Comparison of Hybribio-H13 and Hybrid Capture 2 Human Papillomavirus tests for detection of CIN2+ and CIN3+

Abstract

RESUMEN: This study was carried out to compare the performance of the low-cost H13 test with HC2 to detect CIN2+ and CIN3+. Archived baseline samples tested by HC2 from women 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. 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 conclusion, H13 was as specific but less sensitive than HC2 for detecting CIN2+ or CIN3+.