Hybrid Capture 2 and cobas human papillomavirus assays perform similarly on SurePath samples from women with abnormalities

Abstract

Objective: In two laboratories (Departments of Pathology, Copenhagen University Hospitals of Herlev and Hvidovre), we compared cobas and Hybrid Capture 2 (HC2) human papillomavirus (HPV) assays using SurePath® samples from women with atypical squamous cells of undetermined significance (ASCUS) at ≥30 years and women after treatment of cervical intraepithelial neoplasia (CIN). Methods: Samples from 566 women with ASCUS and 411 women after treatment were routinely tested with HC2 and, thereafter, with cobas. Histological outcomes were retrieved from the Danish Pathology Data Base. We calculated the overall agreement between the assays, and compared their sensitivity and specificity for ≥CIN2. Results: In women with ASCUS, HC2 and cobas testing results were similar in the two laboratories. The overall agreement was 91% (95% CI, 88–93). After CIN treatment, the overall agreement was 87% (95% CI, 82–91) at Herlev and 88% (95% CI, 82–92) at Hvidovre. There were no significant differences in the sensitivity for ≥CIN2 between the two tests [Herlev, 98% (95% CI, 89–100) for HC2 versus 94% (95% CI, 82–99) for cobas; Hvidovre, 97% (95% CI, 83–100) for HC2 versus 100% (95% CI, 88–100) for cobas]. The differences were also not significant for specificity. Conclusions: In women with the studied well-defined clinical indications for HPV testing, cobas and HC2 performed similarly in terms of the detection of HPV and ≥CIN2.