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 theHigh-risk human papillomavirus (HR HPV) genotypes are associated with high-grade cervical intraepithelial neoplasia (CIN 2/3) and cancer of the uterine cervix (2, 3). Primary screening of cervical cancer is essentially based on Pap cytology testing. In North America, for each new case of cervical cancer screened by cytology, there are between 50 and 100 cases of abnormal smears consistent with low-grade squamous intraepithelial lesions (LSIL) or high-grade squamous intraepithelial lesions (HSIL) (9). Additionally, there are at least twice as many cases of equivocal or borderline atypias, referred to as "atypical squamous cells of undetermined significance" (ASC-US). Three options have been proposed by the American Society for Colposcopy and Cervical Pathology to perform triage on women with ASC-US, namely, repeat cytology, immediate referral to colposcopy, and reflex HR HPV testing (28).The most widely used HR HPV detection assay for the triage of women with ASC-US is the Hybrid Capture 2 assay (HC-2; Qiagen, Inc., Mississauga, Ontario, Canada) (15). The HC-2 and Amplicor HPV (Roche Diagnostics, Laval, Quebec, Canada) tests detect the same 13 HR genotypes and are approved by Health Canada for clinical use. Several studies have evaluated the Amplicor HPV test, but only one analyzed fresh samples collected from women with ASC-US (4,11,14,15,25,26,27). The evaluation of the performance of the Amplicor HPV test in a diagnostic setting is mandatory to assess its utility in the management of women with ASC-US. We evaluated the clinical performance of two generic HPV assays, Amplicor HPV and HC-2, on fresh clinical specimens obtained prospectively from women referred to colposcopy because of an ASC-US cytology result. HPV genotypic analysis was performed on all samples to assess the cross-reactivity of the HPV generic assays.
MATERIALS AND METHODSStudy design and population. Participants were recruited consecutively if (i) they were referred to colposcopy because of at least one ASC-US cytology, (ii) were Ն24 years old, and (iii) had not received treatment for CIN in the last 2 years. During the study period, HPV DNA testing was not widely available to primary care physicians in the study area and women were referred to colposcopy