Analysis of 1500 women 25 years and older screened with 15 high-risk Human papillomavirus (hrHPV) genotyping test, and performance of various triage strategies of hrHPV positive women

This prospective clinical study evaluated various cervical cancer screening algorithms’ performance following a positive high-risk HPV (hrHPV) screening result. A total of 1500 women living with HIV (WLWH) and HIV-negative women in the ratio of 1:1 and 25 years and older, were enrolled into the study. All women underwent primary cervical cancer screening with the AmpFire Multiplex hrHPV DNA assay using self-collected swabs. Women testing positive for the15 hrHPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68) and an additional 10% testing negative for hrHPV were called back for visual evaluation (VIA and colposcopy). The treatment decisions were based on colposcopy findings. Women with a visual lesion received treatment with loop electrosurgical excision procedure (LEEP), and those with no lesion or whose examination was inadequate received a biopsy or an endocervical curettage to ensure all women had a histological endpoint. The primary endpoint was cervical intraepithelial neoplasia grade 2 or worse (CIN 2+). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of hrHPV followed by triage with VIA, colposcopy, and three partial genotyping protocols (HPV 16/18; HPV 16/18/45; and HPV 16/18/31/33/35/45/52/58) were calculated as screening algorithms.