Simplexa Flu/RSV Test Cleared for Eight More Strains

Focus Diagnostics, a part of Quest Diagnostics, announced that its Simplexa Flu A/B & RSV Direct Kit has been cleared by the Food and Drug Administration (FDA) for eight additional influenza strains: H7N9, H3N2 (Minnesota and Indiana strains) as well as H1N1 (2011), H3N2 (Ohio and Texas strains), and influenza B (Brisbane and Wisconsin strains).

The Simplexa Flu A/B & RSV Direct Kit is a real-time RT-PCR molecular test that was initially granted clearance in July 2012 for in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs from patients with respiratory tract infection with clinical epidemiological risk factors.

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The test can report results in about an hour through a novel method that eliminates nucleic acid extraction, which is usually a time consuming technique.

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