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Abbott Gets CLIA Waiver for Reformulated Rapid Influenza Test With Diagnostic Reader

NEW YORK (360Dx) – Abbott said today that the US Food and Drug Administration has granted a CLIA waiver for use of its reformulated rapid influenza diagnostic test, BinaxNOW Influenza A & B Card 2, with the firm's Digival diagnostic reader for the rapid detection of influenza virus.

BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay used for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. 

The Digival reader, formerly called the Alere reader, reads and interprets BinaxNOW Influenza A & B Card 2 tests in seconds, delivering automated results in a broad range of healthcare settings, Abbott said.

The combined platform is available throughout the US for use in hospital laboratories, emergency rooms, physician offices, walk-in clinics, and urgent care centers.

Abbott's Senior Vice President of Rapid Diagnostics Sharon Bracken said in a statement that the BinaxNOW Influenza A & B Card 2 adds to its "strong portfolio of rapid flu tests by providing rapid and easy diagnosis, while Digival enhances healthcare providers' confidence in results by reducing user subjectivity."