Multicenter Evaluation of the BD Max Enteric Bacterial Panel PCR Assay for Rapid Detection of Salmonellaspp., Shigellaspp., Campylobacterspp. (C. jejuniand C. coli), and Shiga Toxin 1 and 2 Genes

Autor: Harrington, S. M., Buchan, B. W., Doern, C., Fader, R., Ferraro, M. J., Pillai, D. R., Rychert, J., Doyle, L., Lainesse, A., Karchmer, T., Mortensen, J. E.
Zdroj: Journal of Clinical Microbiology; March 2015, Vol. 53 Issue: 5 p1639-1647, 9p
Abstrakt: ABSTRACTDiarrhea due to enteric bacterial pathogens causes significant morbidity and mortality in the United States and worldwide. However, bacterial pathogens may be infrequently identified. Currently, culture and enzyme immunoassays (EIAs) are the primary methods used by clinical laboratories to detect enteric bacterial pathogens. We conducted a multicenter evaluation of the BD Max enteric bacterial panel (EBP) PCR assay in comparison to culture for the detection of Salmonellaspp., Shigellaspp., Campylobacter jejuni, and Campylobacter coliand an EIA for Shiga toxins 1 and 2. A total of 4,242 preserved or unpreserved stool specimens, including 3,457 specimens collected prospectively and 785 frozen, retrospective samples, were evaluated. Compared to culture or EIA, the positive percent agreement (PPA) and negative percent agreement (NPA) values for the BD Max EBP assay for all specimens combined were as follows: 97.1% and 99.2% for Salmonellaspp., 99.1% and 99.7% for Shigellaspp., 97.2% and 98.4% for C. jejuniand C. coli, and 97.4% and 99.3% for Shiga toxins, respectively. Discrepant results for prospective samples were resolved with alternate PCR assays and bidirectional sequencing of amplicons. Following discrepant analysis, PPA and NPA values were as follows: 97.3% and 99.8% for Salmonellaspp., 99.2% and 100% for Shigellaspp., 97.5% and 99.0% for C. jejuniand C. coli, and 100% and 99.7% for Shiga toxins, respectively. No differences in detection were observed for samples preserved in Cary-Blair medium and unpreserved samples. In this large, multicenter study, the BD Max EBP assay showed superior sensitivity compared to conventional methods and excellent specificity for the detection of enteric bacterial pathogens in stool specimens.
Databáze: Supplemental Index