Institute for Global Health and Development, Queen Margaret University, Edinburgh, Scotland.
London School of Hygiene and Tropical Medicine, London, United Kingdom.
PLoS One. 2022 Jul 6;17(7):e0270860. doi: 10.1371/journal.pone.0270860. eCollection 2022.
Cholera continues to pose a problem for low-resource, fragile and humanitarian contexts. Evidence suggests that 2.86 million cholera cases and 95,000 deaths due to cholera are reported annually. Without quick and effective diagnosis and treatment, case-fatality may be 50%. In line with the priorities of the Global Task Force on Cholera Control, we undertook a systematic review and meta-analysis of diagnostic test accuracy and other test characteristics of current tests for cholera detection in stool and water.
We searched 11 bibliographic and grey literature databases. Data was extracted on test sensitivity, specificity and other product information. Meta-analyses of sensitivity and specificity were conducted for tests reported in three or more studies. Where fewer studies reported a test, estimates were summarised through narrative synthesis. Risk of Bias was assessed using QUADAS-2.
Searches identified 6,637 records; 41 studies reporting on 28 tests were included. Twenty-two tests had both sensitivities and specificities reported above 95% by at least one study, but there was, overall, wide variation in reported diagnostic accuracy across studies. For the three tests where meta-analyses were possible the highest sensitivity meta-estimate was found in the Cholera Screen test (98.6%, CI: 94.7%-99.7%) and the highest specificity meta-estimate in the Crystal VC on enriched samples (98.3%, CI: 92.8%-99.6%). There was a general lack of evidence regarding field use of tests, but where presented this indicated trends for lower diagnostic accuracy in field settings, with lesser-trained staff, and without the additional process of sample enrichment. Where reported, mean test turnaround times ranged from over 50% to 130% longer than manufacturer's specification. Most studies had a low to unclear risk of bias.
Currently available Rapid Diagnostic Tests can potentially provide high diagnostic and detection capability for cholera. However, stronger evidence is required regarding the conditions required to secure these levels of accuracy in field use, particularly in low-resource settings.
PROSPERO (CRD42016048428).
霍乱仍然是资源匮乏、脆弱和人道主义环境面临的一个问题。有证据表明，每年报告有 286 万例霍乱病例和 9.5 万例霍乱死亡。如果没有快速有效的诊断和治疗，病死率可能达到 50%。根据全球霍乱控制工作队的优先事项，我们对当前用于粪便和水中霍乱检测的诊断测试准确性和其他测试特性进行了系统评价和荟萃分析。
我们搜索了 11 个文献和灰色文献数据库。提取了关于测试敏感性、特异性和其他产品信息的数据。对报告了 3 项或更多研究的测试进行了敏感性和特异性的荟萃分析。对于报告较少研究的测试，通过叙述性综合报告了估计值。使用 QUADAS-2 评估偏倚风险。
搜索确定了 6637 条记录；纳入了 41 项研究报告的 28 项测试。22 项测试的敏感性和特异性至少有一项研究报告在 95%以上，但总体而言，研究之间的诊断准确性报告差异很大。对于可以进行荟萃分析的三种测试，Cholera Screen 测试的最高敏感性荟萃估计值为 98.6%（94.7%-99.7%），Crystal VC 在富集样本上的最高特异性荟萃估计值为 98.3%（92.8%-99.6%）。关于现场使用测试的证据普遍缺乏，但在提供的证据中表明，在野外环境中，在训练有素的人员较少的情况下，并且没有样本富集的额外过程，诊断准确性较低的趋势。报告的平均测试周转时间比制造商的规格长 50%以上至 130%不等。大多数研究的偏倚风险较低或不清楚。
目前可用的快速诊断测试可能为霍乱提供高诊断和检测能力。然而，需要有更强的证据来证明在野外使用中获得这些准确性水平所需的条件，特别是在资源匮乏的环境中。
PROSPERO（CRD42016048428）。
