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尼日利亚拉各斯的女性中,自我采集样本与医护采集样本进行人乳头瘤病毒检测的比较研究。

Self-collected versus medic-collected sampling for human papillomavirus testing among women in Lagos, Nigeria: a comparative study.

机构信息

Center for Global Public Health, Chinese Centre for Disease Control and Prevention, 155 Changbai Road, Changping District, Beijing, 102206, China.

Department of Clinical Sciences, Nigerian Institute of Medical Research, 6 Edmund Crescent, Yaba, Lagos, Nigeria.

出版信息

BMC Public Health. 2022 Oct 15;22(1):1922. doi: 10.1186/s12889-022-14222-5.

Abstract

OBJECTIVE

To evaluate the feasibility and performance of self-collected vaginal swab samples for HPV screening among women in Lagos, Nigeria.

METHODS

A cross-sectional study was implemented from March to August 2020 among sexually active women. Study participants provided same-day paired vaginal swab samples. Medic-sampling and poster-directed self-sampling methods were used to collect the two samples per participant. A real-time PCR assay detected HPV 16, HPV 18, other-high-risk (OHR) HPV, and the human β-globin gene. The self-collected samples' sensitivity, specificity, and accuracy were determined against the medic-collected samples using the MedCalc Online Diagnostic Calculator.

RESULTS

Of the 213 women aged 16 ~ 63-year-old recruited, 187 (88%) participants had concordant results, while 26 (12%) participants had discordant results. Among the 187 concordant results, 35 (19%) were HPV positive, 150 (80%) participants were HPV negative, and two (1%) were invalid. 18 (69%) out of the 26 discordant samples were invalid. The self-collected sample was invalid for 14 (54%) participants. Two (8%) medic-collected samples were invalid. Compared to the medic-collected sample, the self-collected sample was 89.80% (95% CI: 77.77 ~ 96.60%) sensitive and 98.21% (95% CI: 94.87 ~ 99.63%) specific, with an accuracy of 96.31% (95% CI: 92.87 ~ 98.40%). The mean age for HPV positive and negative participants were 39 and 40, respectively, with an ANOVA p-value of 0.3932. The stratification of HPV infection by the age group was not statistically significant (P > 0.05).

CONCLUSIONS

With high accuracy of 96%, self-collected sampling is adequate when tested with real-time PCR and may increase the uptake of HPV testing. Though more self-collected samples were invalid than medic-collected samples, most likely due to poor collection, they could be identified for repeat testing. Future implementation can avoid this error with improved guidance and awareness.

摘要

目的

评估尼日利亚拉各斯女性使用自我采集阴道拭子样本进行 HPV 筛查的可行性和性能。

方法

2020 年 3 月至 8 月期间,对性活跃女性进行了一项横断面研究。研究参与者提供了当天采集的配对阴道拭子样本。使用 Medic 采样和海报指导的自我采样方法,每位参与者采集两份样本。实时 PCR 检测检测 HPV 16、HPV 18、其他高危型(OHR)HPV 和人类β-球蛋白基因。使用 MedCalc Online Diagnostic Calculator ,根据 Medic 采集样本的结果,确定自我采集样本的敏感性、特异性和准确性。

结果

在招募的 213 名年龄在 16 岁至 63 岁的女性中,187 名(88%)参与者的结果一致,26 名(12%)参与者的结果不一致。在 187 份一致的结果中,35 份(19%)HPV 阳性,150 份(80%)参与者 HPV 阴性,2 份(1%)无效。26 份不一致的结果中,18 份(69%)无效。14 名(54%)自我采集样本无效。2 名(8%) Medic 采集样本无效。与 Medic 采集样本相比,自我采集样本的敏感性为 89.80%(95%CI:77.7796.60%),特异性为 98.21%(95%CI:94.8799.63%),准确性为 96.31%(95%CI:92.87~98.40%)。HPV 阳性和阴性参与者的平均年龄分别为 39 岁和 40 岁,方差分析 p 值为 0.3932。HPV 感染的年龄组分层无统计学意义(P>0.05)。

结论

自我采集样本的准确性高达 96%,使用实时 PCR 检测时足够充分,可能会增加 HPV 检测的接受度。尽管自我采集样本的无效样本比 Medic 采集样本多,但很可能是由于采集不当造成的,可以对这些样本进行重复检测。未来的实施可以通过改进指导和提高认识来避免这种错误。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cba/9569041/6b55fbb86ea9/12889_2022_14222_Fig1_HTML.jpg

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