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High-risk human papillomavirus (HPV) detection in formalin-fixed paraffin-embedded cervical tissues: performances of Aptima HPV assay and Beckton Dickinson (BD) Onclarity assay
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  • Published on:
    Comment on Kir et al article: "High-risk human papillomavirus (HPV) detection in formalin-fixed paraffin-embedded cervical tissues: performances of Aptima HPV assay and Beckton Dickinson (BD) Onclarity assay"
    • Laurence M Vaughan, Director, Scientific Affairs BD Life Sciences, Integrated Diagnostic Solutions
    • Other Contributors:
      • Jeffrey A Andrews, Global Vice-President, Medical Affairs
      • Molly Broache, Senior Global Medical Science Liaison, Scientific Affairs

    Dear Editor,

    We read with interest the recently published manuscript by Kir et al. entitled “High-risk human papillomavirus (HPV) detection in formalin-fixed paraffin-embedded cervical tissues: performances of Aptima HPV assay and Becton Dickinson (BD) Onclarity assay” [1]. The study evaluates the off-label use of commercial HPV assays on formalin-fixed paraffin-embedded (FFPE) specimens. The authors detail the performance of the Hologic Aptima RNA test and the BD Onclarity DNA test in a study of 189 cases (46 SCC, 107 HSIL and 36 benign/normal). They report that, while the specificity and positive predictive value (PPV) were 100% for both assays, the Aptima assay was more sensitive, detecting 99.4% (95% CI 96.46% to 99.98%) of CIN2+ cases, versus the BD Onclarity assay with a sensitivity of 75.9% (95% CI 65.27% to 84.62%) [1]. The authors conclude that “both assays are reliable methods for high-risk HPV detection and genotype determination in FFPE specimens” and that the “Aptima assay has the advantage of higher sensitivity”.

    We believe that there are a number of deficiencies in the study design (not addressed in the discussion section) which call into question the validity of the conclusions. Firstly, this is not a split sample study, nor a true head to head comparison since the samples were not randomly assigned to each assay for testing. All 189 cases were first tested with the Aptima assay and only approximately half (n = 97) were subsequently tes...

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    Conflict of Interest:
    The authors are employees of Becton Dickinson and Company which sells and distributes the BD Onclarity HPV Assay which is one of the assays used in the study by Kir et al.