Affiliation:
1. Centro per lo Studio e la Prevenzione Oncologica, Analytical Cytology and BioMolecular Unit, Via Cosimo il Vecchio 2, 50127 Florence, Italy
Abstract
ABSTRACT
The AMPLICOR HPV test (AMP) and the Hybrid Capture 2 assay (HC2) detect 13 high-risk human papillomavirus (HR-HPV) types. Evaluation of comparative performance with clinical samples is needed to allow informed implementation of AMP into clinical practice. AMP was used (i) to assess the prevalence of HR-HPV in 1,032 samples of known cytology, HC2 status, and/or confirmed histology; (ii) to determine agreement between AMP and HC2; (iii) to evaluate the clinical sensitivity and specificity for detecting HR-HPV; and (iv) to detect the presence of biopsy-confirmed high-grade cervical intraepithelial neoplasia. The prevalence of HR-HPV was 39.3% and 45.6% by AMP and HC2, respectively. Overall agreement was 89.2% (kappa value, 0.78). Of 509 HR-HPV-negative specimens by HC2, 488 (95.9%) were AMP negative. Of 427 HR-HPV-positive specimens by HC2, 347 (81.2%) were AMP positive. In comparing the ability to detect high-grade squamous intraepithelial lesions (HSIL), the two tests were positive for all HSIL samples. Both tests performed similarly on CIN2+ samples (clinical sensitivities were 96.7% and 97.8%, respectively, for AMP and HC2). The clinical specificities of AMP and HC2 were comparable (54.9% versus 51.6%;
P
= 0.18). Genotyping of 20 HC2-negative/AMP-positive cases using alternative technologies revealed target HR genotypes in 63.1% of cases and low-risk types in 15.7% of cases, while 21% of cases were negative. In conclusion, AMP provides a viable alternative to HC2, with good agreement for samples with high-grade cytology and similar sensitivity in detecting CIN2+ lesions.
Publisher
American Society for Microbiology
Reference30 articles.
1. Agorastos, T., K. Dinas, B. Lloveras, S. de Sanjose, J. R. Kornegay, H. Bonti, F. X. Bosch, T. Constantinidis, and J. Bontis. 2005. Human papillomavirus testing for primary screening in women at low risk of developing cervical cancer. The Greek experience. Gynecol. Oncol.96:714-720.
2. Bais, A. G., M. Rebolj, P. J. Snijders, F. A. de Schipper, D. A. van der Meulen, R. H. Verheijen, F. Voorhorst, M. van Ballegooijen, C. J. Meijer, and T. J. Helmerhorst. 2005. Triage using HPV-testing in persistent borderline and mildly dyskaryotic smears: proposal for new guidelines. Int. J. Cancer116:122-129.
3. Bollmann, R., A. Bankfalvi, H. Griefingholt, A. Trosic, N. Speich, C. Schmitt, and M. Bollmann. 2005. Validity of combined cytology and human papillomavirus (HPV) genotyping with adjuvant DNA-cytometry in routine cervical screening: results from 31031 women from the Bonn-region in West Germany. Oncol. Rep.13:915-922.
4. Carozzi, F. M., M. Confortini, S. Cecchini, S. Bisanzi, M. P. Cariaggi, G. Pontenani, M. R. Raspollini, C. Sani, M. Zappa, and S. Ciatto. 2005. Triage with human papillomavirus testing of women with cytologic abnormalities prompting referral for colposcopy assessment. Cancer105:2-7.
5. Results of Human Papillomavirus DNA Testing with the Hybrid Capture 2 Assay Are Reproducible
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