Abstract

The World Health Organization has recommended that testing for high-risk human papillomavirus (hrHPV) infection be incorporated into cervical screening programs in all settings worldwide. In many high-burden, low-income countries it will not be feasible to achieve high cervical screening coverage using hrHPV assays that require clinician-collected samples. We conducted the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert® HPV Test. Women aged 30-54 years attending two well woman clinics in Papua New Guinea were invited to participate and provided self-collected vaginal and clinician-collected cervical cytobrush specimens. Both were tested at point-of-care using the Xpert® HPV Test. Women were given their cervical test result the same day. Those with a positive hrHPV test and a positive examination on visual inspection of the cervix with acetic acid were offered same-day cervical cryotherapy. A total of 1005 women were enrolled with 124 (12.3%; 95%CI: 10.3, 14.4) positive for any hrHPV infection. There was 99.4% overall percentage agreement (OPA) between vaginal and cervical tests for HPV-16 (95%CI: 98.9, 99.9); 98.5% OPA for HPV-18/45 (95%CI: 97.7, 99.3); 94.4% OPA for other hrHPV infections (95%CI: 92.9, 95.9); and 93.4% OPA for all hrHPV types combined (95%CI: 91.8, 95.0). Self-collected vaginal specimens had excellent agreement with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert® HPV Test. This approach provides for the first time an opportunity to incorporate point-of-care hrHPV testing into clinical cervical screening algorithms in high-burden, low-income settings.