Evaluation of the Onclarity HPV assay on the high-throughput COR system
| Autor: | Stephanie N. Taylor, James M. Harris, Sean M. Gregory, Wallace H. Greene, Agnieszka A. Rucki, Benjamin von Bredow, Catherine L. Cammarata, Michael T. Vansickler, James A. Price, Karen Eckert, David M. Wolfe, Erin C. Gutierrez, Laurence M. Vaughan, Mike Lizzi |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Hpv genotypes Reproducibility VIPeR business.industry Papillomavirus Infections Reproducibility of Results Uterine Cervical Neoplasms Sensitivity and Specificity Pathology and Forensic Medicine 03 medical and health sciences 030104 developmental biology 0302 clinical medicine 030220 oncology & carcinogenesis Genetics Molecular Medicine Medicine Humans Female Prospective Studies Nuclear medicine business Molecular Biology Papillomaviridae |
| Zdroj: | Expert review of molecular diagnostics. 21(3) |
| ISSN: | 1744-8352 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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