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

Ditte Møller Ejegod, Jette Junge, Maria Franzmann, Benny Kirschner, Fabio Bottari, Mario Sideri, Maria Teresa Sandri, Jesper Bonde

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)31-37
Number of pages7
JournalPapillomavirus Research
Volume2
DOIs
Publication statusPublished - 2016

ASJC Scopus subject areas

  • Infectious Diseases
  • Virology

Fingerprint Dive into the research topics of 'Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples'. Together they form a unique fingerprint.

  • Cite this