NDLI: Clinical experience with the Cervista HPV HR assay: correlation of cytology and HPV status from 56,501 specimens.

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Clinical experience with the Cervista HPV HR assay: correlation of cytology and HPV status from 56,501 specimens.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Youens, Kenneth E. Hosler, Gregory A. Washington, Paula J. Jenevein, E. Patrick Murphy, Kathleen M.
Description	Country affiliation: United States Author Affiliation: Youens KE ( Department of Pathology, Duke University Medical Center, Durham, North Carolina 27710, USA. kenneth.youens@duke.edu)
Abstract	Testing for high-risk (HR) human papillomavirus (HPV) is a key component of current recommendations for cervical cancer screening. Herein is described our clinical experience using Cervista HPV HR, a testing platform recently approved by the US Food and Drug Administration for clinical use. Using data from a high-volume commercial laboratory, a retrospective analysis of cytologic and Cervista HPV HR test results from 56,501 samples was performed, and an indirect comparison was made with previous experience with 53,008 samples tested using the Hybrid Capture 2 platform. Of samples analyzed using Cervista HPV HR, 1.5% were of insufficient volume for testing and 1.1% yielded an insufficient signal from the internal control to be reported. In samples with a cytological interpretation of atypical squamous cells of undetermined significance, 48.5% (95% confidence interval [CI], 47.5 to 49.5) tested positive using Cervista HPV HR, compared with 59.4% (95% CI, 58.3 to 60.5) of samples using Hybrid Capture 2. Of samples from women aged 30 years or older with a negative cytological interpretation, 5.8% (95% CI, 5.6 to 6.1) tested positive using Cervista HPV HR, compared with 5.5% (95% CI, 5.3 to 5.7) of samples using Hybrid Capture 2. When stratified by five-year age groups between 30 and 65 years, positivity rates for high-risk human papillomavirus were similar in the Cervista HPV HR and Hybrid Capture 2 populations, and were consistent with expectations established by the literature.
File Format	HTM / HTML
ISSN	15251578
e-ISSN	19437811
DOI	10.1016/j.jmoldx.2010.11.016
Journal	The Journal of Molecular Diagnostics
Issue Number	2
Volume Number	13
Language	English
Publisher	Elsevier
Publisher Date	2011-03-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Discipline Molecular Biology Cytological Techniques Papillomaviridae Isolation & Purification Papillomavirus Infections Diagnosis Adolescent Cervix Uteri Cytology Pathology Virology Early Detection Of Cancer Genetics Retrospective Studies Uterine Cervical Neoplasms Comparative Study Evaluation Studies
Content Type	Text
Resource Type	Article
Subject	Molecular Medicine Pathology and Forensic Medicine

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