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Early Detection and Diagnosis
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Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid-based cytology in primary cervical cancer screening: The FASE study†
Article first published online: 8 DEC 2010
DOI: 10.1002/ijc.25726
Copyright © 2010 UICC
Additional Information
How to Cite
Monsonego, J., Hudgens, M. G., Zerat, L., Zerat, J.-C., Syrjänen, K., Halfon, P., Ruiz, F. and Smith, J. S. (2011), Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid-based cytology in primary cervical cancer screening: The FASE study. Int. J. Cancer, 129: 691–701. doi: 10.1002/ijc.25726
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Conflict of interest: J. Monsonego has received funding to conduct studies related to the FASE study from Gen-Probe Inc. and related to HPV vaccines from Merck and GlaxoSmithKline, and has participated to Steering Committees at Merck and to the Advisory Board of Sanofi Pasteur MSD, Gen-Probe, Qiagen, and Roche Diagnostics. J. Smith has received research grants or contracts, honoraria and consulting fees during the last three years from Qiagen or Genprobe. F. Ruiz is an employee of ClinSearch. K. Syrjänen, M. Hudgens, P. Halfon, L. Zerat and J.C. Zerat have no conflict of interest to report.
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Publication History
- Issue published online: 26 MAY 2011
- Article first published online: 8 DEC 2010
- Accepted manuscript online: 12 OCT 2010 08:09AM EST
- Manuscript Accepted: 16 SEP 2010
- Manuscript Received: 23 JUN 2010
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Keywords:
- cervical cancer screening;
- HPV RNA test;
- HPV DNA test;
- liquid-based cytology;
- high-grade CIN
Abstract
The APTIMA® HPV Assay (AHPV) allows detection of 14 high-risk human papillomavirus (HPV) RNA types in cervical specimens. Until present, the assay has been compared to HPV DNA tests only in triage settings. Herein, we compare AHPV with a DNA assay (Hybrid Capture® 2; HC2) and liquid-based cytology (LBC; using PreservCyt® ThinPrep liquid Pap) in a screening setting (French APTIMA screening evaluation [FASE] study). Women (N = 5,006) aged 20–65 were screened by gynecologists in 17 private practices in Paris, France. One cervical specimen was collected and tested with LBC, AHPV and HC2 assays. Women were referred to colposcopy if they were ASC-US+ in LBC or HPV positive in either HPV assay. To control for verification bias, a random group (14%) with normal LBC and dually HPV negative tests underwent colposcopy. Data from 4,429 women were analyzed. Sensitivity, specificity and predictive values were calculated for the three tests. AHPV and HC2 were highly sensitive for CIN2+ (92.0% and 96.7%) and CIN3+ (95.7% and 95.3%) detection and much more sensitive than LBC (69.1% for CIN2+ and 73.3% for CIN3+). Specificity of AHPV was higher than that of HC2, but similar to that of LBC (p < 0.001). Combining LBC with either HPV test slightly increased sensitivity but compromised specificity. AHPV assay is both specific and sensitive for the detection of high-grade precancerous lesions and may be considered as an option for routine cervical cancer screening for women over 20 years of age.