College of Medicine and Dentistry, James Cook University, Townsville, Australia.
Central Clinical School, Monash University, Melbourne, Australia.
BMC Med. 2021 Nov 25;19(1):285. doi: 10.1186/s12916-021-02160-9.
Screening for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) at genital and extragenital sites is needed for most key populations, but molecular diagnostic tests for CT/NG are costly. We aimed to determine the accuracy of pooled samples from multiple anatomic sites from one individual to detect CT/NG using the testing of a single sample from one anatomic site as the reference.
In this systematic review and meta-analysis, we searched five databases for articles published from January 1, 2000, to February 4, 2021. Studies were included if they contained original data describing the diagnostic accuracy of pooled testing compared with single samples, resource use, benefits and harms of pooling, acceptability, and impact on health equity. We present the pooled sensitivities and specificities for CT and NG using a bivariate mixed-effects logistic regression model. The study protocol is registered in PROSPERO, an international database of prospectively registered systematic reviews (CRD42021240793). We used GRADE to evaluate the quality of evidence.
Our search yielded 7814 studies, with 17 eligible studies included in our review. Most studies were conducted in high-income countries (82.6%, 14/17) and focused on men who have sex with men (70.6%, 12/17). Fourteen studies provided 15 estimates for the meta-analysis for CT with data from 5891 individuals. The pooled sensitivity for multisite pooling for CT was 93.1% [95% confidence intervals (CI) 90.5-95.0], I=43.3, and pooled specificity was 99.4% [99.0-99.6], I=52.9. Thirteen studies provided 14 estimates for the meta-analysis for NG with data from 6565 individuals. The pooled sensitivity for multisite pooling for NG was 94.1% [95% CI 90.9-96.3], I=68.4, and pooled specificity was 99.6% [99.1-99.8], I=83.6. Studies report significant cost savings (by two thirds to a third).
Multisite pooled testing is a promising approach to improve testing coverage for CT/NG in resource-constrained settings with a small compromise in sensitivity but with a potential for significant cost savings.
对于大多数重点人群来说,需要对生殖道和非生殖道部位的沙眼衣原体(CT)和淋病奈瑟菌(NG)进行筛查,但 CT/NG 的分子诊断检测费用昂贵。我们旨在确定从一个人多个解剖部位采集的混合样本检测 CT/NG 的准确性,同时将一个解剖部位的单个样本检测作为参考。
在这项系统评价和荟萃分析中,我们从五个数据库中搜索了 2000 年 1 月 1 日至 2021 年 2 月 4 日发表的文章。如果研究包含描述混合检测与单个样本检测相比的诊断准确性、资源利用、混合的益处和危害、可接受性以及对健康公平性的影响的原始数据,我们将纳入研究。我们使用双变量混合效应逻辑回归模型呈现 CT 和 NG 的合并敏感性和特异性。该研究方案已在 PROSPERO(一个国际前瞻性注册系统评价数据库)中注册(CRD42021240793)。我们使用 GRADE 评估证据质量。
我们的搜索结果产生了 7814 项研究,其中有 17 项符合纳入标准。大多数研究(82.6%,14/17)在高收入国家进行,重点是男男性行为者(70.6%,12/17)。14 项研究提供了 15 项关于 CT 的荟萃分析,涉及 5891 人。多部位混合检测 CT 的合并敏感性为 93.1%[95%置信区间(CI)90.5-95.0],I=43.3,合并特异性为 99.4%[99.0-99.6],I=52.9。13 项研究提供了 14 项关于 NG 的荟萃分析,涉及 6565 人。多部位混合检测 NG 的合并敏感性为 94.1%[95% CI 90.9-96.3],I=68.4,合并特异性为 99.6%[99.1-99.8],I=83.6。研究报告称显著节省了成本(节省三分之二到三分之一)。
多部位混合检测是一种很有前景的方法,可以在资源有限的环境中提高 CT/NG 的检测覆盖率,同时对敏感性略有影响,但具有显著的成本节约潜力。