TY - JOUR
T1 - Comparative evaluation of three commercial systems for detection of High-Risk Human papillomavirus in cervical and vaginal ThinPrep PreservCyt samples and correlation with Biopsy Results
AU - Binnicker, M. J.
AU - Pritt, B. S.
AU - Duresko, B. J.
AU - Espy, M. J.
AU - Grys, T. E.
AU - Zarka, M. A.
AU - Kerr, S. E.
AU - Henry, M. R.
N1 - Publisher Copyright:
© 2014, American Society for Microbiology. All Rights Reserved.
PY - 2014/10/1
Y1 - 2014/10/1
N2 - Genital human papillomavirus (HPV) is the etiologic agent of more than 99% of all cervical cancers worldwide, with 14 genotypes being considered oncogenic or "high risk" because of their association with severe dysplasia and cervical carcinoma. Among these 14 high-risk types, HPV-16 and -18 account for approximately 70% of cervical cancers. The aim of this study was to evaluate three FDA-approved HPV nucleic acid-based tests for the ability to predict high-grade cervical intraepithelial neoplasias (CIN2 or worse) in corresponding tissue biopsy specimens. Residual specimens (total n=793, cervical n=743, vaginal n= 50) collected in ThinPrep PreservCyt medium with a cytologic result of>atypical squamous cells of undetermined significance were tested by the Hybrid Capture 2 (HC2) assay (Qiagen, Gaithersburg, MD), the cobas HPV test (Roche Diagnostics, Indianapolis, IN), and the APTIMA HPV assay (Hologic, San Diego, CA). Genotyping for HPV-16 and HPV-18 was simultaneously performed by the cobas HPV test. Results were compared to cervical or vaginal biopsy findings, when they were available (n=350). Among the 350 patients with corresponding biopsy results, 81 (23.1%) showed>CIN2 by histopathology. The>CIN2 detection sensitivity was 91.4% by the cobas and APTIMA assays and 97.5% by HC2 assay. The specificities of the cobas, APTIMA, and HC2 assays were 31.2, 42.0, and 27.1%, respectively. When considering only positive HPV-16 and/or HPV-18 genotype results, the cobas test showed a sensitivity and a specificity of 51.9 and 86.6%, respectively. While the HC2, cobas, and APTIMA assays showed similar sensitivities for the detection of>CIN2 lesions, the specificities of the three tests varied, with the greatest specificity (86.6%) observed when the HPV-16 and/or HPV-18 genotypes were detected.
AB - Genital human papillomavirus (HPV) is the etiologic agent of more than 99% of all cervical cancers worldwide, with 14 genotypes being considered oncogenic or "high risk" because of their association with severe dysplasia and cervical carcinoma. Among these 14 high-risk types, HPV-16 and -18 account for approximately 70% of cervical cancers. The aim of this study was to evaluate three FDA-approved HPV nucleic acid-based tests for the ability to predict high-grade cervical intraepithelial neoplasias (CIN2 or worse) in corresponding tissue biopsy specimens. Residual specimens (total n=793, cervical n=743, vaginal n= 50) collected in ThinPrep PreservCyt medium with a cytologic result of>atypical squamous cells of undetermined significance were tested by the Hybrid Capture 2 (HC2) assay (Qiagen, Gaithersburg, MD), the cobas HPV test (Roche Diagnostics, Indianapolis, IN), and the APTIMA HPV assay (Hologic, San Diego, CA). Genotyping for HPV-16 and HPV-18 was simultaneously performed by the cobas HPV test. Results were compared to cervical or vaginal biopsy findings, when they were available (n=350). Among the 350 patients with corresponding biopsy results, 81 (23.1%) showed>CIN2 by histopathology. The>CIN2 detection sensitivity was 91.4% by the cobas and APTIMA assays and 97.5% by HC2 assay. The specificities of the cobas, APTIMA, and HC2 assays were 31.2, 42.0, and 27.1%, respectively. When considering only positive HPV-16 and/or HPV-18 genotype results, the cobas test showed a sensitivity and a specificity of 51.9 and 86.6%, respectively. While the HC2, cobas, and APTIMA assays showed similar sensitivities for the detection of>CIN2 lesions, the specificities of the three tests varied, with the greatest specificity (86.6%) observed when the HPV-16 and/or HPV-18 genotypes were detected.
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U2 - 10.1128/JCM.01928-14
DO - 10.1128/JCM.01928-14
M3 - Article
C2 - 25122861
AN - SCOPUS:84907164461
SN - 0095-1137
VL - 52
SP - 3763
EP - 3768
JO - Journal of clinical microbiology
JF - Journal of clinical microbiology
IS - 10
ER -