Influenza A+B Antigen Combo Test
INTENDED USE
The Influenza A+B Antigen Combo Test is a rapid chromatographic immunoassay for the qualitative detection of Influenza A and Influenza B antigens in human nasopharyngeal swab, or oropharyngeal swab specimen in individuals who are suspected of respiratory viral infection consistent with flu symptoms.
MATERIALS
Materials Provided
1) Foil pouches, each contains one test cassette, and one desiccant bag
2) Assay buffer tubes (0.5ml each) and tips
3) Disposable Sampling Swabs
4) Paper tube holder
5) Instruction for use
Materials Required But Not Provided
1)Timer
PRINCIPLE
The Influenza A+B Antigen Combo Test is consist with one test strips which could be observed in the window of the rapid test cassette. The strip is based on sandwich method immunochromatographic assay. The generic Influenza A antigen, and Influenza B antigen are targeted individually.
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.
PERFORMANCE CHARACTERISTICS
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Sensitivity, Specificity and Accuracy
The Influenza A+B Antigen Combo Test has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity
1)Influenza A part
Relative Sensitivity: 93.75% (95%CI: 89.04%～96.59%)
Relative Specificity: >99.99% (95%CI：98.78%～100.00%)
Accuracy: 98.01% (95%CI：96.42%～98.93%)
2) Influenza B part
Relative Sensitivity: 92.65% (95%CI: 83.54%～97.19%)
Relative Specificity: >99.99% (95%CI：99.04%～100.00%)
Accuracy: 99.09% (95%CI：97.82%～99.67%)
INTERPRETATION OF RESULTS
Positive (+):
Influenza A Positive: Both C line and A line appear in the window of the rapid test cassette.
Influenza B Positive: Both C line and B line appear in the 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.
1)Influenza A part
Relative Sensitivity: 93.75% (95%CI: 89.04%～96.59%)
Relative Specificity: >99.99% (95%CI：98.78%～100.00%)
Accuracy: 98.01% (95%CI：96.42%～98.93%)
2) Influenza B part
Relative Sensitivity: 92.65% (95%CI: 83.54%～97.19%)
Relative Specificity: >99.99% (95%CI：99.04%～100.00%)
Accuracy: 99.09% (95%CI：97.82%～99.67%)
INTERPRETATION OF RESULTS
Positive (+):
Influenza A Positive: Both C line and A line appear in the window of the rapid test cassette.
Influenza B Positive: Both C line and B line appear in the 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.