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
Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA
Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
J Clin Microbiol. 2015 May;53(5):1639-47. doi: 10.1128/JCM.03480-14. Epub 2015 Mar 4.
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.
在美国及全球范围内，由肠道细菌病原体引起的腹泻会导致严重的发病和死亡。然而，细菌病原体可能很少被识别出来。目前，培养和酶免疫测定法（EIAs）是临床实验室用于检测肠道细菌病原体的主要方法。我们开展了一项多中心评估，将BD Max肠道细菌检测板（EBP）PCR检测法与培养法进行比较，以检测沙门氏菌属、志贺氏菌属、空肠弯曲菌和结肠弯曲菌，并采用EIA法检测志贺毒素1和2。总共评估了4242份保存或未保存的粪便标本，其中包括3457份前瞻性收集的标本和785份冷冻的回顾性样本。与培养法或EIA法相比，所有标本合并后BD Max EBP检测法的阳性百分一致性（PPA）和阴性百分一致性（NPA）值如下：沙门氏菌属分别为97.1%和99.2%，志贺氏菌属分别为99.1%和99.7%，空肠弯曲菌和结肠弯曲菌分别为97.2%和98.4%，志贺毒素分别为97.4%和99.3%。前瞻性样本的差异结果通过替代PCR检测法和扩增子双向测序得以解决。经过差异分析后，PPA和NPA值如下：沙门氏菌属分别为97.3%和99.8%，志贺氏菌属分别为99.2%和100%，空肠弯曲菌和结肠弯曲菌分别为97.5%和99.0%，志贺毒素分别为100%和99.7%。在Cary-Blair培养基中保存的样本和未保存的样本在检测方面未观察到差异。在这项大型多中心研究中，BD Max EBP检测法与传统方法相比显示出更高的灵敏度，并且在检测粪便标本中的肠道细菌病原体方面具有出色的特异性。
