title: Human papillomavirus (HPV) DNA triage of women with atypical squamous cells of undetermined significance with Amplicor HPV and Hybrid Capture 2 assays for detection of high-grade lesions of the uterine cervix.
abstract: Up to 20% of women having a cytology smear showing atypical squamous cells of undetermined significance (ASC-US) and infected with high-risk human papillomavirus (HR HPV) have high-grade cervical intraepithelial neoplasia (CIN 2/3). Results obtained with the Amplicor HPV and Hybrid Capture 2 (HC-2) assays for HR HPV DNA detection in women referred to colposcopy for an ASC-US smear were compared. Cervical samples in PreservCyt were tested for the presence of 13 HR HPV types with HC-2, with Amplicor at three cutoffs for positivity (0.2, 1.0, and 1.5 optical density units), and for 36 genotypes with the Linear Array (LA). Of 396 eligible women, 316 did not have CIN, 47 had CIN 1, 29 had CIN 2/3, and 4 had CIN of unknown grade. HR HPV was detected in 129 (32.6%) and 164 (41.4%) samples with HC-2 and Amplicor HPV (cutoff, 0.2), respectively (P = 0.01). Overall, 112 specimens were positive and 215 were negative with the HC-2 and Amplicor HPV assays (agreement of 82.6%; 95% confidence interval [CI], 78.5 to 86.0). The clinical sensitivity and specificity of Amplicor HPV at cutoffs of 0.2, 1.0 and 1.5 and of HC-2 for detection of CIN 2/3 were 89.7% (95% CI, 72.8 to 97.2) and 62.5% (95% CI, 57.5 to 52.4), 89.7% (95% CI, 72.8 to 97.2) and 64.5% (95% CI, 59.4 to 69.2), 89.7% (95% CI, 72.8 to 97.2) and 64.7% (95% CI, 59.7 to 69.5), and 93.1% (95% CI, 77.0 to 99.2) and 72.2% (95% CI, 67.4 to 76.5), respectively. Both HR HPV detection tests identified women with ASC-US who would benefit the most from colposcopy. Women with persistent HR HPV infection need further investigation despite a first normal colposcopy.
authors.affiliation: Département de Microbiologie et Infectiologie, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.
authors.forename: Simon
authors.initials: S
authors.lastname: Dufresne
authors.forename: Philippe
authors.initials: P
authors.lastname: Sauthier
authors.forename: Marie-Hélène
authors.initials: MH
authors.lastname: Mayrand
authors.forename: Patrick
authors.initials: P
authors.lastname: Petignat
authors.forename: Diane
authors.initials: D
authors.lastname: Provencher
authors.forename: Pierre
authors.initials: P
authors.lastname: Drouin
authors.forename: Philippe
authors.initials: P
authors.lastname: Gauthier
authors.forename: Marie-Josée
authors.initials: MJ
authors.lastname: Dupuis
authors.forename: Bertrand
authors.initials: B
authors.lastname: Michon
authors.forename: Stéphan
authors.initials: S
authors.lastname: Ouellet
authors.forename: Rachid
authors.initials: R
authors.lastname: Hadjeres
authors.forename: Alex
authors.initials: A
authors.lastname: Ferenczy
authors.forename: Eduardo L
authors.initials: EL
authors.lastname: Franco
authors.forename: François
authors.initials: F
authors.lastname: Coutlée
mesh_terms: D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology; D004279:DNA, Viral / Q000302:isolation & purification*; D005260:Female; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology*; D014773:Virology / Q000379:methods*
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic