QIAGEN announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use. The QIAstat-Dx Respiratory Panel Plus is designed to support clinical decision-making in diagnosing upper respiratory infections and covers 21 viral and bacterial targets. It was previously authorized under a U.S. FDA Emergency Use Authorization as the QIAstat-Dx Respiratory SARS-CoV-2 Panel.

The panel leverages QIAstat-Dx?s ability to quickly amplify many genetic targets at once using real-time PCR technology, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold values and amplification curves are easily viewable and provide healthcare professionals with additional clinical information. QIAGEN is working on expanding its portfolio for QIAstat-Dx in the U.S., with a Gastrointestinal Panel currently under FDA review and a Meningitis/Encephalitis Panel.

Syndromic testing systems like QIAstat-Dx have been shown to improve the detection of co-infections, reducing the need for additional testing. By providing fast results, syndromic testing enables healthcare providers to make informed decisions and discontinue empiric antibiotic treatment when viral pathogens are detected, reducing overall antibiotic usage and supporting the goal of responsible antimicrobial stewardship.