APTIMA HPV assay performance in women with atypical squamous cells of undetermined significance cytology results.

Abstract

The objective of the study was to determine the sensitivity and specificity of the APTIMA human papillomavirus (AHPV) assay for high-grade cervical intraepithelial neoplasia (CIN) in women 21 years old and older with atypical squamous cells of undetermined significance (ASC-US) cytology. Women 21 years old and older with ASC-US cytology had colposcopy/biopsy and molecular human papillomavirus testing. Performance of the AHPV and Hybrid Capture 2 assays was compared with a clinical diagnosis of CIN grade 2, CIN grade 3, or adenocarcinoma in situ (CIN2 or greater). Of 939 evaluable subjects, CIN2 or greater and CIN3 or greater prevalence was 9.7% and 4.4%, respectively. AHPV sensitivity and specificity was 86.8% and 62.9% for CIN2 or greater detection and 90.2% and 60.2% for CIN3 or greater, respectively. AHPV had a similar sensitivity to Hybrid Capture 2 but a significantly higher specificity (62.9% vs 55.8%, P < .001) for CIN2 or greater detection. Among women with ASC-US cytology, detection of high-risk human papillomavirus E6/E7 oncogenic messenger ribonucleic acid is an effective triage method for colposcopy referral.