Health care company Abbott (NYSE:ABT) reported on Thursday the receipt of the US Food and Drug Administration's (FDA) clearance for its next-generation Influenza A & B 2 and Strep A 2 molecular assays available on the ID NOW platform (formerly Alere i) for point-of-care testing in a broad range of outpatient and inpatient settings.
The company said the new A & B 2 and Strep A 2 molecular assays enable the fastest-ever time to molecular influenza A & B and Strep A results at the point of care.
ID NOW, which is the first CLIA-waived point-of-care molecular platform, is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. The unique ID NOW isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing clinicians to make effective clinical decisions during a patient visit, added the company.
According to the company, 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.
Additionally, 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, revealed the company.
Each year, a combination of influenza A and B virus strains circulate within the US. Pharyngitis, or inflammation of the pharynx causing sore throat, is diagnosed in 11m patients in US emergency departments and ambulatory settings annually. Group A streptococcus (GAS) is the most common bacterial cause of acute pharyngitis.
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