Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, 12 Jiangwangmiao Street, Nanjing, 210042, China.
National Center for STD Control, Chinese Center for Disease Control and Prevention, Nanjing, China.
BMC Infect Dis. 2024 Nov 29;24(1):1366. doi: 10.1186/s12879-024-10273-8.
Extragenital Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are prevalent among men who have sex with men (MSM). Self-sampling could potentially eliminate barriers to extragenital CT/NG testing for MSM that are hard to reach, who refuse to go for clinician-based testing, or who decline an examination. However, the required evidence to determine whether self-collected specimens are as accurate as clinician-taken specimens in terms of CT/NG diagnostic accuracy was limited in low and middle income countries. We therefore compared self-collected rectal and pharyngeal specimens with clinician-taken specimens for diagnostic accuracy among MSM in China.
This was a prospective convenience sample from 6 sexually transmitted infection (STI) clinics in China. We randomized the order of self-collected and clinician-taken specimens from the pharynx and rectum, plus first-void urine, for CT/NG detection. Self-sampling performance was compared with clinician-sampling as to agreement, sensitivity, and specificity. The acceptability of self-sampling was evaluated by questionnaire.
Among the 325 participants, prevalences of rectal CT and NG infections were 13.6% and 5.2% and pharyngeal CT and NG prevalences were 1.5% and 2.8%, respectively. The agreements between the CT tests with the self-collected and clinician-taken specimens were 98.8% (κ = 0.95, 95% CI 0.89-1.00) for rectal site and 99.4% (κ = 0.83, 95% CI 0.60-1.00) for pharyngeal site; and the agreements between NG tests were 99.4% (κ = 0.94, 95% CI 0.86-1.00) for rectal site and 98.2% (κ = 0.72, 95% CI 0.50-0.93) for pharyngeal site. The sensitivity and specificity of self-collected swabs was as follows: rectal CT: 93.0% and 99.6%; pharyngeal CT: 100.0% and 99.4%; rectal NG: 100.0% and 99.4%; pharyngeal NG: 88.9% and 98.4%. Self-collection was highly acceptable, showing that 62.0% MSM preferred self-sampling over clinician-sampling; 90.2% would use self-sampling for detection of CT and NG again.
Extragenital screening for CT and NG should be recommended as part of STI services to MSM population. Self-collection of rectal and pharyngeal specimens had good performance for CT and NG tests and acceptability to the target population.
This trial was registered with the Chinese Clinical Trial Registry, ChiCTR2300073473. Registered 12/07/2023.
生殖道外沙眼衣原体（CT）和淋病奈瑟菌（NG）感染在男男性行为者（MSM）中较为普遍。自我采样可能会消除难以接触、拒绝临床医生检测或拒绝检查的 MSM 进行生殖道外 CT/NG 检测的障碍。然而，在中低收入国家，确定自我采集标本在 CT/NG 诊断准确性方面与临床医生采集标本一样准确所需的证据有限。因此，我们比较了中国 MSM 中自我采集的直肠和咽部标本与临床医生采集的标本在诊断准确性方面的差异。
这是中国 6 家性传播感染（STI）诊所的前瞻性便利样本。我们随机安排了从直肠和咽部采集的自我采集和临床采集标本，以及首次排空尿液，用于 CT/NG 检测。通过问卷调查评估自我采样的可接受性。
在 325 名参与者中，直肠 CT 和 NG 感染的流行率分别为 13.6%和 5.2%，咽部 CT 和 NG 感染的流行率分别为 1.5%和 2.8%。自我采集和临床采集标本 CT 检测的一致性分别为直肠部位 98.8%（κ=0.95，95%CI 0.89-1.00）和咽部部位 99.4%（κ=0.83，95%CI 0.60-1.00）；NG 检测的一致性分别为直肠部位 99.4%（κ=0.94，95%CI 0.86-1.00）和咽部部位 98.2%（κ=0.72，95%CI 0.50-0.93）。自我采集拭子的灵敏度和特异性如下：直肠 CT：93.0%和 99.6%；咽 CT：100.0%和 99.4%；直肠 NG：100.0%和 99.4%；咽 NG：88.9%和 98.4%。自我采集非常受欢迎，62.0%的 MSM 更喜欢自我采样而不是临床医生采样；90.2%的人会再次使用自我采样进行 CT 和 NG 检测。
应推荐对 MSM 人群进行生殖道外 CT 和 NG 筛查，作为性传播感染服务的一部分。直肠和咽部标本的自我采集对 CT 和 NG 检测具有良好的性能，并且对目标人群具有可接受性。
本试验在中国临床试验注册中心注册，注册号 ChiCTR2300073473。注册于 2023 年 12 月 7 日。
