Multicenter evaluation of the BD max enteric bacterial panel PCR assay for rapid detection of Salmonella spp., Shigella spp., Campylobacter spp. (C. jejuni and C. coli), and Shiga toxin 1 and 2 genes. J Clin Microbiol 2015 May;53(5):1639-47
Date
03/06/2015Pubmed ID
25740779Pubmed Central ID
PMC4400754DOI
10.1128/JCM.03480-14Scopus ID
2-s2.0-84928036946 (requires institutional sign-in at Scopus site) 72 CitationsAbstract
Diarrhea 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 Salmonella spp., Shigella spp., Campylobacter jejuni, and Campylobacter coli and 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 Salmonella spp., 99.1% and 99.7% for Shigella spp., 97.2% and 98.4% for C. jejuni and 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 Salmonella spp., 99.2% and 100% for Shigella spp., 97.5% and 99.0% for C. jejuni and 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.
Author List
Harrington SM, Buchan BW, Doern C, Fader R, Ferraro MJ, Pillai DR, Rychert J, Doyle L, Lainesse A, Karchmer T, Mortensen JEAuthor
Blake W. Buchan PhD Professor in the Pathology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Aged
Aged, 80 and over
Bacteriological Techniques
Campylobacter
Child
Child, Preschool
Diarrhea
Feces
Female
Gram-Negative Bacterial Infections
Humans
Infant
Infant, Newborn
Male
Middle Aged
Molecular Diagnostic Techniques
Polymerase Chain Reaction
Prospective Studies
Retrospective Studies
Salmonella
Sensitivity and Specificity
Shiga Toxin 1
Shiga Toxin 2
Shigella
Time Factors
United States
Young Adult
