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

Papillomavirus Res. 2016 Dec:2:31-37. doi: 10.1016/j.pvr.2016.01.003. Epub 2016 Mar 2.

Abstract

Background: The novel BD OnclarityTM 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, and 68 (25%) had CIN3. The Onclarity assay detected 67 out of 68 (99%) ≥CIN3 and 113/115 (98%) ≥CIN2. The specificities for <CIN2 were 21%, 17%, and 22%, for HC2, Onclarity and LA, respectively.

Conclusion: Overall, the Onclarity HPV assay performed well on SurePath LBC and CBD media, with clinical sensitivity and specificity matching those of HC2 and LA.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adult
  • Aged
  • DNA, Viral / genetics
  • Denmark
  • Female
  • Humans
  • Middle Aged
  • Molecular Diagnostic Techniques / methods*
  • Oncogene Proteins, Viral / genetics
  • Papillomavirus Infections / diagnosis*
  • Sensitivity and Specificity
  • Uterine Cervical Dysplasia / diagnosis*
  • Young Adult

Substances

  • DNA, Viral
  • Oncogene Proteins, Viral

Associated data

  • ClinicalTrials.gov/NCT01671462