2026-04-14T02:39:56Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/137112025-10-24T10:20:45Zcom_2072_378070com_2072_378040col_2072_378092

00925njm 22002777a 4500 dc Szymczak, Wendy author Engsbro, Anne Line author Lisby, Jan Gorm author Granato, Paul author Ledeboer, Nathan author González-López, Juan José author 2025-09-22T10:04:47Z 2025-09-22T10:04:47Z 2025-08 Diarrhea; Ggastrointestinal infection; Syndromic testing Diarrea; Infección gastrointestinal; Pruebas sindrómicas Diarrea; Infecció gastrointestinal; Proves sindròmiques The QIAstat-Dx Gastrointestinal Panel 2 (GI2 Panel) is a sample-to-answer multiplex PCR instrument that can detect 17 targets in a run time of about 80 minutes. The performance of the QIAstat-Dx GI2 Panel was evaluated by testing 1,939 prospective, 119 prospectively collected and then archived positive clinical samples and 750 retrospective clinical specimens across 13 sites in Europe and the United States. Specimens tested included bulk stool samples preserved in modified Cary-Blair transport medium. For most targets, results were compared to those of the FilmArray GI panel (13/17), and discordant results were adjudicated with a third assay. For the remaining targets (4/17), a composite comparator method was used, which included three comparator assays for each target. Before discordant resolution, the QIAstat-Dx GI2 Panel positive percent agreement (PPA) was 95% or greater for 5/17 targets (Campylobacter, E. coli O157, Cryptosporidium, Cyclospora cayetanensis, and Giardia lamblia) and 90% or greater for 11/17 targets: adenovirus F40/F41, astrovirus, norovirus GI/GII, rotavirus A, Plesiomonas shigelloides, enteropathogenic Escherichia coli, enterotoxigenic E. coli, Salmonella, Yersinia enterocolitica, Shiga-like toxin E. coli (STEC) stx1/stx2, and Shigella/enteroinvasive E. coli. No cases of Entamoeba histolytica were encountered during the clinical study. The negative percent agreement (NPA) was >98.9% for all QIAstat-Dx GI2 Panel targets. The three most common pathogens identified in single and co-infections were enteropathogenic E. coli (9.9%), Campylobacter (5.2%), and norovirus GI/GII (3.1%). In summary, this clinical study examined more than 2,800 samples from Europe and the U.S. using the QIAstat-Dx GI2 Panel and identified 90%-100% PPA and 99% NPA for its 17 targets.IMPORTANCEThe manuscript highlights the significance and impact of the QIAstat-Dx GI2 Panel, a sample-to-answer multiplex PCR instrument capable of detecting 17 targets in approximately 80 minutes. This comprehensive clinical study, conducted across 13 sites in Europe and the United States, evaluated the performance of the panel using over 2,800 clinical samples. The results demonstrate a high accuracy of the QIAstat-Dx GI2 panel, with a PPA equal to or higher than 90% for all targets and an NPA greater than 98.9% for all targets. These findings underscore the reliability and effectiveness of the GI2 panel in the rapid and precise detection of gastrointestinal pathogens, which is crucial for timely diagnosis and treatment of infections. http://hdl.handle.net/11351/13711 Gastroenteritis - Diagnòstic molecular Reacció en cadena de la polimerasa DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis Other subheadings::Other subheadings::/diagnosis ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Genetic Techniques::Nucleic Acid Amplification Techniques::Polymerase Chain Reaction::Multiplex Polymerase Chain Reaction ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis Otros calificadores::Otros calificadores::/diagnóstico TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::técnicas genéticas::técnicas de amplificación de ácidos nucleicos::reacción en cadena de la polimerasa::reacción en cadena de la polimerasa múltiple Multicenter evaluation of the QIAstat-Dx Gastrointestinal Panel 2, a multiplex PCR platform for the diagnosis of acute gastroenteritis