+B Antigen Combo Rapid Test
INTENDED USE
The Sars-CoV-2 & RSV & Influenza A+B Antigen Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Sars-CoV-2, Respiratory Syncytial Virus and Influenza A/B antigens in human nasopharyngeal swab specimen in individuals who are suspected of respiratory viral infection consistent with COVID-19, RSV and/or flu.
PRINCIPLE
The Sars-CoV-2 & RSV & Influenza A+B Antigen Combo Rapid Test is consist with three test strips which could be observed in the three windows of the rapid test cassette. Both of the three strips are based on sandwich method immunochromatographic assay. The nucleocapsid protein of Sars-CoV-2, generic RSV antigen, generic Influenza A antigen, and Influenza B antigen are targeted individually.
In the test strip of Sars-CoV-2, anti-SARS-CoV-2 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-SARS-CoV-2 antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another Anti-SARS-CoV-2 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region.
In the test strip of RSV, anti-RSV monoclonal antibodies are coated in the test lines and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-RSV antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the pre-coated RSV monoclonal antibodies in the test regions.
In the test strip of Influenza A+B, anti-influenza A monoclonal antibodies and anti-influenza B monoclonal antibodies are coated in the test lines and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-Influenza A&B antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the pre-coated
Influenza A & B monoclonal antibodies in the test regions.
To serve as a procedural control, a colored line will always appear at the control line regions(C) indicating that proper volume of specimen has been added and membrane wicking has occurred.
MATERIALS
Materials Provided
1) Foil pouches, each contains one test cassette, and one desiccant
bag
2) Assay buffer tubes and tips 3) Sterile swab
4) Paper tube holder 5) Instruction for use
Materials Required But Not Provided
1)Timer
TEST PROCEDURE
Allow the rapid test, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
- 1.Bring the pouch to room temperature before opening. Remove therapid test cassette from the sealed pouch and use it as soon as possible.
- 2.Place the test device on a clean and horizontal surface. Reversethe specimen collection tube, extrude 3 drops of the preparedspecimen into the specimen well (S) of the test cassette and start the timer.
See illustration below. 
- 3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS
Positive (+):
Sars-CoV-2 Positive: Both of the C line and T line appear in the left window of the rapid test cassette.
RSV Positive: Both of the C line and T line appear in the right window
of the rapid test cassette.
Influenza A Positive: Both C line and A line appear in the middle window of the rapid test cassette.
Influenza B Positive: Both C line and B line appear in the middle window of the rapid test cassette. *NOTE: The intensity of the color in the test line regions may vary
depending on the concentration of the virus present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such.
Negative (-): One colored line appears in the control line region (C). No line appears in the T line, A line, or B line region.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Relative Sensitivity: 94.44% (95%CI: 88.30%～97.93%)
Relative Specificity: >99.99% (95%CI：99.09%～100.00%)
Accuracy: 98.83% (95%CI：97.47%～99.57%)
