Does the BinaxNOW Influenza test detect this swine flu virus?
Inverness Medical Innovations, Inc. has received clearance from the United States Food and Drug Administration (FDA) to update the analytical reactivity section of both the CLIA Waived and Moderately Complex versions of the BinaxNOW Influenza A&B Test product insert. The BinaxNOW test has been shown to detect the influenza A/California/04/2009, A/Auckland/1/2009 and A/Auckland/3/2009 (H1N1) viruses cultured from a positive human specimen. Although the test has been shown to detect these strains cultured from a positive human specimen, the performance characteristics of this device with human specimens infected with the 2009 H1N1 influenza virus have not been established. The BinaxNOW test can distinguish between influenza A and B viruses, but it does not differentiate seasonal influenza A virus from the novel influenza A (i.e.