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The AVantage™ A/H5N1 Flu Test is intended for the in vitro qualitative detection of influenza A/H5N1 virus directly from symptomatic patient nasal or throat swab specimens or in viral cultures for the presumptive laboratory identification of influenza A/H5N1 virus. Results from testing with the AVantage™ A/H5N1 Flu Test should be used in conjunction with other laboratory testing and clinical and epidemiological risk factors for the presumptive identification of patients infected with Influenza H5N1 virus. AVantage™ A/H5N1 Flu Test is intended as a Prescription Use device. Testing should not be performed unless the patient meets the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiologic criteria for testing suspect A/H5 specimens. The definitive identification of influenza A/H5 either directly from patient specimens or from viral cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

The AVantage™ A/H5N1 Flu Test is a rapid diagnostic device that detects the presence of the H5N1 subtype from throat swabs or nose swabs collected from patients with flu symptoms, or in viral cultures for the presumptive laboratory identification of influenza H5N1 virus. It is an immunoassay, using a combination of monoclonal antibodies and recombinant proteins containing PDZ domains to capture and detect NS1. The AVantage™ A/H5N1 Flu Test begins with the extraction of the influenza A H5N1 NS1 viral antigen. The patient sample is prepared by delivering the swab to the transport medium. Sample is then transferred to the lyophilized Lysis Buffer vial (Reagent A) which contains a lysing agent where cells are lysed, releasing intracellular proteins. Next, the Loading Buffer (Reagent B) is added to condition the sample. The sample is then added to the Detector (Reagent C), which contains lyophilized colloidal gold-conjugated monoclonal anti-influenza A antibodies that recognize a broad range of influenza A subtypes and strains. After re-suspension of the antibodies, the solution is added to the sample well of the AVantage™ A/H5N1 Flu Test cassette, where NS1 in the specimen will react with reagents on the membrane of the cassette. The results are read visually by observing the presence or absence of lines on the membrane at the indicated locations.