title: Site-specific clinical evaluation of the Luminex xTAG gastrointestinal pathogen panel for detection of infectious gastroenteritis in fecal specimens.
abstract: We evaluate the clinical performance of the Luminex xTAG gastrointestinal (GI) pathogen in vitro diagnostic (IVD) assay in a comparison between clinical and public health laboratories. The site reproducibility study showed 98.7% sensitivity with high positive and negative agreement values (96.2% and 99.8%, respectively), while assay performance against confirmatory methods resulted in 96.4% sensitivity with similar positive and negative agreement values (90.1% and 99.5%, respectively). High-throughput detection of multiple GI pathogens improved turnaround time, consolidated laboratory workflow, and simplified stool culture practices, thus reducing the overall cost and number of specimens processed.
authors.affiliation: Le Bonheur Children's Hospital, Memphis, Tennessee, USA.
authors.forename: Anami
authors.initials: A
authors.lastname: Patel
authors.affiliation: City of Milwaukee Health Department Laboratory, Milwaukee, Wisconsin, USA.
authors.forename: Jose
authors.initials: J
authors.lastname: Navidad
authors.affiliation: City of Milwaukee Health Department Laboratory, Milwaukee, Wisconsin, USA sbhatt@milwaukee.gov.
authors.forename: Sanjib
authors.initials: S
authors.lastname: Bhattacharyya
mesh_terms: D000293:Adolescent; D000328:Adult; D001419:Bacteria / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D002648:Child; D002675:Child, Preschool; D005243:Feces / Q000382:microbiology* / Q000821:virology*; D005260:Female; D005759:Gastroenteritis / Q000175:diagnosis*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors; D014780:Viruses / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*