Human papillomavirus oncogenic mRNA testing for cervical cancer screening: Baseline and longitudinal results from the CLEAR study

Jennifer L. Reid, Thomas C. Wright, Mark H. Stoler, Jack Cuzick, Philip E. Castle, Janel Dockter, Damon Getman, Cristina Giachetti

Research output: Contribution to journalArticle

33 Scopus citations

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 languageEnglish (US)
Pages (from-to)473-483
Number of pages11
JournalAmerican journal of clinical pathology
Volume144
Issue number3
DOIs
StatePublished - Sep 2015
Externally publishedYes

Keywords

  • Adjunct screening
  • Aptima HPV
  • Cervical cancer
  • Cervical intraepithelial neoplasia
  • E6/E7 mRNA

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

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  • Cite this

    Reid, J. L., Wright, T. C., Stoler, M. H., Cuzick, J., Castle, P. E., Dockter, J., Getman, D., & Giachetti, C. (2015). Human papillomavirus oncogenic mRNA testing for cervical cancer screening: Baseline and longitudinal results from the CLEAR study. American journal of clinical pathology, 144(3), 473-483. https://doi.org/10.1309/AJCPHVD7MIP3FYVV