Abbott introduces the next generation of influenza A & B and strep a assays with fastest-ever time to molecular results

In a recent press release, Abbott (NYSE: ABT) announced 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

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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.

The Strep A 2 provides molecular detection of Group A Streptococcus bacterial nucleic acid, the primary cause of bacterial pharyngitis (sore throat), more than twice as rapidly as other available molecular tests – in six minutes or less, with call out of positive results as early as two minutes – with no culture confirmation required for negative results.

“These Influenza A & B 2 and Strep A 2 assays combine speed with efficacy for rapid delivery of molecular results, further driving value for healthcare systems where time equals money,” said Sharon Bracken, senior vice president, Rapid Diagnostics, Abbott. “By delivering fast and accurate molecular results at the point of care, these tests provide physicians with the confidence to give the right diagnosis and the ability to prescribe the right treatment earlier.”

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