BinaxNOW® Influenza A/B Test
Simplifies rapid influenza testing. The easiest flu test on the market just got easier with accurate differentiation between influenza A and influenza B using one simple step on one test. Now you can focus on the results and treating the patient, not running the test.
The BinaxNOW Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by cell culture. This product is FDA-Cleared.
- Availability - Global
- CLIA Status - CLIA Waived and Moderately Complex
- Sample type - Nasal wash/aspirate and nasopharyngeal (NP) swabs
- Time for test results - 15 minutes
CPT CODE*: 87804QW - Influenza A immunoassay, direct optical observation.
*All CPT codes are supplied for information purposes only and represent no statement; promise or guarantee by CLIAwaivedTM Inc. that these codes will be appropriate or that reimbursement will be made. It is the responsibility of the service provider to confirm the appropriate coding required by their local Medicare carriers, fiscal intermediaries and commercial payors.
Technical Bulletin - 8/19/09
Analytical Claims Added to the BinaxNOW Influenza A/B Test
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. 2009 H1N1) and its ability to detect human infection with the 2009 H1N1 influenza virus in clinical specimens is unknown.