Roy Charly, Robert David, Bénéjat Lucie, Buissonnière Alice, Ducournau Astrid, Mégraud Francis, Bessède Emilie, Boraud Delphine, Lehours Philippe
University Hospital Pellegrin, Bordeaux, France.
EXALAB, Labexa Group, Le Haillan, France.
J Clin Microbiol. 2020 Sep 22;58(10). doi: 10.1128/JCM.01033-20.
The bacteriological diagnosis of intestinal bacterial infections has historically been based on culture on agar plates. However, culture may lack sensitivity, and some enteropathogens, such as pathovars of , may escape routine diagnosis. Our goal was to evaluate the analytical performance of the Novodiag Bacterial GE+ kit for the detection of enteropathogenic bacteria in acute community diarrhea. We included 251 stools in this study (198 retrospective and 53 prospective). The analytical performance was calculated using a composite reference standard (CRS) in the absence of a perfect gold standard (lack of sensitivity of culture). The CRS was defined as positive if culture was positive or, in case of a negative culture, if the BD Max extended enteric bacterial panel and/or other real-time PCR (RT-PCR) tests were positive. Of the 251 samples, 200 were positive, and 51 were negative. Overall sensitivities of the Novodiag Bacterial GE+ kit for sp., sp., sp./enteroinvasive (EIEC), , enterohemorrhagic (EHEC), and enterotoxigenic (ETEC) ranged from 98.98 to 100%, specificities ranged from 98.08 to 100%, positive predictive values (PPVs) ranged from 88.24 to 100%, and negative predictive values (NVPs) ranged from 99.36 to 100%. The analytical performance of the Novodiag Bacterial GE+ kit is excellent. It can be used as a routine tool in the rapid diagnosis of bacterial gastroenteritis. Despite the eNAT tube dilution of the primary sample, the detection of sp. and EHEC was perfect. The kit has the advantage of only detecting pathogenic Its performance for is very satisfactory.
肠道细菌感染的细菌学诊断历来基于琼脂平板培养。然而，培养可能缺乏敏感性，一些肠道病原体，如某些菌的致病型，可能会逃过常规诊断。我们的目标是评估Novodiag细菌基因+检测试剂盒在急性社区腹泻中检测肠道致病菌的分析性能。本研究纳入了251份粪便样本（198份回顾性样本和53份前瞻性样本）。在缺乏完美金标准（培养缺乏敏感性）的情况下，使用综合参考标准（CRS）计算分析性能。如果培养结果为阳性，或者在培养结果为阴性的情况下，如果BD Max扩展肠道细菌检测板和/或其他实时PCR（RT-PCR）检测结果为阳性，则CRS定义为阳性。在251份样本中，200份为阳性，51份为阴性。Novodiag细菌基因+检测试剂盒对某些菌属、某些菌属、某些菌属/肠侵袭性大肠杆菌（EIEC）、、肠出血性大肠杆菌（EHEC）和产肠毒素大肠杆菌（ETEC）的总体敏感性范围为98.98%至100%，特异性范围为98.08%至100%，阳性预测值（PPV）范围为88.24%至100%，阴性预测值（NPV）范围为99.36%至100%。Novodiag细菌基因+检测试剂盒的分析性能非常出色。它可作为细菌性胃肠炎快速诊断的常规工具。尽管对原始样本进行了eNAT管稀释，但对某些菌属和EHEC的检测效果完美。该试剂盒的优点是只检测致病的，其对的检测性能非常令人满意。
