Clinical experience with the Cervista HPV HR assay: correlation of cytology and HPV status from 56,501 specimens.

Testing for high-risk (HR) human papillomavirus (HPV) is a key component of current recommendations for cervical cancer screening. Herein is described our clinical experience using Cervista HPV HR, a testing platform recently approved by the US Food and Drug Administration for clinical use. Using data from a high-volume commercial laboratory, a retrospective analysis of cytologic and Cervista HPV HR test results from 56,501 samples was performed, and an indirect comparison was made with previous experience with 53,008 samples tested using the Hybrid Capture 2 platform. Of samples analyzed using Cervista HPV HR, 1.5% were of insufficient volume for testing and 1.1% yielded an insufficient signal from the internal control to be reported. In samples with a cytological interpretation of atypical squamous cells of undetermined significance, 48.5% (95% confidence interval [CI], 47.5 to 49.5) tested positive using Cervista HPV HR, compared with 59.4% (95% CI, 58.3 to 60.5) of samples using Hybrid Capture 2. Of samples from women aged 30 years or older with a negative cytological interpretation, 5.8% (95% CI, 5.6 to 6.1) tested positive using Cervista HPV HR, compared with 5.5% (95% CI, 5.3 to 5.7) of samples using Hybrid Capture 2. When stratified by five-year age groups between 30 and 65 years, positivity rates for high-risk human papillomavirus were similar in the Cervista HPV HR and Hybrid Capture 2 populations, and were consistent with expectations established by the literature.