Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan; Collaborative Research Centre of Okayama University for Infectious Diseases at ICMR-NICED, Kolkata, India.
Clin Microbiol Infect. 2022 Feb;28(2):155-162. doi: 10.1016/j.cmi.2021.08.027. Epub 2021 Sep 15.
Cholera is an acute diarrheal disease caused by Vibrio cholerae O1 or O139. Cholera rapid diagnostic tests (RDTs) are widely used to screen for cholera cases. However, their accuracy has not been systematically reviewed.
To evaluate the diagnostic accuracy of cholera RDTs.
Systematic review and meta-analysis.
Medline, EMBASE and Web of science through to November 2020; references of included studies and a technical guidance on cholera RDTs. This review is registered with PROSPERO (CRD42021233124).
Cross-sectional studies comparing the performance of cholera RDTs either to stool culture or PCR.
Individuals with clinically suspected cholera.
Two authors independently extracted data and assessed the quality using Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) criteria.
Eighteen studies were included in the systematic review of which 17 were used for meta-analysis. Crystal VC was the most frequently used RDT (13 studies), followed by Cholkit and Institut Pasteur cholera dipstick (three studies each), SD Bioline (two studies), Artron (one study) and Smart (one study). Using direct testing (n = 12 627 specimens), the bivariate random-effects model yielded a pooled sensitivity and specificity of 91% (95% CI 87%-94%) and 80% (95% CI 74%-84%), respectively. However, through alkaline peptone water (APW) enrichment (n = 3403 specimens), the pooled sensitivity and specificity were 89% (95% CI 79%-95%) and 98% (95% CI 95%-99%), respectively.
Cholera RDTs, especially when enriched with APW, have moderate sensitivity and specificity. Although less useful for clinical management, the current generation of RDTs have clear utility for surveillance efforts if used in a principled manner. Enrichment of stool specimens in APW before using cholera RDTs reduces the possibility of obtaining false-positive results, despite the few cholera cases that go undetected. It is noteworthy that APW-enriched cholera RDTs are not necessarily rapid tests, and are not listed in the Global Task Force on Cholera Control/WHO target product profile.
霍乱是由霍乱弧菌 O1 或 O139 引起的急性腹泻病。霍乱快速诊断检测（RDT）广泛用于筛查霍乱病例。然而，其准确性尚未得到系统评价。
评估霍乱 RDT 的诊断准确性。
系统评价和荟萃分析。
通过 Medline、EMBASE 和 Web of science 检索至 2020 年 11 月；纳入研究的参考文献和一份霍乱 RDT 技术指南。本综述已在 PROSPERO（CRD42021233124）上注册。
比较霍乱 RDT 与粪便培养或 PCR 性能的横断面研究。
临床疑似霍乱的个体。
两名作者独立提取数据，并使用 QUADAS-2 标准评估质量。
系统综述纳入了 18 项研究，其中 17 项用于荟萃分析。Crystal VC 是最常用的 RDT（13 项研究），其次是 Cholkit 和巴斯德霍乱试纸（各 3 项研究）、SD Bioline（2 项研究）、Artron（1 项研究）和 Smart（1 项研究）。使用直接检测（n=12627 份标本），双变量随机效应模型得出的合并敏感性和特异性分别为 91%（95%CI 87%-94%）和 80%（95%CI 74%-84%）。然而，通过碱性蛋白胨水（APW）富集（n=3403 份标本），合并敏感性和特异性分别为 89%（95%CI 79%-95%）和 98%（95%CI 95%-99%）。
霍乱 RDT，特别是经 APW 富集后，具有中等的敏感性和特异性。虽然对临床管理的帮助不大，但如果使用得当，目前这一代 RDT 对监测工作具有明确的用途。在使用霍乱 RDT 之前，用 APW 对粪便标本进行富集，可以减少获得假阳性结果的可能性，尽管有少数霍乱病例未被检出。值得注意的是，APW 富集的霍乱 RDT 不一定是快速检测，也未列入全球霍乱控制工作队/世卫组织目标产品概况。
