Evaluation of the Onclarity HPV assay on the high-throughput COR system. (4th March 2021)

• Record Type: Journal Article
• Authors: Taylor, Stephanie N.; Eckert, Karen; Rucki, Agnieszka A.; VanSickler, Michael; Price, James A.; Gutierrez, Erin; Lizzi, Mike; Cammarata, Catherine L.; Von Bredow, Benjamin; Wolfe, David M.; Harris, James M.; Gregory, Sean M.; Greene, Wallace H.; Vaughan, Laurence M.
• Is Part Of: Expert review of molecular diagnostics. Volume 21:Number 3(2021)
• Page Start: 333
• Page End: 342
• Publication Date: 2021-03-04
• Subjects: Pre-analytical automation -- BD Onclarity -- BD COR -- BD Viper LT -- BD SurePath -- PreservCyt -- BD Cervical Brush Diluent; Molecular diagnosis -- Periodicals; 616.0758205
• DOI: 10.1080/14737159.2021.1894132
• Languages: English
• ISSNs: 1473-7159

Abstract

ABSTRACT: Background : Here we compare the performance of the high-throughput BD COR System (COR) to the Viper LT System (Viper) using the BD Onclarity HPV assay. Research Design and Methods : Remnant clinical specimens, contrived specimens in SurePath (BD) and PreservCyt (Hologic) media, and prospective clinical specimens in BD Cervical Brush Diluent (CBD) were tested. Outcomes included intra-laboratory agreement of Onclarity results on COR and inter-system agreement between COR and Viper. Results : Onclarity reproducibility on COR resulted in standard deviation and correlation of variation of Ct values ranging from 0.14 to 1.98 and 0.49% to 2.15%, respectively, for contrived specimens, and 0.9–3.08 and 2.89–9.21%, respectively, for clinical specimens. In the COR and Viper clinical agreement study, OPA for Onclarity ranged from 97.1%-98.9%, depending on the collection media type. PPA values for pooled, HPV(+) specimens at low positive (C95 ), and moderate positive (3XC95 ) target concentrations were ≥95.0% and 100%, respectively; PPA values associated with HPV 16, 18, 31, 45, 33/58, 52, 35/39/68, 51, and 56/59/66, individually, ranged from 93.8%-100%. Conclusions : Onclarity performance on COR is equivalent to Viper, and is accurate and reproducible for detection of all high-risk HPV genotypes, with a throughput of 330 results from a single 8-hour shift.