Image created by Dr. Michael J. Miller
The FDA cleared Qiagen’s QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use.
This clearance builds on the authorization of five panels for use on the QIAstat-Dx system within the last 10 months.
This newly cleared panel focuses on bacterial infections, covering Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella and Yersinia enterocolitica. These bacteria are among the leading causes of acute infectious gastroenteritis, which results in an estimated 179 million cases annually in the United States, driving significant numbers of outpatient visits and hospitalizations (Am J Gastroenterol 2023;118[6]:1069-1079).
The newly cleared panel is designed to complement the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral) panel that covers Campylobacter, Salmonella, STEC, Shigella and norovirus.
The QIAstat-Dx Gastrointestinal Panel 2 Mini B runs on Qiagen’s QIAstat-Dx system and leverages its ability to quickly multiply many genetic targets using real-time polymerase chain reaction technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold values and amplification curves provide laboratories with additional information in the context of coinfections and are instantly viewable on the instrument touchscreen, with no additional software required.
Qiagen now offers both comprehensive and targeted syndromic GI panels, allowing laboratories to tailor testing to their specific requirements. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is optimized for settings where bacterial pathogens are the primary concern, complementing the previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V panel, which includes both bacterial and viral targets.