Adjunct screening of cervical or vaginal samples using careHPV testing with Pap and aided visual inspection for detecting high-grade cervical intraepithelial neoplasia.

OBJECTIVE: To evaluate the performance of careHPV DNA testing for human papillomavirus (HPV) on cervical and vaginal samples (CHPV and VHPV respectively) in adjunct screening together with visual inspection of the cervix by acetic acid (VIA) or Papanicolaou (Pap) tests in the detection of high-grade cervical intraepithelial neoplasia (CIN).

SUBJECTS AND METHODS: A cross-sectional study examined 4658 women 30-59 years of age by performing screening tests for HPV using careHPV on cervical and vaginal samples together with Pap and VIA. The CHPV and VHPV test results were presented as a ratio of viral load expressed in relative light units (RLUs) to the mean RLU from a positive control set at 1 pg/mL cut-off (CO). Performances of various pairs of screening tests in parallel and sequential settings were computed through the detection rates of CIN, percentages of unnecessary colposcopic referrals of screen positives, and compared with stand-alone tests.

RESULTS: The screening positivity of CHPV, VHPV, Pap and VIA ranged from 2.4% to 5.5%. The highest sensitivity (72%) was observed for the combination of CHPV and VIA in parallel, followed by 65.6% for CHPV and Pap, and 59% for all other combinations (VHPV and Pap, VHPV and VIA, and VIA and Pap). The percentage of unnecessary colposcopic referrals in the parallel setting of CINII+ detection ranged from 2.8% to 6.0%. Sequential testing of CHPV or VHPV with other tests yielded very low sensitivities with a reduction in unnecessary colposcopic referrals.

CONCLUSION: Cervical careHPV testing (CHPV) in parallel with VIA was the option that performed best in the detection of high-grade CIN and could be a feasible option for low-resource countries (LRCs).