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  • Title: Comparison Study of BD Onclarity HPV With digene HC2 High-Risk HPV DNA Test and Roche Cobas 4800 HPV for Detecting High-Risk Human Papillomavirus in Japan.
    Author: Nakamura M, Nakade K, Orisaka S, Iwadare J, Mizumoto Y, Fujiwara H.
    Journal: Am J Clin Pathol; 2019 Feb 04; 151(3):263-269. PubMed ID: 30260388.
    Abstract:
    OBJECTIVES: To evaluate the clinical performance of novel detection kits for 14 high-risk human papillomavirus (hrHPV) types with the BD Onclarity HPV Assay (Onclarity; Becton Dickinson, Sparks, MD). METHODS: Two cervical specimens from 144 women were obtained and placed in BD SurePath Collection Vials. The first specimen was used for cervical cytology and digene HC2 High-Risk HPV DNA Test (HC2; Qiagen, Germantown, MD), and the second specimen was used for Onclarity and Roche Cobas 4800 HPV (Cobas; Roche Molecular Systems, Pleasanton, CA). Other HPV genotyping kits were used for specimens identified as positive by Onclarity or Cobas. RESULTS: Fifty-three of 144 specimens were positive by Onclarity. Overall agreement rates of Onclarity with HC2 and Cobas were 93.8% and 94.4%, respectively. The sensitivity and specificity for cervical intraepithelial neoplasia type 2 or higher of Onclarity were similar to HC2 and Cobas. CONCLUSION: The results showed that the clinical performance of Onclarity was equivalent to HC2 and Cobas.
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