Evaluation of Any or Type-Specific Persistence of High-Risk Human Papillomavirus for Detecting Cervical Precancer Morgan A. Marks a , Philip E. Castle b , Mark Schiffman c and Patti E. Gravitt a , d a Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA b American Society for Clinical Pathology Institute, Washington, DC, USA c Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA d Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA ABSTRACT High-risk human papillomavirus (HR-HPV) testing is increasingly important. We therefore examined the impact on accuracy of repeated versus one-time testing, type-specific versus pooled detection, and assay analytic sensitivity. By using a nested case-control design from the ASCUS-LSIL Triage Study, we selected women with incident cervical intraepithelial neoplasia grade 2 or grade 3 (CIN2/3; n = 325) and a random sample of women with <CIN2 as controls ( n = 401). HPV DNA status was assessed using hybrid capture 2 (HC2), a pooled test for 13 HR-HPV types, and the linear array (LA) and the line blot assay (LBA), two PCR-based HPV genotyping assays, at enrollment and the 6-month follow-up visit. The relative sensitivity and specificity for different permutations of multiple measurements were compared to a single measurement using marginal regression models. We found that repeat detection of any HR-HPV (by HC2, LA, or LBA) and of type-specific persistence (by LA or LBA) were significantly more specific but less sensitive than use of a single time point measurement of any HR-HPV. Sensitivity decreased and specificity increased further when testing intervals were increased from 12 to 24 months. Including detection of borderline carcinogenic/noncarcinogenic HPV types with HR-HPV types decreased specificity for repeat measures of HPV with no impact on sensitivity. Similar patterns were observed when we used a CIN3 end point. We conclude that assay performance for detecting incident CIN2/3 was affected by which types were included, the analytic sensitivity of the assay, and the testing interval. These trade-offs need to be considered when assessing the potential overall clinical utility of repeated testing for HR-HPV DNA to identify women at risk for CIN2/3.
Evaluation of Any or Type-Specific Persistence of High-Risk Human Papillomavirus for Detecting Cervical Precancer
Abstract
Evaluation of Any or Type-Specific Persistence of High-Risk Human Papillomavirus for Detecting Cervical Precancer Morgan A. Marks a , Philip E. Castle b , Mark Schiffman c and Patti E. Gravitt a , d a Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA b American Society for Clinical Pathology Institute, Washington, DC, USA c Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA d Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA ABSTRACT High-risk human papillomavirus (HR-HPV) testing is increasingly important. We therefore examined the impact on accuracy of repeated versus one-time testing, type-specific versus pooled detection, and assay analytic sensitivity. By using a nested case-control design from the ASCUS-LSIL Triage Study, we selected women with incident cervical intraepithelial neoplasia grade 2 or grade 3 (CIN2/3; n = 325) and a random sample of women with <CIN2 as controls ( n = 401). HPV DNA status was assessed using hybrid capture 2 (HC2), a pooled test for 13 HR-HPV types, and the linear array (LA) and the line blot assay (LBA), two PCR-based HPV genotyping assays, at enrollment and the 6-month follow-up visit. The relative sensitivity and specificity for different permutations of multiple measurements were compared to a single measurement using marginal regression models. We found that repeat detection of any HR-HPV (by HC2, LA, or LBA) and of type-specific persistence (by LA or LBA) were significantly more specific but less sensitive than use of a single time point measurement of any HR-HPV. Sensitivity decreased and specificity increased further when testing intervals were increased from 12 to 24 months. Including detection of borderline carcinogenic/noncarcinogenic HPV types with HR-HPV types decreased specificity for repeat measures of HPV with no impact on sensitivity. Similar patterns were observed when we used a CIN3 end point. We conclude that assay performance for detecting incident CIN2/3 was affected by which types were included, the analytic sensitivity of the assay, and the testing interval. These trade-offs need to be considered when assessing the potential overall clinical utility of repeated testing for HR-HPV DNA to identify women at risk for CIN2/3.Preview Only. This article cannot be rented because we do not currently have permission from the publisher.
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Evaluation of Any or Type-Specific Persistence of High-Risk Human Papillomavirus for Detecting Cervical Precancer
Marks, Morgan A.; Castle, Philip E.; Schiffman, Mark; Gravitt, Patti E.
Follow Journal of Clinical Microbiology
, Volume 50 (2): 300
American Society For Microbiology – Feb 1, 2012
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