The triage value of high-risk human papillomavirus testing and extended genotyping in vaginal self-sampling for cervical cancer screening
Objective To investigate the efficacy of vaginal self-sampling for cervical cancer screening of high-risk human papillomavirus(HR-HPV)in detecting high-grade intraepithelial lesions(HSIL)and triage value for HPV-positive extended typing.Methods This prospective cross-sectional study,conducted from September 2018 to December 2020 across 13 provinces in China,recruited 20 103 women aged 30 to 59 for vaginal self-sampling cervical cancer screening based on internet.The next generation sequencing or fluorescent PCR method were used to detect 14 kinds of HR-HPV.Results Among 20 103 women,the five most common HR-HPV subtypes were HPV 52,HPV 58,HPV 16,HPV 39,and HPV 51.Histological analysis of 2 045 patients revealed the sensitivity,specificity,positive predictive value,negative predictive value of CIN2+were 99.40％,86.85％,5.92％and 99.99％,respectively.In CIN2+,the top 5 HR-HPV were HPV16,HPV33,HPV18,HPV31 and HPV58,respectively.The positive rates of HPV16,HPV18 and other 12 types of HPV were 46.99％(78/166),10.84％(18/166)and 42.17％(70/166),respectively.In CIN1,it was 12.92％(70/542),7.75％(42/542)and 79.34％(430/542),respectively.Detection of CIN2+by HPV16 was the highest,up to 42.7％,followed by HPV 52 and HPV 58.In combined detection,the sensitivity of HPV 16/18 was 55.15％.Combining HPV 16/18/33 yielded a sensitivity of 66.67％and a specificity of 76.54％for CIN2+detection.Although the sensitivity of CIN2+was increased with other 12 HPV subtypes,the specificity was decreased.Conclusions Vaginal self-sampling for HR-HPV detecting proves to be an efficient method for cervical cancer screening.In addition to HPV 16/18,extended genotyping with HPV 16/18/33 serves as a suitable triage protocol,enhancing the screening and triage efficacy in a single test.
cervical cancer screeningself-samplinghigh-risk human papillomavirustriageextended genotyping
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