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FDA clears Abbott’s assays for influenza and Streptococcus

October 26, 2018

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The new Influenza A & B 2 assay has been designed for the molecular identification and differentiation of the influenza A and B virus strains within 13 minutes. Abbott said the assay can display positive results in five minutes.

Abbott developed the Strep A 2 test for the detection of Group A Streptococcus bacterial nucleic acid, which is known to cause bacterial pharyngitis.

This assay is claimed to detect the bacteria twice more rapidly than existing molecular tests, delivering results in six minutes or less, with a call out of positive results in two minutes. Strep A 2 test does not require culture confirmation for negative results.

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