The Food and Drug Administration has granted the reformulated BinaxNOW Influenza A & B Card 2 waived status under the Clinical Laboratory Improvements Amendments for use with Abbott’s DIGIVAL reader, which means the system is relatively simple and has a low risk of erroneous results.
According to Abbott’s press release, the DIGIVAL reader (formerly known as the Alere Reader) automatically interprets this rapid influenza diagnostic test’s results in seconds and is intended to remove subjectivity from the diagnostic process. The BinaxNOW Influenza Card A & B Card 2 is a Class II assay and complies with the FDA’s new reclassification requirements for rapid influenza diagnostic tests.