Comparison of hybribio-H13 and hybrid capture 2 human papillomavirus tests for detection of CIN2+ and CIN3+

Abstract

Introduction. Low‐cost, accurate hrHPV tests are needed for cervical cancer screening in limited-resource settings.
Objective. To carried out to compare the performance of the low-cost H13 test with HC2 to detect CIN2+ and CIN3+.
Materials and methods. Archived baseline samples tested by HC2 from women aged 20–69 years of the ASCUS-COL trial with biopsy-colposcopy directed diagnosis of CIN2+ (n=143) and CIN3+ (n=51) and 632 women with <CIN2, were retrospectively and blindly tested by H13.
Results. The relative sensitivity of H13 versus HC2 for detecting CIN2+ was 0,89 (90% CI:0,80-0,98; pni 0,66) and for CIN3+ was 0,92 (90% CI: 0,85-0,98; pni 0,35). Relative specificity was 1.19 (90% CI: 1.05-1.33; pni <0.00001). In the analysis restricted to ≥30-year-old-women, the relative sensitivity of H13 for CIN3+ was marginally below unity, (ratio: 0.97, 90% CI 0.95-0.99), and the specificity remained higher than HC2.
Conclusion. H13 was as specific but less sensitive than HC2 for detecting CIN2+ or CIN3+. Considering these results and the young age of the population that was recruited for screening because of ASCUS cytology, we suggest our results warrant the evaluation of H13 for screening of cervical cancer, especially in the screening population.