Abstract
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.
Original language | English (US) |
---|---|
Pages (from-to) | 473-483 |
Number of pages | 11 |
Journal | American journal of clinical pathology |
Volume | 144 |
Issue number | 3 |
DOIs | |
State | Published - Sep 2015 |
Externally published | Yes |
Keywords
- Adjunct screening
- Aptima HPV
- Cervical cancer
- Cervical intraepithelial neoplasia
- E6/E7 mRNA
ASJC Scopus subject areas
- Pathology and Forensic Medicine