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Qiagen Gets FDA Clearance for Gastrointestinal Panels on QiaStat-Dx Rise System

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    Qiagen Gets FDA Clearance for Gastrointestinal Panels on QiaStat-Dx Rise System

    Laboratories can now run QiaStat-Dx Respiratory and GI panels on QiaStat-Dx Rise, an automated high-throughput version of the QiaStat-Dx system that received FDA clearance in September. Both platforms run real-time PCR panels designed to detect multiple pathogens associated with similar symptoms in a single test, as well as targeted "Mini" panels that focus on a smaller group of pathogens.

    The newly cleared GI panels are the QiaStat-Dx Gastrointestinal Panel 2, which detects 16 bacterial, viral, and parasitic pathogens from a single stool sample, including clinically relevant Shiga toxin-producing Escherichia coli (STEC) subtypes such as stx2f; and the QiaStat-Dx GI Panel 2 Mini B and Mini B&V, which provide targeted detection of five gastrointestinal pathogens including STEC.

    Results are delivered in about one hour with less than one minute of hands-on time per test. QiaStat-Dx systems provide cycle threshold values and amplification curves in the same reaction, giving laboratories additional context in cases of co-infection, Qiagen said.

 
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