Oct. 29, 2018—Abbott announced FDA clearance and CLIA waiver of its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.
The Influenza A & B 2 assay detects and differentiates influenza A and B virus in 13 minutes or less, with early call out of positive results in as few as five minutes. The Strep A 2 provides molecular detection of group A Streptococcus bacterial nucleic in six minutes or less, with call out of positive results as few as two minutes; no culture confirmation is required for negative results.
“The ability to obtain early call outs for positive test results with molecular accuracy in as little as five minutes for influenza and two minutes for Strep A is a game-changing development that allows prompt treatment decisions at the point of care,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories, Lake Success, NY, said in a press release from Abbott.
The tests are available on the company’s ID Now platform (formerly Alere i).