BD Onclarity HPV assay now in CAP HPV Surveys

The FDA-approved uses for this assay are as follows: 1) triage of specimens showing atypical squamous cells of undetermined significance (ASC-US) in women 21 years and older; 2) use as an adjunct to cervical cytology (cotesting) in women 30 years and older; 3) first-line primary cervical cancer scre...

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Bibliographic Details
Published inCAP Today Vol. 33; no. 8; p. 44
Main Authors Davey, Diane Davis, Schinstine, Malcolm, Goodrich, Kelly
Format Trade Publication Article
LanguageEnglish
Published Northfield College of American Pathologists 01.08.2019
Subjects
Cellular biology
FDA approval
Human papillomavirus
Laboratories
Medical screening
United States > US
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Summary:The FDA-approved uses for this assay are as follows: 1) triage of specimens showing atypical squamous cells of undetermined significance (ASC-US) in women 21 years and older; 2) use as an adjunct to cervical cytology (cotesting) in women 30 years and older; 3) first-line primary cervical cancer screening in women 25 years and older. Laboratories are evaluated for the ability to detect high-risk HPV types, and those that perform testing on ThinPrep samples can also elect to provide genotyping results to include HPV types 16 and 18; this portion of the assay is for educational use only and the results are not reported to the Centers for Medicare and Medicaid Services. Detection of cervical neoplasia by human papillomavirus testing in an atypical squamous cells-undetermined significance population: results of the Becton Dickinson Onclarity trial.
ISSN:0891-1525