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J. Clin. Microbiol. doi:10.1128/JCM.00706-06
Copyright (c) 2006, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Agreement Between the AMPLICOR^® HPV Test and the Hybrid Capture^® 2 Assay in the Detection of High-Risk Human Papillomavirus and Biopsy-confirmed High-Grade Cervical Disease

Centro per lo Studio e la Prevenzione Oncologica, Analytical Cytology and BioMolecular Unit, Via Cosimo il Vecchio 2, 50127 Florence, Italy

^* To whom correspondence should be addressed. Email: f.carozzi{at}cspo.it.

	Abstract

The AMPLICOR^® HPV Test (AMP) and the Hybrid Capture 2^® (HC2) assay detect 13 high-risk (HR) human papillomavirus (HPV) types. Evaluation of comparative performance in clinical samples is needed to allow informed implementation of AMP into clinical practice. AMP was used a) to assess prevalence of HR-HPV in 1032 samples of known cytology, HC2-status and/or confirmed histology, b) to determine agreement between these tests c) to evaluate clinical sensitivity and specificity for detecting HR HPV and d) for detecting 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 HC2 negative specimens, 488 (95.9%) were AMP negative. Of 427 HR-HPV HC2 positive specimens, 347 (81.2%) were AMP positive. When comparing the ability to detect high grade squamous intraepithelial lesions (HSIL) the two tests were positive in all HSIL samples. Both tests performed similarly on CIN2+ samples (clinical sensitivity was 96.7% and 97.8%, respectively for AMP and HC2). Clinical specificity of AMP and HC2 was comparable (54.9% vs 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 in samples with high-grade cytology, and similar sensitivity in detecting CIN2+ lesions.

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