Human Papilloma Virus Assays Evaluated for Clinical Performance

Two molecular assays for the detection of human papilloma virus (HPV) DNA were evaluated as screening tools in a clinical setting and a genotyping assay was used for confirmation.

The CLART assay uses biotinylated primers that amplify a fragment within the HPV L1 region. The Hybrid Capture 2 (HC2) test is a sandwich capture molecular hybridization assay that uses a signal amplification detection method based on chemiluminescence. Discrepancies between the tests were checked with the PapilloCheck genotyping assay, which uses a multiplex polymerase chain reaction (PCR) that amplifies a 350 bp fragment of the E1 gene of HPV.

In a study carried out at the Portuguese National Institute of Health, (Lisbon, Portugal), investigators tested 425 archived samples from women with a high risk for HPV (HR-HPV). DNA was extracted from all the samples and tested with both CLART Human Papillomavirus 2 assay (Genomica; Madrid, Spain), which detects and genotypes 35 HPV types (20 HR-HPV and 15 low-risk-HPV), in single or multiple infections and the HC2 assay (Qiagen, Hilden, Germany). For results that were not in concordance, the samples were rechecked with PapilloCheck HPV genotyping system (Greiner Bio-One; Frickenhausen, Germany).

Both the CLART-13 HR-HPV and the HC2 assays showed an identical clinical performance, with a clinical sensitivity of 96%. HR-HPV positivity rates were similar by both tests CLART-13 HR-HPV: 63.1%; CLART-17 HR-HPV: 64.7%; HC2: 64.5%. The clinical specificity of CLART-13 HR-HPV was 73.6% for cervical intraepithelial neoplasia grade 2 or worse, which was comparable to the HC2 clinical specificity of 71.4%.

The authors concluded that the CLART Human Papillomavirus 2 assay showed an excellent performance, very similar to that of the HC2 test, which has a defined clinically cut-off. The CLART assay was efficient, sensitive, and reproducible and 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.

The study was published on December 22, 2010, in the Journal of Medical Virology.

Related Links:
Portugal National Institute of Health
Genomica
Qiagen
Greiner Bio-One