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.
BMC Public Health. 2022 Oct 15;22(1):1922. doi: 10.1186/s12889-022-14222-5.
To evaluate the feasibility and performance of self-collected vaginal swab samples for HPV screening among women in Lagos, Nigeria.
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.
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).
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.
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。
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。
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)。
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。