QIAGEN have published a multicenter clinical study demonstrating the accuracy of its QIAstat-Dx syndromic testing solution for diagnosing the causes of acute gastroenteritis. The QIAstat-Dx Gastrointestinal Panel delivered high performance compared to other, existing multiplex tests in this study which evaluated 385 patient samples at university hospital laboratories across Europe.

The study showed the QIAstat-Dx Gastrointestinal Panel was highly sensitive (98.2% positive percent agreement, a measure of ability to detect pathogens) and specific (99.9% negative percent agreement, a measure of ability to identify true negative samples). Multiple pathogens were identified in nearly one-third of the patient samples that tested positive. Authors emphasized the system’s “ease of use” and that the system and assay yielded results in approximately one hour. The study also cited the ability of the QIAstat-Dx panel to provide cycle threshold (CT) values and amplification curves, quantitative indications of the amount of nucleic acids detected, as a unique advantage in interpreting diagnostic findings for gastrointestinal syndromes, which can be complicated by co-infections or false positives in testing. These are important capabilities which other currently widely used syndromic platforms do not offer.

The article, “Multicenter evaluation of the new QIAstat Gastrointestinal Panel for the rapid syndromic testing of acute gastroenteritis,” has been accepted for publication by the European Journal of Clinical Microbiology & Infectious Diseases (EJCMID) and is available online. The study was conducted at Copenhagen University Hospital Hvidovre in Denmark and University Hospital of Bonn in Germany.

“Insights from our QIAstat-Dx syndromic testing solution offer real value for clinicians as rapid and efficient decision support for their evaluation of complex and sometimes life-threatening infections. This new study adds to the rapidly growing base of evidence that the QIAstat-Dx gastrointestinal panel delivers excellent results in an easy-to-use workflow,” said Thierry Bernard, Senior Vice President and Head of Molecular Diagnostics for QIAGEN. “Traditional gastrointestinal testing is costly, time-consuming and labor-intensive. The QIAstat-Dx GI panel addresses these challenges and can thereby create real value of laboratories, clinicians and patients. Demand for syndromic testing is growing rapidly, and QIAstat-Dx brings the next-generation solution to accurately evaluate infections and other diseases that manifest as a set of symptoms with uncertain causes. The system has many unique advantages, including being the only solution to provide CT values to users.”

Introduced in Europe in early 2018 and the United States in mid-2019, the QIAstat-Dx system enables fast, cost-effective and easy-to-use syndromic testing with novel Sample to Insight solutions. The QIAstat-Dx Gastrointestinal Panel provides differential detection of more than 20 bacterial, viral and parasitic pathogens implicated in gut infections. The panel is already available in Europe. The QIAstat-Dx Respiratory Panel, for detection of more than 20 common viral and bacterial infections in respiratory syndromes, is currently available in Europe and the United States.

QIAGEN is developing a broad pipeline of planned assays for the QIAstat-Dx content menu, spanning infectious diseases, oncology, companion diagnostics and other disease areas.