Journal
AMERICAN JOURNAL OF CLINICAL PATHOLOGY
Volume 144, Issue 3, Pages 473-483Publisher
OXFORD UNIV PRESS INC
DOI: 10.1309/AJCPHVD7MIP3FYVV
Keywords
Aptima HPV; Adjunct screening; Cervical cancer; E6/E7 mRNA; Cervical intraepithelial neoplasia
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Funding
- Cancer Research UK [16891] Funding Source: researchfish
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Objectives: This study determined the longitudinal clinical performance of a high-risk human papillomavirus (HR-HPV) E6/E7 RNA assay (Aptima HPV [AHPV]; Hologic, San Diego, CA) compared with an HR-HPV DNA assay (Hybrid Capture 2 [HC2]; Qiagen, Gaithersburg, MD) as an adjunctive method for cervical cancer screening. Methods: Women 30 years or older with a negative result for intraepithelial lesions or malignancy cytology (n = 10,860) positive by AHPV and/or HC2 assays and randomly selected women negative by both assays were referred to colposcopy at baseline. Women without baseline cervical intraepithelial neoplasia (CIN) grade 2 or higher (CIN2+) continued into the 3-year follow-up. Results: The specificity of AHPV for CIN2 or lower was significantly greater at 96.3% compared with HC2 specificity of 94.8% (P < .001). Estimated sensitivities and risks for detection of CIN2+ were similar between the two assays. After 3 years of follow-up, women negative by either human papillomavirus test had a very low risk of CIN2+ (<0.3%) compared with CIN2+ risk in women with positive AHPV results (6.3%) or positive HC2 results (5.1%). Conclusions: These results support the use of AHPV as a safe and effective adjunctive cervical cancer screening method.
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