A recent press release by Abbott announced that the U.S. Food and Drug Administration has cleared its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.
Editor's Note: This article orignally appeared on Abbott's website.
Abbott announced today that the U.S. Food and Drug Administration (FDA) has cleared its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing1,2. These new assays enable the fastest-ever3 time to molecular influenza A & B and Strep A results at the point of care.4 Currently available on the ID NOW™ platform (formerly Alere i), both assays have been granted a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver. The enhanced Influenza A & B 2 assay offers the fastest point-of-care molecular detection and differentiation of influenza A and B virus available – in 13 minutes or less, with early call out of positive results in as little as five minutes – and allows for room temperature storage of all test components, simplifying and streamlining test ordering and storage. Click here to continue>>
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