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A modified Latent Class Model assessment of human papillomavirus-based screening tests for cervical lesions in women with atypical glandular cells: a Gynecologic Oncology Group study

Randy L. Carter, Le Kang, Kathleen M. Darcy, James Kauderer, Shu-Yuan Liao, William H. Rodgers, Joan L. Walker, Heather A. Lankes, S. Terence Dunn and Eric J. Stanbridge
Cancer Causes & Control
Vol. 23, No. 12 (December 2012), pp. 2013-2021
Published by: Springer
Stable URL: http://www.jstor.org/stable/23274613
Page Count: 9
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Abstract

Purpose: In the absence of gold standard diagnoses, we estimate age-specific false-positive and false-negative prediction rates of HPV-, cytology-, and histology-based tests for significant cervical lesions (SCL) in US women with AGC-NOS Pap smear diagnoses. Methods: Modified Latent Class Model (LCM) analyses, with prevalence of SCL modeled as a function of age, were applied to GOG-0171 study data (n = 122). The accuracies of several HPV-based tests, including Hybrid Capture II high-risk HPV (HC2 H-HPV); carbonic anhydrase IX (CA-IX); and invasive histological diagnosis, were compared. 1-PPV and 1-NPV were written as functions of sensitivity, specificity, and prevalence to obtain age-specific false-positive and false-negative rates. Results: The histology-based test was nearly perfect (sensitivity = 1.00, CI = 0.98—1.00; specificity = 0.99, CI = 0.96—1.00). Otherwise, HC2 H-HPV performed best (sensitivity = 1.00, CI = 1.00—1.00; specificity = 0.87, CI = 0.79—0.94). The false-positive detection rates (1-PPV) for HC2 H-HPV were high (>17 %) at each age, while those of the histological diagnoses were low (<5 % at ages ≤60 and <17 % overall ages). False-negative prediction rates (1-NPV) for HC2 H-HPV were <0.11 % at each age and were uniformly lower than those of other tests, including the histology-based test (<0.25 %). CA-IX together with HC2 H-HPV did not improve performance. Conclusions: Women with negative HC2 H-HPV can safely forego invasive treatment (i.e., cone or LEEP biopsy, hysterectomy) in favor of observational follow-up. Additional biomarkers must be found for use in combination with HC2 H-HPV to reduce false-positive rates. This novel application of a modified LCM exemplifies methods for potential use in future cancer screening studies when gold standard diagnoses are not available.

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