A world leader advancing practices in medicine, science and technology, Abbott Laboratories recently announced that it received the U.S. Food and Drug Administration (FDA) clearance for its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing. The new assays are available in outpatient and inpatient settings where patients are increasingly accessing healthcare services, including emergency rooms, physician offices, walk-in clinics and urgent care centers.
These new assays enable faster molecular influenza A & B and Strep A results at the point of care, thus empowering clinicians to more quickly make the right diagnosis and prescribe the right treatment.
- The Influenza A & B 2 assay offers the fastest POC 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. It also 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.
Sharon Bracken, Senior Vice President, Rapid Diagnostics, Abbott, said, "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. 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."
Currently available on the ID NOW® platform (formerly Alere i), both new assays have also been granted a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver.