Qiagen N.V. 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) and marks a significant step forward in improving the accuracy and efficiency of gastrointestinal (GI) infection diagnosis. 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.

Acute infectious gastroenteritis is a common reason for hospitalizations and outpatient physician visits in the U.S., with an estimated 180 million cases per year. The panel leverages QIAstat-Dx?s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction ? an important advance compared to traditional microbiological testing, 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. The U.S. launch supports healthcare providers with diagnosing and treating patients quickly and accurately. They will be able to quickly isolate those at risk of transmitting infections and identify negative cases sooner, reducing the burden of unnecessary testing and treatment costs on the healthcare system and patients.

Syndromic tests have also been shown to improve the detection of co-infections, reducing the need for additional testing like endoscopies. 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. QIAstat-Dx solutions and syndromic tests to support diagnosing diseases are available in more than 100 countries worldwide, including the U.S. and many across Europe.

More than 4,000 cumulative systems were installed worldwide at the end of 2023. Hospitals, laboratories and clinics value the QIAstat-Dx range as an easy-to-use automated solution for the reliable detection of various pathogens. 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, reducing system downtime and enabling fast and accurate syndromic testing.

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.