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.
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.
Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA harrins2@ccf.org.
S M
SM
Harrington
Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
B W
http://orcid.org/0000-0002-4111-048X
BW
Buchan
Children's Medical Center of Dallas, Dallas, Texas, USA.
C
C
Doern
Scott & White Memorial Hospital, Temple, Texas, USA.
R
R
Fader
Massachusetts General Hospital, Boston, Massachusetts, USA.
M J
MJ
Ferraro
Calgary Laboratory Services, Calgary, Alberta, Canada.
D R
DR
Pillai
Massachusetts General Hospital, Boston, Massachusetts, USA.
J
J
Rychert
Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
L
L
Doyle
Becton, Dickinson and Company (BD Diagnostics), Quebec, QC, Canada.
A
A
Lainesse
Becton, Dickinson and Company (BD Diagnostics), Sparks, Maryland, USA.
T
T
Karchmer
Cincinnati Children's Hospital, Cincinnati, Ohio, USA.
J E
JE
Mortensen
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001431:Bacteriological Techniques / Q000379:methods; D002167:Campylobacter / Q000235:genetics / Q000302:isolation & purification*; D002648:Child; D002675:Child, Preschool; D003967:Diarrhea / Q000175:diagnosis / Q000382:microbiology; D005243:Feces / Q000737:chemistry / Q000382:microbiology; D005260:Female; D016905:Gram-Negative Bacterial Infections / Q000175:diagnosis* / Q000382:microbiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods; D016133:Polymerase Chain Reaction / Q000379:methods*; D011446:Prospective Studies; D012189:Retrospective Studies; D012475:Salmonella / Q000235:genetics / Q000302:isolation & purification*; D012680:Sensitivity and Specificity; D022622:Shiga Toxin 1 / Q000032:analysis* / Q000235:genetics; D022641:Shiga Toxin 2 / Q000032:analysis* / Q000235:genetics; D012760:Shigella / Q000235:genetics / Q000302:isolation & purification*; D013997:Time Factors; D014481:United States; D055815:Young Adult
D022622:Shiga Toxin 1; D022641:Shiga Toxin 2