FDA clears Abbott’s Influenza A & B 2, Strep A 2 assays


The Food and Drug Administration has cleared Abbott Laboratories’ next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.

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The Influenza A & B 2 assay can detect and differentiate influenza A and B in 13 minutes, with a call-out of positive results at 5 minutes. It can be stored at room temperature, simplifying storage and ordering. The Strep A 2 assay detects group A streptococcus bacterial nucleic acid in 6 minutes, with a call-out of positive results at 2 minutes. Both will be the fastest tests currently on the market in their respective fields, according to a corporate press release.

The assays will be available in a variety of inpatient and outpatient settings, particularly in locations where patients commonly access health care services, such as EDs, physician offices, walk-in clinics, and urgent care centers. This will allow health care providers to make a fast, informed diagnosis and provide appropriate treatment within the span of a single patient visit.

“The ability to obtain early call outs for positive test results with molecular accuracy in as little as 5 minutes for influenza and 2 minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care. Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, N.Y., said in the press release.

Find the full press release on the Abbott Laboratories website.

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