ResearchGeneral gynecologyComparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the ATHENA HPV study
Section snippets
Study protocol
As previously described, the ATHENA HPV study enrolled more than 47,000 women aged 21 years and older who presented for cervical cancer screening; all eligible participants had both Papanicolaou testing (by liquid-based cytology, ThinPrep; Hologic, Bedford, MA) and HPV testing (by Amplicor HPV test, Linear Array high-risk HPV genotyping test, and the cobas HPV Test, all from Roche Molecular Systems).6 The protocol was approved by the institutional review boards at all study sites, and all women
Results
A total of 34,254 women aged 30 years or older were eligible for this analysis; the mean age was 44.7 years, and the demographics are shown in Table 1. Among the eligible women, 2872 (8.4%) tested positive with the cobas HPV Test, and 1966 (5.7%) had abnormal cytology; 280 women were diagnosed with CIN2 or more severe and 189 with CIN3 or more severe. The most sensitive screening strategy was screening with HPV alone (pooled 14 high-risk types) with referral of all HPV-positive women to
Comment
The ideal cervical cancer screening strategy would provide maximum sensitivity to minimize missing disease as well as maximum specificity to minimize false positive results and overreferral. Unfortunately, cervical cancer screening strategies that maximize both sensitivity and specificity have proven elusive because strategies that maximize sensitivity have typically produced relatively poor specificity. The development of invasive cervical cancer is typically a slow process that takes decades
Acknowledgments
We thank Teresa Wright, MD, for her valuable contributions to the design and execution of the ATHENA HPV Study and for assistance in the analysis of data. The ATHENA study testing sites and participants include the following: United States, Comprehensive Clinical Trials, West Palm Beach, FL; Green Clinic, Ruston, LA; Philadelphia Clinical Research, Philadelphia, PA; Visions Clinical Research, Boynton Beach, FL; Women's Health Specialist, Costa Mesa, CA; Mount Vernon Clinical Research, Atlanta,
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2021, Clinical Microbiology and InfectionCitation Excerpt :Since G5+/6+ PCR-EIA is not used and HC2 is less commonly used in current screening practice, we considered the Cobas 4800 as an alternative comparator HPV assay. Cobas 4800 has been consistently validated against the standard comparator HPV tests in multiple studies [12,19,20] and has been evaluated in a regulatory trial against cytology that demonstrated a strong reduction in the longitudinal risk of CIN3+ among Cobas 4800 negative women [21,22]. A representative set of consecutively or randomly collected samples should be evaluated (minimally 60 CIN2+ cases, 800 ≤CIN1 cases) derived from a population-based screening cohort of women aged 30–60 years [13].
This study was supported by Roche Molecular Systems.
J.T.C. and P.E.C. are compensated for their services as members of a Data Monitoring Board for HPV vaccines for Merck. J.T.C. has received honoraria from Roche for assistance in the development of an educational slide set and for speaking on the cobas HPV Test. He has also received honoraria for service on the scientific advisory board for Gen-Probe and advisory boards for Graceway and Bradley Pharmaceuticals. P.E.C. has received HPV tests and testing for research at a reduced or no cost from Roche and Qiagen. T.C.W. is compensated for his services as a reference pathologist, clinical adviser, and speaker for Roche, Gen-Probe, BD Diagnostics, and Ikonisys. He has received honoraria for serving on a scientific advisory board for HPV vaccines for Merck. J.C. has served on advisory boards for Roche, Gen-Probe, Abbott, and Qiagen. C.M.B. and A.S. are employees of Roche Molecular Systems.
Cite this article as: Cox JT, Castle PE, Behrens CM, et al. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the ATHENA HPV study. Am J Obstet Gynecol 2013;208:184.e1-11.