Evaluation of the Onclarity HPV assay on the high-throughput COR system

Stephanie N. Taylor, Karen Eckert, Agnieszka A. Rucki, Michael VanSickler, James A. Price, Erin Gutierrez, Mike Lizzi, Catherine L. Cammarata, Benjamin Von Bredow, David M. Wolfe, James M. Harris, Sean M. Gregory, Wallace H. Greene, Laurence M. Vaughan

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)333-342
Number of pages10
JournalExpert Review of Molecular Diagnostics
Volume21
Issue number3
DOIs
StatePublished - 2021

All Science Journal Classification (ASJC) codes

  • Pathology and Forensic Medicine
  • Molecular Medicine
  • Molecular Biology
  • Genetics

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