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- Title
Human papillomavirus oncogenic mRNA testing for cervical cancer screening: baseline and longitudinal results from the CLEAR study.
- Authors
Reid, Jennifer L; Wright, Thomas C Jr; Stoler, Mark H; Cuzick, Jack; Castle, Philip E; Dockter, Janel; Getman, Damon; Giachetti, Cristina
- Abstract
<bold>Objectives: </bold>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. <bold>Methods: </bold>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. <bold>Results: </bold>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%). <bold>Conclusions: </bold>These results support the use of AHPV as a safe and effective adjunctive cervical cancer screening method.
- Publication
American Journal of Clinical Pathology, 2015, Vol 144, Issue 3, p473
- ISSN
0002-9173
- Publication type
journal article
- DOI
10.1309/AJCPHVD7MIP3FYVV