title: Validation of the EntericBio Panel II® multiplex polymerase chain reaction system for detection of Campylobacter spp., Salmonella spp., Shigella spp., and verotoxigenic E. coli for use in a clinical diagnostic setting.
abstract: A total of 717 faeces samples were tested prospectively using the EntericBio Panel II® detection system (Serosep, Limerick, Ireland), in parallel with routine laboratory testing, which combines the EntericBio® system with retrospective culture of each specimen where a target is detected. Discrepancy analysis was conducted using molecular methods. The EntericBio Panel II® assay produced 585 negative and 132 positive results, namely, Campylobacter spp. (n = 66); SLT 1 and/or SLT 2 (n = 64); Salmonella spp. (n = 5); and Shigella spp. (n = 0). Three samples were positive for more than 1 target. Of these results, 4 Campylobacter spp. detections and 4 SLT 1/ SLT 2 detections remained unconfirmed, and the system failed to detect 2 Campylobacter spp. targets detected by routine laboratory detection. The sensitivity, specificity, positive predictive value, negative predictive value, and efficiency were calculated to be 98.4%, 98.7%, 93.9%, 99.7%, and 98.6%, respectively.
authors.affiliation: Department of Biological Sciences, Cork Institute of Technology, Bishopstown, Cork, Ireland.
authors.forename: Monika
authors.initials: M
authors.lastname: Koziel
authors.forename: Dan
authors.initials: D
authors.lastname: Corcoran
authors.forename: Isabelle
authors.initials: I
authors.lastname: O'Callaghan
authors.forename: Roy D
authors.initials: RD
authors.lastname: Sleator
authors.forename: Brigid
authors.initials: B
authors.lastname: Lucey
mesh_terms: D002167:Campylobacter / Q000235:genetics / Q000302:isolation & purification*; D004756:Enterobacteriaceae Infections / Q000175:diagnosis* / Q000382:microbiology; D005243:Feces / Q000382:microbiology; D006801:Humans; D007494:Ireland; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012475:Salmonella / Q000235:genetics / Q000302:isolation & purification*; D012680:Sensitivity and Specificity; D054323:Shiga-Toxigenic Escherichia coli / Q000235:genetics / Q000302:isolation & purification*; D012760:Shigella / Q000235:genetics / Q000302:isolation & purification*