Binax Now Rapid A & B Influenza Test--CLIA waived
The 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.
NEWS--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) influenza viruses of swine lineage 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).
Intended Use
The BinaxNOW® Influenza A & B Test is an invitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens innasopharyngeal (NP) swab, nasal 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.
- Availability: Global
- CLIA status: Waived & Moderate Complexity
- Sample type: Nasopharyngeal (NP) swab, nasal swab and nasal wash/aspirate
- Flexible: test provides results while the patient waits
BinaxNOW® Influenza A & B TestingProcedure
WARNING: INVALID RESULTS can occur when too little sample is added to the test. Be sure that the lower part of the transfer pipette is full and does not have any air spaces before you add the sample to the sample pad. If there are air spaces, put the sample back in the container by squeezing the top bulb. Re-draw the sample from the bottom of the container into the pipette. Use a new pipette if needed. Remove device from the pouch just prior to testing and lay flat on work bench. Fill pipette by firmly squeezing the top bulb and then placing pipette tip into sample. Slowly release bulb while tip is still in sample. This will pull liquid into the pipette. Make sure there are no air spaces in the lower part of the pipette. See arrow on test device to find the WHITE sample pad at the top of the test strip. SLOWLY (drop by drop) add entire contents of the pipette (100 µl) to the MIDDLE of this pad such that all of the sample volume absorbs into this pad. DO NOT add sample to the pink/purple colored pad. Immediately peel off adhesive liner from the test device. Close and securely seal the device. Read result in window 15 minutes after closing the device. Note: When reading the results, tilt the device to reduce glare on the result window if necessary.
For full instructions for use, see package inserts:
About Influenza
Influenza is a highly contagious, acute, viral infection of therespiratory tract. It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus. Influenza outbreaks occur each year duringthe fall and winter months.1 Each year in the UnitedStates, about 5% to 20% of residents get influenza, and more than 200,000 people have to be hospitalized as a result ofinfluenza.2 Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually more mild.
Rapid diagnosis of influenza A and B has become more important due to the availability of effective antiviral therapy. Rapid diagnosis of influenza can lead to reduced hospital stays, antimicrobial use, and cost of hospital care.1
10 tests in box--price is for 1 box
