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New Respiratory Syndromic Testing Panel Provides Fast and Accurate Results

By LabMedica International staff writers
Posted on 14 May 2024
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Image: The QIAstat-Dx Respiratory Panel Plus has received U.S. FDA clearance (Photo courtesy of QIAGEN)
Image: The QIAstat-Dx Respiratory Panel Plus has received U.S. FDA clearance (Photo courtesy of QIAGEN)

Respiratory tract infections are a major reason for emergency department visits and hospitalizations. According to the CDC, the U.S. sees up to 41 million influenza cases annually, resulting in several hundred thousand hospitalizations and as many as 51,000 deaths. Syndromic testing systems have improved the detection of co-infections, thus reducing the need for further testing. These systems provide rapid results, enabling healthcare providers to make timely decisions and stop unnecessary antibiotic treatments when viral pathogens are identified, which helps reduce antibiotic use and supports responsible antimicrobial stewardship. A new respiratory syndromic testing panel now allows for the accurate diagnosis of respiratory infections and the detection of co-infections. This panel delivers results in about one hour and requires less than one minute of hands-on time, while providing easy access to cycle threshold (Ct) values and amplification curves.

QIAGEN N.V. (Venlo, the Netherlands) has received clearance from the U.S. Food and Drug Administration (FDA) for its QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use. This panel is intended to aid in diagnosing upper respiratory infections, covering 21 viral and bacterial targets. It was initially authorized under a U.S. FDA Emergency Use Authorization (EUA) as the QIAstat-Dx Respiratory SARS-CoV-2 Panel. The panel utilizes QIAstat-Dx’s capability to quickly amplify multiple genetic targets simultaneously using real-time PCR technology, providing results in approximately one hour with minimal hands-on time. The Ct values and amplification curves are easily accessible, offering additional clinical data to healthcare professionals.

QIAGEN has also introduced the QIAstat-Dx Analyzer 2.0, an upgraded diagnostic system featuring the Remote Results Application—a unique function in the field of syndromic testing. This feature enables users to access, review, and approve diagnostic test results from both desktop and mobile devices, regardless of their location, thereby enabling seamless interaction across the healthcare system. The QIAstat-Dx syndromic testing, equipped with cloud-based connectivity and epidemiological insights, is available in over 100 countries, with more than 4,000 units currently in use. The QIAstat-Dx is offered in two versions: the standard QIAstat-Dx Analyzer, which can accommodate up to four Analytical Modules, and the higher-capacity QIAstat-Dx Rise version, which can handle up to 160 tests per day using eight Analytical Modules. QIAGEN is actively expanding its QIAstat-Dx range in the U.S., with a Gastrointestinal Panel under FDA review and a Meningitis/Encephalitis Panel in development.

“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,” said Fernando Beils, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN. “This comprehensive diagnostic tool will improve patient care, support responsible antimicrobial stewardship, and reduce the burden on healthcare systems.”

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