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 (EUA) 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 (Ct) 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.
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. 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.
More information on the QIAstat-Dx portfolio can be found here
