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Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples
Ditte Møller Ejegod1, Jette Junge1, Maria Franzmann1
1Copenhagen University Hospital, Department of Pathology, Hvidovre, Denmark.
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
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.
