The BD onclarity HPV assay on samples collected in surepath medium meets the international guidelines for human papillomavirus test requirements for cervical screening

Ditte Ejegod, Fabio Bottari, Helle Pedersen, Maria Teresa Sandri, Jesper Bonde

Research output: Contribution to journalArticle

Abstract

This study describes a validation of the BD Onclarity HPV (Onclarity) assay using the international guidelines for HPV test requirements for cervical cancer screening of women 30 years old and older using Danish SurePath screening samples. The clinical specificity (0.90, 95% confidence interval [CI]0.88 to 0.91) and sensitivity (0.97, 95% CI0.87 to 1.0) of the Onclarity assay were shown to be not inferior to the reference assay (specificity, 0.90 [95% CI0.88 to 0.92]; sensitivity, 0.98 [95% CI0.91 to 1.0]). The intralaboratory reproducibility of Onclarity was 97%, with a lower confidence bound of 96% (kappa value, 0.93). The interlaboratory agreement was 97%, with a lower confidence bound of 95% (kappa value, 0.92). The BD Onclarity HPV assay fulfills all the international guidelines for a new HPV test to be used in primarily screening. This is the first clinical validation of a new HPV assay using SurePath screening samples, and thus the Onclarity HPV assay is the first HPV assay to hold an international validation for both SurePath and ThinPrep.

Original languageEnglish
Pages (from-to)2267-2272
Number of pages6
JournalJournal of Clinical Microbiology
Volume54
Issue number9
DOIs
Publication statusPublished - Sep 1 2016

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ASJC Scopus subject areas

  • Microbiology (medical)

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