Qiagen’s QIAstat-Dx demonstrates excellent performance in multicenter clinical study

Qiagen has announced the publication of 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 percent positive-percent agreement, a measure of ability to detect pathogens) and specific (99.9 percent 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.

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