title: Negative human papillomavirus testing in normal smears selects a population at low risk for developing high-grade cervical lesions.
abstract: High-risk human papillomaviruses (HR-HPV) are the necessary cause of cervical carcinomas and there is an increasing interest in using HR-HPV DNA detection in adjunction to cytological examination for primary cervical screening. To determine whether women with a normal smear negative for HR-HPV DNA detection with the Hybrid Capture II assay might represent a low-risk population for developing a high-grade squamous intraepithelial lesion (HSIL), 4401 women have been followed in a period of 12-72 months (median=34 months). During this follow-up, four HSIL and one microinvasive carcinoma have been detected in this cohort (three in the cohort of 3526 women >29 years). The global negative predictive value (NPV) of double-negative tests is thus of 99.9% (ninety-five percent confidence interval (95% CI): 99.8-100%), whereas cytology alone gives an NPV of 99.2% (95% CI: 98.9-99.5%). If we obtain a second negative HR-HPV test 1-2 years after the initial test, the NPV is 100%. The NPV is also of 100% in the cohort of women >49 years. We conclude that all these women could be safely screened at longer intervals between 3 and 5 years. This policy will offset the increased costs induced by an additional HR-HPV testing in primary screening.
authors.affiliation: Laboratoire Pol Bouin, Hôpital Maison Blanche, CHU de Reims, 45 rue Cognacq-Jay, Reims 51100, France. cclavel@chu-reims.fr
authors.forename: C
authors.initials: C
authors.lastname: Clavel
authors.forename: J
authors.initials: J
authors.lastname: Cucherousset
authors.forename: M
authors.initials: M
authors.lastname: Lorenzato
authors.forename: S
authors.initials: S
authors.lastname: Caudroy
authors.forename: J M
authors.initials: JM
authors.lastname: Nou
authors.forename: P
authors.initials: P
authors.lastname: Nazeyrollas
authors.forename: M
authors.initials: M
authors.lastname: Polette
authors.forename: J-P
authors.initials: JP
authors.lastname: Bory
authors.forename: R
authors.initials: R
authors.lastname: Gabriel
authors.forename: C
authors.initials: C
authors.lastname: Quereux
authors.forename: P
authors.initials: P
authors.lastname: Birembaut
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000517:prevention & control* / Q000821:virology*; D015344:DNA Probes, HPV; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008403:Mass Screening; D008875:Middle Aged; D027383:Papillomaviridae; D030361:Papillomavirus Infections / Q000175:diagnosis*; D011237:Predictive Value of Tests; D012307:Risk Factors; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control* / Q000821:virology*; D014626:Vaginal Smears
chemical_list: D015344:DNA Probes, HPV