CINtec PLUS and cobas HPV testing for triaging Canadian women referred to colposcopy with a history of low-grade squamous intraepithelial lesion: Baseline findings

Abstract

Objective and methods: CINtec PLUS and cobas HPV tests were assessed for triaging women referred to colposcopy with a history of LSIL cytology. Both tests were performed at baseline using ThinPrep cervical specimens and biopsy confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) served as the clinical endpoint.

Results: In all ages, (19-76 years, n = 600), 44.3% (266/600) tested CINtec PLUS positive vs. 55.2% (331/600) HPV positive (p = 0.000). Based on 224 having biopsies, sensitivity to detect CIN2+ (n = 54) was 81.5% (44/54) for CINtec PLUS vs. 94.4% (51/54) for HPV testing (p = 0.039); specificities were, 52.4% (89/170) vs. 44.1% (75/170), respectively (p = 0.129). In women ≥30 years (n = 386), 41.2% (159/386) tested CINtec PLUS positive vs. 50.8% (196/386) HPV positive (p = 0.008). Based on 135 having biopsies, sensitivity to detect CIN2+ (n = 24) was 95.8% (23/24) for both CINtec PLUS and HPV tests; specificities were, 55.0% (61/111) vs. 50.5% (56/111), respectively (p = 0.503).

Conclusions: For women referred to colposcopy with a history of LSIL cytology, CINtec PLUS or cobas HPV test could serve as a predictor of CIN2+ with high sensitivity, particularly in women ≥30 years. Either test can significantly reduce the number of women requiring further investigations and follow up in colposcopy clinics.

Keywords: CINtec PLUS test; Human papillomavirus (HPV) triage; Low-grade squamous intraepithelial lesion (LSIL) triage; cobas HPV test; p16/Ki-67 dual-stain cytology.