Comparison of Roche cobas test and HC2 test for the detection of high-risk HPV in a population-based study

Abstract

Objective: Roche cobas HPV test was approved by FDA for detecting hr-HPV. The performance of cobas test was compared to Hybrid Capture 2 (HC2) test for the detection of hr-HPV in a population-based study in Hong Kong. Methods: A total of 5459 women were recruited from well-woman clinics. Cervical ThinPrep specimens were collected for cytology assessment and HPV detection by both cobas and HC2 tests. Linear Array (LA) genotyping assay was used as confirmatory test to resolve the discordant results between two tests. Analytical performance and clinical relevance of both tests were determined and compared. Results: The positivity of cobas and HC2 test were found in 395 (7.2%) and 415 (7.6%) samples, respectively. Overall, the absolute agreement of two tests was 93.2% and the Kappa value showed a moderate inter-assay agreement of 0.504. Discordant cases were analyzed by LA test. More hr-HPV genotypes were detected in cobas+/HC2- cases (33.9% vs 7.5%), whereas less hr-HPV genotypes, but more lr-HPV genotypes were found in cobas-/HC2+ (7.9% vs 25.4%) cases. Four hundred and sixteen cases with indications were referred to colposcopy clinic for further evaluation. High-grade CIN and SCC were found in 17 and one case, respectively. The cobas test showed a higher test specificity than HC2 test (68.6% vs 46.2%), though the sensitivity of cobas test was lower than HC2 test (83.3% vs 94.4%). Conclusions: The cobas test demonstrated comparable analytical performance to the HC2 test with less cross-reactivity with lr-HPV genotypes. With increase of specificity, cobas test showed better clinical performance.