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.

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.