Analytical and Clinical Sample Performance Characteristics of the Onclarity Assay for the Detection of Human Papillomavirus.

Objective: To determine result reproducibility, and performance of the BD Onclarity™ HPV Assay (Onclarity) on the BD Viper™ LT platform using both contrived and clinical specimens.Methods: Reproducibility was assessed in BD SurePath™ LBC media (SurePath) using contrived panels (HPV16+, 18+, or 45+) or clinical specimens (HPV16+, 18+, 31+, 33/58+, 45+, 52+, or HPV-). In addition, specimens from 3,879 individuals from the Onclarity trial were aliquoted prior to or following cytology processing and tested for HPV. Finally, specimens were collected using either the Cervex-brush® or Cytobrush® (or Cytobrush/spatula) for comparison of HPV results.Results: Contrived specimens showed >95% concordance with expected results and pooled clinical specimens had standard deviation and coefficient of variation values ranging from 0.87 to 1.86 and 2.9% to 5.6%, respectively. For pre-cytology and post-cytology aliquot analyses, specimens showed >98.0% overall agreement and mean differences in Ct score for HPV ranging from -0.07 to 0.31. Positivity rates were close between the Cervex-brush and Cytobrush/spatula for all age groups tested.Conclusions: Onclarity results are reproducible and reliable, regardless of sample collection before or after the cytology aliquot. Onclarity performs well regardless of the method of specimen collection (Cervex-brush or Cytobrush/spatula) for cervical cancer screening.