Clinical performance of the CLART human papillomavirus 2 assay compared with the hybrid capture 2 test

Persistent infection by high-risk human papillomavirus (HR-HPV) is a cause of cervical cancer. The use of HPV detection in cervical screening programs may improve the ability to identify women at risk of cervical cancer. Therefore, the development of appropriate methods for the detection of HR-HPV is essential. The aim of this study was to evaluate the clinical performance of the CLART Human Papillomavirus 2 assay (CLART) in comparison with the Hybrid Capture 2 test (HC2), using a clinical cut-off of cervical intraepithelial neoplasia grade 2 or worse. Discrepant results were analyzed further by the PapilloCheck HPV genotyping system. In the 425 studied women, HR-HPV positivity rates were similar by both tests (CLART-13 HR-HPV: 63.1%; CLART-17 HR-HPV: 64.7%; HC2: 64.5%). Agreement between CLART-13 HR-HPV (κ = 0.969; concordance level 98.6%), CLART-17 HR-HPV (κ = 0.974; concordance level 98.8%), and HC2 were very good. When 13 HR-HPV types were considered, the two tests showed a clinical sensitivity of 96% (95% CI: 92.6-97.9). The clinical specificity of CLART-13 HR-HPV was 73.6% (95% CI: 66.7-79.5) for cervical intraepithelial neoplasia grade 2 or worse, which was comparable to HC2 (71.4%; 95% CI: 64.3-77.5). When all 17 HR-HPV types were considered, CLART showed a clinical sensitivity of 96.9% (95% CI: 93.8-98.5) and a clinical specificity of 71.9% (95% CI: 64.9-78.0). In conclusion, the CLART assay is efficient, sensitive, reproducible, and has a similar performance to HC2 for cervical intraepithelial neoplasia grade 2 or worse. Furthermore, this assay has the advantage of detecting and genotyping 35 HPV types by a single test, which can provide additional information on the predictive value of infection with HR-HPV.