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 Escherichia coli, 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 Campylobacter sp., Salmonella sp., Shigella sp./enteroinvasive E. coli (EIEC), Yersinia enterocolitica, enterohemorrhagic E. coli (EHEC), and enterotoxigenic E. coli (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 Salmonella sp. and EHEC was perfect. The kit has the advantage of only detecting pathogenic Y. enterocolitica. Its performance for Campylobacter is very satisfactory.

中文翻译：

---

Novodiag细菌GE +多重PCR分析的性能评估。

历史上，肠道细菌感染的细菌学诊断一直基于琼脂平板上的培养。但是，培养物可能缺乏敏感性，并且有些肠病原体，例如大肠杆菌的病原体，可以摆脱常规诊断。我们的目标是评估Novodiag Bacterial GE +试剂盒在急性社区腹泻中检测肠道致病菌的分析性能。在这项研究中，我们纳入了251份大便（198份回顾性研究和53份前瞻性研究）。在没有完美的金标准物（缺乏培养物敏感性）的情况下，使用复合参考标准物（CRS）计算了分析性能。如果培养呈阳性，则CRS定义为阳性；如果培养阴性，则BD Max扩展肠道细菌检测和/或其他实时PCR（RT-PCR）检测为阳性，则CRS定义为阳性。在251个样本中，200个为阳性，51个为阴性。Novodiag细菌GE +试剂盒对弯曲杆菌属，沙门氏菌属，志贺氏菌/侵袭性大肠杆菌（EIEC），小肠结肠炎耶尔森菌，肠出血性大肠杆菌（EHEC）和产肠毒素的大肠杆菌（ETEC）的范围为98.98至100％，特异性范围为98.08至100％，阳性预测值（ PPVs的范围从88.24到100％，阴性预测值（NVP）的范围从99.36到100％。Novodiag Bacterial GE +试剂盒的分析性能非常出色。它可以用作细菌性胃肠炎快速诊断的常规工具。尽管主要样品使用了eNAT管稀释液，但沙门氏菌的检测仍在进行中。EHEC非常完美。该试剂盒的优势在于仅检测致病性小肠结肠炎耶尔森氏菌。它对弯曲杆菌的性能非常令人满意。