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

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.

KEYWORDS:

• Pre-analytical automation
• BD Onclarity
• BD COR
• BD Viper LT
• BD SurePath
• PreservCyt
• BD Cervical Brush Diluent

Acknowledgments

The authors would like to thank Devin S. Gary, PhD (Becton, Dickinson and Company, BD Life Sciences – Diagnostic Solutions), for his input on the content of this manuscript and editorial assistance. The authors also thank Aojun Li and Indrias Berhane (Becton, Dickinson and Company, BD Life Sciences – Diagnostic Systems Solutions) for their statistical support. The authors also thank the BD employees who worked to establish the data presented in this report. The individuals acknowledged here have no additional funding or additional compensation to disclose.

Declaration of interest

K Eckert, M Van Sickler, JA Price, E Gutierrez, AA Rucki, M Lizzi, DM Wolfe, JM Harris, SM Gregory, and L Vaughan are employees of Becton, Dickinson and Company, the study sponsor. All non-BD employees received research funding as part of this study. SN Taylor reports receiving grants to her institution from Becton Dickinson, Hologic, Cepheid, binx, Rheonix, Roche, and Abbott Molecular. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

One peer reviewer has worked on trials which involve independent evaluation of HPV assays on cervical and vaginal self-samples. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Notes

Abbreviations: PPA, positive percent agreement; NPA, negative percent agreement; OPA, overall percent agreement; CI, confidence interval; CBD, Cervical Brush Diluent

Additional information

Funding

This work was supported by Becton, Dickinson and Company, BD Life Sciences – Integrated Diagnostic Solutions.