(1)The Flu A+B Rapid Test Device is an in vitro diagnostic test for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, throat swab and nasal aspirate samples, using the rapid immunochromatographic method. The detection is based on the monoclonal antibodies specific for the nucleoprotein of either Influenza virus A or B. It is intended to aid in the rapid diagnosis of influenza A and B viral infection. Negative results should be confirmed by other methods, such as cell culture.
(1)The Flu A+B Rapid Test Device is an acute-phase screening test for qualitative detection. Sample collected may contain antigen titles below the reagent’s sensitivity threshold, so a negative test result does not exclude infection with influenza.
(2)The Flu A+B Rapid Test Device detects both viable and non-viable influenza antigens. Test performance depends on antigen loaded in the sample and may not correlate with cell culture performed on the same sample. A positive test does not rule out the possibility that other pathogens may be present. Therefore,the results must be compared with all other available clinical and laboratory information to make an accurate diagnosis.
(3)Performance of the test has not been established for monitoring antiviral treatment of influenza.