Document Detail


Rate of detection of high-risk HPV with two assays in women ≥ 30 years of age.
MedLine Citation:
PMID:  21724457     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: High-risk (HR) human papillomavirus (HPV) prevalence rates, as determined by the Cervista(®) HPV HR test, in women aged ≥30 years in a routine screening population have not been studied.
OBJECTIVES: The primary objective of this study was to estimate HR HPV prevalence in women negative for intraepithelial lesion or malignancy (NILM) cytology using the CERVISTA HPV HR test. The study also compared HR HPV prevalence rates in women aged ≥30 years and NILM cytology using the CERVISTA HPV HR and Hybrid Capture(®) 2 (hc2) tests.
STUDY DESIGN: A multi-center study was conducted to analyze HR HPV prevalence rates using the CERVISTA HPV HR test from residual ThinPrep(®) specimens. HR HPV positive rates were determined for hc2; percent agreement between the CERVISTA HPV HR and the hc2 tests were reported.
RESULTS: HR HPV prevalence rates among women with NILM cytology were not statistically different between the CERVISTA HPV HR and hc2 tests (6.92% [98/1417] versus 5.93% [84/1417], respectively; P>0.05). The overall percent agreement between the tests was 95.3% (1351/1417; 95% confidence interval [CI]: 94.1-96.3; κ=0.61, 95% CI: 0.53-0.70). There were no statistically significant differences between tests across age groups or investigational sites. For both tests, there was a statistically significant decrease in HR HPV positive results as age increases (CERVISTA HPV HR, P=0.0009; hc2, P<0.0001).
DISCUSSION: There is no statistically significant difference between HR HPV prevalence rates obtained with the CERVISTA HPV HR and hc2 tests in women aged ≥30 years with NILM cytology.
Authors:
Neil B Quigley; Nicholas T Potter; Mamatha Chivukula; Mirna Z Knight; James R Welch; Marilyn C Olson
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2011-07-02
Journal Detail:
Title:  Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology     Volume:  52     ISSN:  1873-5967     ISO Abbreviation:  J. Clin. Virol.     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-08-09     Completed Date:  2012-01-06     Revised Date:  2012-05-11    
Medline Journal Info:
Nlm Unique ID:  9815671     Medline TA:  J Clin Virol     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  23-7     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Elsevier B.V. All rights reserved.
Affiliation:
Clinical Research Services, Molecular Pathology Laboratory Network, Inc., Maryville, TN 37804, USA. nquigley@mplnet.com
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Alphapapillomavirus / isolation & purification*
Cervical Intraepithelial Neoplasia / diagnosis,  pathology,  virology
Cytological Techniques
Diagnostic Tests, Routine / methods*
Female
Humans
Mass Screening / methods
Middle Aged
Papillomavirus Infections / diagnosis,  epidemiology,  virology*
Uterine Cervical Neoplasms / diagnosis,  epidemiology,  pathology
Comments/Corrections
Erratum In:
J Clin Virol. 2012 May;54(1):100

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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