CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Diane Davis Davey, MD
Malcolm Schinstine, MD, PhD
Kelly Goodrich, CT(ASCP)
August 2019—The BD Onclarity HPV assay is a human papillomavirus test approved by the Food and Drug Administration on Feb. 12, 2018. The assay is a qualitative test for detection of HPV in cervical specimens collected either with a broom or endocervical brush/spatula combination and placed in a BD SurePath liquid-based cytology vial. The assay is not approved for use with ThinPrep collection media (PreservCyt). The Onclarity HPV assay targets E6/E7 DNA oncogenes using the BD Viper LT system. The assay detects target DNA of 14 high-risk HPV types by use of PCR and nucleic acid hybridization. The assay specifically identifies HPV types 16, 18, and 45 separately while concurrently detecting the other high-risk HPV types (31, 33, 35, 39, 51, 52, 56, 58, 59, 66, and 68). Other genotyping data are also available and additional processing steps are not necessary.