医学微生物学与诊断

Clinical Validation of the BD Onclarity™ HPV Assay Using a Non-Inferiority Test

Abstract

Ditte Møller Ejegod, Jesper Bonde, Itziar Serrano, Kate S Cuschieri, William A Nussbaumer, Laurence M Vaughan, Amar S Ahmad and Jack Cuzick

The clinical performance of The BD Onclarity™ HPV Assay, a novel type-specific real-time E6/E7-based PCR assay, was evaluated for clinical and analytical performance using the Meijer et al. international guidelines for validation of high-risk HPV tests. Assay performance was found to be similar to the reference method, Hybrid Capture 2 (HC2, QIAGEN) using PreservCyt® Specimens (Hologic®, Inc.). In addition, the fully automated assay was found to have excellent intra- and inter-laboratory reproducibility (98.6% (kappa=0.967) and 98.4% (kappa=0.962), respectively). These data show that the BD Onclarity™ HPV Assay fulfills the clinical validation requirements for a HPV based cervical cancer screening assay (Meijer et al. International journal of cancer 2009; 124: 516-520.).