Document Detail

Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer.
MedLine Citation:
PMID:  17942871     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: To determine whether testing for DNA of oncogenic human papillomaviruses (HPV) is superior to the Papanicolaou (Pap) test for cervical-cancer screening, we conducted a randomized trial comparing the two methods. METHODS: We compared HPV testing, using an assay approved by the Food and Drug Administration, with conventional Pap testing as a screening method to identify high-grade cervical intraepithelial neoplasia in women ages 30 to 69 years in Montreal and St. John's, Canada. Women with abnormal Pap test results or a positive HPV test (at least 1 pg of high-risk HPV DNA per milliliter) underwent colposcopy and biopsy, as did a random sample of women with negative tests. Sensitivity and specificity estimates were corrected for verification bias. RESULTS: A total of 10,154 women were randomly assigned to testing. Both tests were performed on all women in a randomly assigned sequence at the same session. The sensitivity of HPV testing for cervical intraepithelial neoplasia of grade 2 or 3 was 94.6% (95% confidence interval [CI], 84.2 to 100), whereas the sensitivity of Pap testing was 55.4% (95% CI, 33.6 to 77.2; P=0.01). The specificity was 94.1% (95% CI, 93.4 to 94.8) for HPV testing and 96.8% (95% CI, 96.3 to 97.3; P<0.001) for Pap testing. Performance was unaffected by the sequence of the tests. The sensitivity of both tests used together was 100%, and the specificity was 92.5%. Triage procedures for Pap or HPV testing resulted in fewer referrals for colposcopy than did either test alone but were less sensitive. No adverse events were reported. CONCLUSIONS: As compared with Pap testing, HPV testing has greater sensitivity for the detection of cervical intraepithelial neoplasia. (Current Controlled Trials number, ISRCTN57612064 [].).
Marie-Hélène Mayrand; Eliane Duarte-Franco; Isabel Rodrigues; Stephen D Walter; James Hanley; Alex Ferenczy; Sam Ratnam; François Coutlée; Eduardo L Franco;
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  357     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2007 Oct 
Date Detail:
Created Date:  2007-10-18     Completed Date:  2007-10-25     Revised Date:  2008-02-12    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1579-88     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2007 Massachusetts Medical Society.
Department of Oncology and Epidemiology & Biostatistics, McGill University, Montreal, Canada.
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MeSH Terms
Cervical Intraepithelial Neoplasia / diagnosis*,  pathology
DNA, Viral / analysis*
Double-Blind Method
Middle Aged
Papillomaviridae / genetics,  isolation & purification*
Papillomavirus Infections / diagnosis*
Sensitivity and Specificity
Uterine Cervical Neoplasms / diagnosis*,  pathology
Vaginal Smears*
Reg. No./Substance:
0/DNA, Viral
Comment In:
N Engl J Med. 2007 Oct 18;357(16):1650-3   [PMID:  17942878 ]
N Engl J Med. 2008 Feb 7;358(6):641; author reply 643   [PMID:  18256402 ]
N Engl J Med. 2008 Feb 7;358(6):641-2; author reply 643   [PMID:  18265439 ]
N Engl J Med. 2008 Feb 7;358(6):642; author reply 643   [PMID:  18265441 ]
N Engl J Med. 2008 Feb 7;358(6):642-3; author reply 643-4   [PMID:  18265442 ]
N Engl J Med. 2008 Feb 7;358(6):642; author reply 643   [PMID:  18265440 ]

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