Previously authorized under an FDA EUA, the panel helps diagnose upper respiratory infections, covering 21 viral and bacterial targets.

RT’s Three Key Takeaways:

  1. The FDA has cleared the QIAstat-Dx respiratory panel plus, which can detect 21 viral and bacterial pathogens, delivering results in about one hour with less than one minute of hands-on time.
  2. The panel helps reduce unnecessary antibiotic use, supporting “responsible antimicrobial stewardship” and improving patient care.
  3. Qiagen’s QIAstat-Dx Analyzer 2.0 introduces remote result viewing and collaboration capabilities, expanding the reach and efficiency of syndromic testing across healthcare systems.

The US Food and Drug Administration (FDA) has cleared Qiagen’s 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 US FDA Emergency Use Authorization as the QIAstat-Dx respiratory SARS-CoV-2 panel. 

PCR Technology

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, according to a release from Qiagen.

“The QIAstat-Dx Respiratory Panel Plus addresses the challenges faced by clinicians in diagnosing respiratory infections, streamlining the process and providing accurate results in about one hour,” says Fernando Beils, senior vice president and head of the molecular diagnostics business area at Qiagen, in a release. “This comprehensive diagnostic tool will improve patient care, support responsible antimicrobial stewardship, and reduce the burden on healthcare systems.”

Expanding Diagnostic Portfolio

Qiagen is working on expanding its portfolio for QIAstat-Dx in the US, 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.

New Features and Global Reach

Qiagen recently launched the QIAstat-Dx Analyzer 2.0. The upgraded diagnostic system introduces the remote results application, a feature in the syndromic testing space. It allows users to view, comment on, and confirm diagnostic test results directly from their desktop and mobile devices in any location, facilitating seamless collaboration across the healthcare system. 

QIAstat-Dx syndromic testing with cloud-based connectivity and epidemiological insights is available in more than 100 countries, with more than 4,000 instruments placed worldwide.

QIAstat‑Dx is available in two formats: the QIAstat-Dx Analyzer version, which integrates up to four analytical modules, and the QIAstat-Dx Rise higher-capacity version, providing comprehensive testing for up to 160 tests per day using eight analytical modules.

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