QIAstat-Dx gastrointestinal panel and Luminex xTAG gastrointestinal pathogen panel comparative evaluation.

The diagnosis of acute gastroenteritis is an ongoing clinical challenge in terms of identification of the etiologic agent, time to results, and appropriate treatment. Rapid detection of gastrointestinal pathogens is needed to improve patient care. This study evaluates the performance of the QIAstat-Dx gastrointestinal panel (Q-GP; Investigational Use Only) compared to the Luminex xTAG gastrointestinal pathogen panel (L-GPP; US-IVD). Using 245 stool specimens, we evaluated 10 different targets including rotavirus, norovirus, , , , , , O157, enterotoxigenic (ETEC), and Shiga toxin-producing (STEC). For the viral targets, the percent positive agreement (PPA) for rotavirus was 100% ( = 19) and that for norovirus was 91% (20/22). For the parasitic targets, the PPA was 100% for and ( = 18 and = 23, respectively). The PPA was 96% for (22/23) and (22/23), and the PPA for was 100% ( = 23). For the targets, a PPA of 94% was achieved for STEC (32/34) and 96% for ETEC (24/25). We did not assess PPA for the O157 target as the Q-GP O157 call is dependent. The negative percent agreement across all targets was 99.1%. Our study suggests that QIAstat-Dx GP provides comparable results to Luminex GPP based on the analysis of targets found on both panels.