在中国男男性行为人群中使用混合泌尿生殖道、肛门直肠和口咽标本检测和的多中心诊断准确性研究。

Using pooled urogenital, anorectal and oropharyngeal specimens to detect and among men who have sex with men in China: a multisite diagnostic accuracy study.

机构信息

Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China.

Department of Outpatient, Wuxi Center for Disease Control and Prevention, Wuxi, China.

出版信息

BMJ Open. 2023 Mar 6;13(3):e069876. doi: 10.1136/bmjopen-2022-069876.

DOI:10.1136/bmjopen-2022-069876

PMID:36878660

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9990619/

Abstract

OBJECTIVES

Screening for (CT) and (NG) at both urogenital and extragenital sites has been recommended in many countries. Testing of the infections using pooled specimens from urogenital and extragenital sites offer the opportunity to shorten the testing time and reduce the testing cost. Ex-ante pooling is placing the original single-site specimens in a tube with transport media, while ex-post pooling is making a pool of the transport media from both anorectal and oropharyngeal specimens and the urine. This study aimed to conduct a multisite performance evaluation of two pool-specimen approaches (ex-ante and ex-post) in detection of CT and NG using the Cobas 4800 platform among men who have sex with men (MSM) in China.

DESIGN

Diagnostic accuracy study.

SETTING, PARTICIPANTS AND OUTCOME MEASURES: Participants were recruited from MSM communities at six cities in China. Two oropharyngeal and anorectal swabs collected by clinical staff and 20 mL first-void urine collected by the participant himself were used for evaluating sensitivity and specificity.

RESULTS

A total of 1311 specimens were collected from 437 participants in six cities. The sensitivities of ex-ante pooling approach as compared with single-specimen approach (reference standard) were 98.7% (95% CI, 92.7% to 100.0%) for detection of CT and 89.7% (95% CI, 75.8% to 97.1%) for NG, and the specificities were 99.5% (95% CI, 98.0% to 99.9%) and 98.7% (95% CI, 97.1% to 99.6%), respectively. The sensitivities of ex-post pooling approach were 98.7% (95% CI, 92.7% to 100.0%) for CT and 100.0% (95% CI, 91.0% to 100.0%) for NG, and the specificities were 100.0% (95% CI, 99.0% to 100.0%) and 100.0% (95% CI, 99.1% to 100.0%), respectively.

CONCLUSIONS

The ex-ante and ex-post pooling approaches show good sensitivity and specificity in detecting urogenital and extragenital CT and/or NG, indicating that these approaches can be used in epidemiological surveillance and clinical management of CT and NG infections, particularly among MSM population.

摘要

目的

在许多国家，建议对泌尿生殖道和非生殖道部位同时进行（CT）和（NG）的筛查。使用泌尿生殖道和非生殖道部位的混合标本进行感染检测，为缩短检测时间和降低检测成本提供了机会。前置混合是将原始的单部位标本放入装有转运介质的管中，而后置混合是将来自肛直肠和口咽标本和尿液的转运介质混合在一起。本研究旨在使用 Cobas 4800 平台在中国男男性接触者（MSM）中对两种混合标本方法（前置和后置）检测 CT 和 NG 的检测性能进行多地点评估。

设计

诊断准确性研究。

地点、参与者和结果测量：参与者从中国六个城市的 MSM 社区招募。由临床工作人员采集两个口咽和肛直肠拭子，由参与者自己采集 20ml 首次排尿的尿液，用于评估敏感性和特异性。

结果

共从六个城市的 437 名参与者中采集了 1311 份标本。与单标本方法（参考标准）相比，前置混合方法的敏感性分别为 CT 98.7%（95%CI，92.7%至 100.0%）和 NG 89.7%（95%CI，75.8%至 97.1%），特异性分别为 99.5%（95%CI，98.0%至 99.9%）和 98.7%（95%CI，97.1%至 99.6%）。后置混合方法的敏感性分别为 CT 98.7%（95%CI，92.7%至 100.0%）和 NG 100.0%（95%CI，91.0%至 100.0%），特异性分别为 100.0%（95%CI，99.0%至 100.0%）和 100.0%（95%CI，99.1%至 100.0%）。