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Correlation between hybrid capture II high-risk human papillomavirus DNA test chemiluminescence intensity from cervical samples with follow-up histologic results
A cytologic/histologic review of 367 cases
Article first published online: 24 JUN 2010
Copyright © 2010 American Cancer Society
Volume 118, Issue 4, pages 209–217, 25 August 2010
How to Cite
Knoepp, S. M., Kuebler, D. L. and Wilbur, D. C. (2010), Correlation between hybrid capture II high-risk human papillomavirus DNA test chemiluminescence intensity from cervical samples with follow-up histologic results. Cancer Cytopathology, 118: 209–217. doi: 10.1002/cncy.20093
- Issue published online: 16 AUG 2010
- Article first published online: 24 JUN 2010
- Manuscript Accepted: 21 MAY 2010
- Manuscript Revised: 13 APR 2010
- Manuscript Received: 12 FEB 2010
- cervical cytology;
- human papillomavirus (HPV) testing;
- Hybrid Capture II
The Hybrid Capture II high-risk human papillomavirus (hrHPV) DNA test is a US Food and Drug Administration-approved nucleic acid hybridization assay using chemiluminescence for the semiquantitative detection of hrHPV in cervical samples. Patient samples and controls are used to calculate results as negative for hrHPV if <1.0, positive for hrHPV if >2.5, and “equivocal” if between 1.0 and 2.5.
The authors reported on the cervical histologic results of 209 patients demonstrating “equivocal” results for hrHPV from SurePath (204 patients) or ThinPrep (5 patients) vials, and compared patients in this cohort with atypical squamous cells of undetermined significance (ASC-US) cytology on the index cervical Papanicolaou (Pap) test (Group 1; n = 148 patients) with a patient cohort demonstrating unequivocal positive hrHPV test results (Group 2; n = 148 patients). The chemiluminescence intensity of hrHPV tests from patients in Group 2 were correlated with the presence and severity of dysplasia on subsequent histologic results, and patients were thereby stratified for their subsequent risk of cervical intraepithelial neoplasia (CIN) types II/III.
Approximately 97% of hrHPV tests demonstrating “equivocal” results were found to be positive at the time of retesting, and 15% of biopsied cases demonstrated CIN II or III. Results of follow-up histology after an ASC-US diagnosis, expressed as a percentage of the biopsied cohort, were: CIN II/III: 16.5% in Group 1 and 22.4% in Group 2; CIN I: 27% in Group 1 and 23.5% in Group 2; and negative: 56.5% in Group 1 and 54.1% in Group 2. Chemiluminescence intensity did not appear to be correlated with the severity of dysplasia.
The percentage of high-grade CIN in the “equivocal” hrHPV cohort is highly significant and therefore the management of these patients should be similar to the unequivocally positive population. After an unequivocal positive hrHPV test, the hrHPV chemiluminescence intensity does not appear to further predict the rate of high-grade CIN. Cancer (Cancer Cytopathol) 2010. © 2010 American Cancer Society.