Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples.

ABSTRACT:

Background

The novel BD Onclarity^TM HPV assay (Onclarity) on the BD Viper™ LT system (BD Diagnostics, Sparks, MD), detects E6/E7 DNA from 13 high-risk HPV genotypes and HPV66. We compared the analytical and clinical performance of the Onclarity Assay to that of Hybrid Capture 2 and LINEAR ARRAY using adjudicated histological outcomes from Danish women referred for colposcopy.

Methods

276 women from Copenhagen, Denmark were referred for colposcopy with abnormal cytology and/or a positive HPV test. Two samples for HPV analysis were taken in BD SurePath™ and in the BD cervical brush diluent (CBD) media. ClinicalTrial gov. identifier: NCT01671462, Ethical Approval: H-4-2012-070.

Results

Histology was normal in 84 (31%) women, 70 (26%) had CIN1, 47 (17%) CIN2, a

SUBMITTER: Ejegod DM 

PROVIDER: S-EPMC5886872 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature