The Influenza A/B Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal/nasopharyngeal swabs and nasal washes/aspirates of symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. The test is not intended for the detection of influenza C viral antigen. Negative results do not preclude influenza A or B viral infection and should be confirmed via cell culture or molecular assay. The test is for professional use only.
Principle of Influenza A/B Rapid Test Device
The Influenza A/B Rapid Test Device detects influenza A and B viral antigens through visual interpretation of color development. Anti-influenza A and B antibodies to the nucleoprotein antigens are immobilized on the test region A and B of the nitrocellulose membrane, respectively. A wash/aspirate or swab sample is added to the sample extraction buffer which is optimized to extract the influenza A or B nucleoprotein antigens from specimen. During testing, the extracted antigens bind to anti-influenza A and B antibodies conjugated to colored particles on the sample pad. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by either anti-influenza A or anti-influenza B nucleoprotein monoclonal antibodies at the respective detection zone. Excess colored particles are captured at the internal control zone.