在中国，男男性行为者的自我采样标本在 HPV 检测方面与临床医生采样标本具有相当的准确性和一致性。

Self-sampled specimens demonstrate comparable accuracy and consistency to clinician-sampled specimens for HPV detection among men who have sex with men in China.

机构信息

University of North Carolina Project-China, Guangzhou, Guangdong, China.

Zhuhai Xutong Voluntary Services Center, Zhuhai, China.

出版信息

Sex Transm Infect. 2023 Mar;99(2):104-109. doi: 10.1136/sextrans-2022-055408. Epub 2022 May 9.

DOI:10.1136/sextrans-2022-055408

PMID:35534231

Abstract

OBJECTIVES

Despite a high risk of human papillomavirus (HPV) infection among men who have sex with men (MSM), few have ever tested. This study aimed to evaluate the feasibility and accuracy of HPV self-sampling among Chinese MSM, with the purpose of measuring the feasibility of self-sampling as an alternative in HPV testing scenarios.

METHODS

Eligible participants were those who were assigned male at birth, aged 18 or above, had sex with men in the past year and had never gotten HPV vaccine. Participants followed the instructions to self-sample and were also clinician-sampled from the same anatomical sites (oral fluid, penis and rectum) in both approaches. All specimens were processed using multiplex PCR assay. The reference standard of an individual with a true positive for HPV is determined via PCR test, regardless of sampling methods. Sensitivity and specificity were calculated for each approach independently and kappa test was used to assess the consistency between the two approaches.

RESULTS

Overall, 211 MSM were recruited at the local clinic from April to October 2020 in Zhuhai, China. The mean age was 31 years old. Only 3% of the participants sought help from healthcare providers during self-sampling. The prevalence of HPV was 49% (103 of 211). Clinician sampling detected 91 of 103 MSM infected with HPV, with a sensitivity of 88.3% (95% CI 80.2 to 93.6) and a specificity of 100.0% (95% CI 95.7 to 100.0). Self-sampling detected 81 of 103 MSM infected with HPV, with a sensitivity of 78.6% (95% CI 69.2 to 85.9) and a specificity of 100.0% (95% CI 95.7 to 100.0). The level of agreement was moderate between clinician sampling and self-sampling (k=0.67).

CONCLUSIONS

Self-sampled HPV testing demonstrated comparable accuracy and consistency to clinician sampling among MSM in China. It holds the potential to complement sexual health services especially among key populations.

摘要

目的

尽管男男性行为者（MSM）感染人乳头瘤病毒（HPV）的风险很高，但很少有人接受过检测。本研究旨在评估 HPV 自我采样在我国 MSM 中的可行性和准确性，旨在衡量自我采样作为 HPV 检测替代方案的可行性。

方法

合格的参与者为出生时被指定为男性、年龄在 18 岁及以上、在过去一年中与男性发生过性行为且从未接种过 HPV 疫苗的人。参与者按照说明进行自我采样，并且在两种方法中，从相同的解剖部位（口腔液、阴茎和直肠）由临床医生进行采样。所有标本均采用多重 PCR 检测法进行处理。个体 HPV 检测结果为阳性的参考标准通过 PCR 检测确定，与采样方法无关。分别计算每种方法的敏感性和特异性，并使用 Kappa 检验评估两种方法之间的一致性。

结果

2020 年 4 月至 10 月，在中国珠海的当地诊所共招募了 211 名 MSM。参与者的平均年龄为 31 岁。在自我采样过程中，只有 3%的参与者向医疗保健提供者寻求帮助。HPV 的流行率为 49%（211 名中有 103 名）。临床医生采样检测到 103 名 MSM 中有 91 名感染 HPV，敏感性为 88.3%（95%CI80.2 至 93.6），特异性为 100.0%（95%CI95.7 至 100.0）。自我采样检测到 103 名 MSM 中有 81 名感染 HPV，敏感性为 78.6%（95%CI69.2 至 85.9），特异性为 100.0%（95%CI95.7 至 100.0）。临床医生采样和自我采样之间的一致性为中度（k=0.67）。