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

M. J. Binnicker, B. S. Pritt, B. J. Duresko, M. J. Espy, Thomas Grys, M. A. Zarka, S. E. Kerr, M. R. Henry

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

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. Copyright

Original languageEnglish (US)
Pages (from-to)3763-3768
Number of pages6
JournalJournal of Clinical Microbiology
Volume52
Issue number10
DOIs
StatePublished - Oct 1 2014

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Human papillomavirus 18
Human papillomavirus 16
Biopsy
Genotype
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Routine Diagnostic Tests
Nucleic Acids
Carcinoma
Sensitivity and Specificity

ASJC Scopus subject areas

  • Microbiology (medical)

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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. / Binnicker, M. J.; Pritt, B. S.; Duresko, B. J.; Espy, M. J.; Grys, Thomas; Zarka, M. A.; Kerr, S. E.; Henry, M. R.

In: Journal of Clinical Microbiology, Vol. 52, No. 10, 01.10.2014, p. 3763-3768.

Research output: Contribution to journalArticle

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abstract = "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. Copyright",
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