Risk assessment of self-sampling HPV tests based on PCR, signal amplification to guide the appropriate screening intervals: A prospective study in China

Abstract

ObjectiveWe assessed the longitudinal risk of developing cervical intraepithelial neoplasia (CINs) with self-sampling human papillomavirus (HPV) tests, based on polymerase chain reaction (PCR) and signal amplification (careHPV), to explore the appropriate intervals for cervical cancer screening. MethodsA prospective study was conducted in China during 2017–2020. Participants were invited for PCR and careHPV tests with self-samples at baseline. Women positive in either HPV test underwent colposcopy and biopsy if necessary. Women with baseline CIN grade one (CIN1) or less were followed up over 3 years. The absolute risk was assessed by the immediate risk (IR) and cumulative risk (CR), and the relative risk was assessed by the hazard ratio (HR) with a 95% confidence interval (CI). ResultsA total of 8,126 women were included in the final analysis. Women positive for the PCR HPV test had comparable IRs of CIN2+ and CIN3+ to those positive on the careHPV test. With triage by HPV genotyping, women with HPV 16/18 infection had the highest IRs of CIN2+ (21.15%) and CIN3+ (9.67%). For CR, women negative for PCR HPV test had a lower risk of CIN2+ than that reported in women negative on careHPV test (0.57% versus 0.98%, HR = 0.58, 95% CI: 0.38, 0.87), but no significant difference was found in the CRs of CIN3+ between them (0.25% versus 0.39%, HR = 0.64, 95% CI: 0.34, 1.20). Among women with CIN1 or less at baseline, women who were persistent or recurrent positive on careHPV or PCR HPV test had a higher risk of developing CIN3+ (11.36%-14.59%), compared with women remained HPV negative from baseline throughout follow-up (≤0.28%). ConclusionsRoutine screening with 3-year intervals is acceptable for self-sampling HPV tests based on PCR or careHPV test. Women positive on HPV16/18 triaging at baseline or with CIN1 or less at baseline while being persistent or recurrent positive on careHPV or PCR HPV test during 3-year follow-up require immediate colposcopy or treatment.