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

Abstract

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.

HPV prevalence and genotype distribution in a population-based split-sample study of well-screened women using CLART HPV2 Human Papillomavirus genotype microarray system

“…This was similar to the reproducibility evaluated in the Horizon study of two other newly available commercial assays, Roche’s cobas [19] and Hologic/Gen-Probe’s APTIMA [18]. In a small Portuguese study of CLART (n = 75), 99% of archived ThinPrep samples were reproducible [12]. The proportion of positive samples was not reported from that study.…”

Prevalence of Human Papillomavirus Infection in Women in Portugal

“…This assay amplifies a fragment of 450 bp in the L1 region, which allows the identification of The clinical sensitivity and specificity of this assay were 96.9% and 71.9%, respectively. 11 Results from cytology and HPV genotyping were sent directly to the investigator of each center, who communicated the results to study participants.…”

HPV Direct Flow CHIP: A new human papillomavirus genotyping method based on direct PCR from crude-cell extracts

“…Other systems are based on L1 amplification followed by reverse dot/line blot hybridization to type-specific probes, such as INNO-LiPA (Innogenetics NV, Gent, Belgium), which uses SPF10 primers and identifies 28 genotypes (Kleter et al, 1999). PGMY primers are also included in the L1 region and different assays based on these are available, including CLART HPV2 (Genomica, Madrid, Spain), which identifies 35 genotypes (Pista et al, 2011), and the Linear Array (LA) HPV Genotyping Test (Roche Molecular Systems, Alameda, CA) which detects 37 genotypes (Castle et al, 2008).…”