QIAGEN expands QIAstat-Dx syndromic testing menu in the U.S. with launch of molecular test to improve gastrointestinal care

June 4, 2024
U.S. FDA clears QIAstat-Dx Gastrointestinal Panel 2 for use in clinical settings.

QIAGEN announced the launch of the QIAstat-Dx Gastrointestinal Panel 2 in the United States. The launch comes after the recent clearance of the syndromic test for clinical use by the U.S. Food and Drug Administration (FDA).

The QIAstat-Dx Gastrointestinal Panel 2 takes about an hour to simultaneously look for up to 16 clinically relevant bacterial, viral and parasitic pathogens that cause most GI infections.

The panel leverages QIAstat-Dx’s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, which often requires samples to be incubated for at least 24 hours and up to 10 days of specimen collection. Software interprets signals from the reaction and provides positive or negative results for each pathogen. QIAstat-Dx additionally provides easy-to-view cycle threshold (Ct) values and amplification curves that can offer additional insights not available with end-point PCR or other techniques.

The new panel expands QIAGEN’s U.S. menu for syndromic testing, building on the use of the QIAstat-Dx Respiratory Panel Plus that can identify 21 pathogens causing respiratory infections from viral and bacterial pathogens. Both Panels are available as cost-efficient, single-use cartridges that slot easily into the QIAstat-Dx Analyzer 1.0. As they contain all reagents, set up takes less than a minute and requires no precision pipetting.

QIAstat-Dx is available in two formats: The QIAstat-Dx version that brings together up to four Analytical Modules into one integrated system, and the QIAstat-Dx Rise higher-capacity version that provides comprehensive testing for up to 160 tests per day using eight Analytical Modules. QIAstat-Dx Rise is available with CE-IVD marking in Europe and other countries that accept this marking. 

With a QIAstat-Dx Connectivity plan, QIAstat-Dx connects to the QIAsphere cloud-based platform that provides remote monitoring of the instruments and test status, allowing customers to receive push notifications on their personal devices. It can monitor an unlimited number of instruments across different hospitals or satellite labs. Connectivity is achieved through the Qbase hub, which can be connected to QIAstat-Dx in minimal time through hospitals’ LAN or Wi-Fi network, ensuring sensitive patient data remains within the hospital network.

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