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

31 Citations (Scopus)

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 1 2015
Externally publishedYes

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Early Detection of Cancer
Uterine Cervical Neoplasms
Messenger RNA
Colposcopy
Cervical Intraepithelial Neoplasia
Longitudinal Studies
Cell Biology
RNA
DNA
Neoplasms

Keywords

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

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medicine(all)

Cite this

Human papillomavirus oncogenic mRNA testing for cervical cancer screening : Baseline and longitudinal results from the CLEAR study. / Reid, Jennifer L.; Wright, Thomas C.; Stoler, Mark H.; Cuzick, Jack; Castle, Philip E.; Dockter, Janel; Getman, Damon; Giachetti, Cristina.

In: American Journal of Clinical Pathology, Vol. 144, No. 3, 01.09.2015, p. 473-483.

Research output: Contribution to journalArticle

Reid, Jennifer L. ; Wright, Thomas C. ; Stoler, Mark H. ; Cuzick, Jack ; Castle, Philip E. ; Dockter, Janel ; Getman, Damon ; Giachetti, Cristina. / Human papillomavirus oncogenic mRNA testing for cervical cancer screening : Baseline and longitudinal results from the CLEAR study. In: American Journal of Clinical Pathology. 2015 ; Vol. 144, No. 3. pp. 473-483.
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