Singh Sarishna, Newton-Foot Mae, Nel Pieter, Pienaar Colette
National Health Laboratory Service Tygerberg Academic Laboratory, Division of Medical Microbiology, Tygerberg Hospital, Tygerberg, South Africa.
Division of Medical Microbiology, Department of Pathology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Afr J Lab Med. 2022 Sep 29;11(1):1809. doi: 10.4102/ajlm.v11i1.1809. eCollection 2022.
is the number one cause of hospital-acquired diarrhoea. Accurate diagnosis of is of utmost importance as it guides patient management and infection control practices. Studies evaluating the performance of commercially available nucleic acid amplification tests (NAATs) versus algorithms are lacking in resource-limited settings.
This study assessed the performance of three commercially available tests and a two-step approach for the diagnosis of infection using toxigenic culture (TC) as the gold standard.
Two hundred and twenty-three non-duplicate loose stool samples were submitted to the National Health Laboratory Service Microbiology Laboratory at Tygerberg Hospital, Cape Town, South Africa, from October 2017 to October 2018. The samples were tested in parallel using the enzyme immunoassay (EIA) and two NAATs (Xpert and BD MAX Cdiff), and the results were compared to TC. The performance of a two-step approach consisting of the followed by the Xpert was also determined.
Of 223 faecal specimens tested, 37 (16.6%) were TC-positive. The sensitivity and specificity of the were 54.1% and 98.9%; Xpert , 86.4% and 96.8%; BD MAX Cdiff, 89.2% and 96.8%; and two-step approach, 89.2% and 96.2%.
The , in a two-step approach with the Xpert , performed similarly to the NAATs on their own and offer advantages in terms of cost and workflow in low-resource settings.
[病原体名称]是医院获得性腹泻的首要病因。准确诊断[病原体名称]至关重要，因为它指导患者管理和感染控制措施。在资源有限的环境中，缺乏评估商用核酸扩增检测（NAATs）与算法性能的研究。
本研究以产毒培养（TC）作为金标准，评估三种商用检测方法和一种两步法诊断[病原体名称]感染的性能。
2017年10月至2018年10月期间，223份非重复的稀便样本被提交至南非开普敦泰格伯格医院的国家卫生实验室服务微生物实验室。这些样本同时使用[检测试剂名称]酶免疫测定（EIA）和两种NAATs（Xpert[检测试剂名称]和BD MAX Cdiff）进行检测，并将结果与TC进行比较。还确定了由[检测试剂名称] followed by Xpert[检测试剂名称]组成的两步法的性能。
在检测的223份粪便标本中，37份（16.6%）为TC阳性。[检测试剂名称]的敏感性和特异性分别为54.1%和98.9%；Xpert[检测试剂名称]为86.4%和96.8%；BD MAX Cdiff为89.2%和96.8%；两步法为89.2%和96.2%。
[检测试剂名称]与Xpert[检测试剂名称]组成的两步法的性能与单独使用NAATs相似，并且在低资源环境中的成本和工作流程方面具有优势。
