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Journal of Clinical Microbiology, February 2007, p. 364-369, Vol. 45, No. 2
0095-1137/07/$08.00+0     doi:10.1128/JCM.00706-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Agreement between the AMPLICOR Human Papillomavirus Test and the Hybrid Capture 2 Assay in Detection of High-Risk Human Papillomavirus and Diagnosis of Biopsy-Confirmed High-Grade Cervical Disease{triangledown}

Francesca Carozzi,* Simonetta Bisanzi, Cristina Sani, Marco Zappa, Silvia Cecchini, Stefano Ciatto, and Massimo Confortini

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

Received 4 April 2006/ Returned for modification 12 June 2006/ Accepted 9 November 2006

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.

* Corresponding author. Mailing address: Centro per lo Studio e la Prevenzione Oncologica, Unità Operativa Citologia Analitica e Molecolare, Via Cosimo il Vecchio 2, 50127 Firenze, Italy. Phone: 055-32697852. Fax: 055-32697879. E-mail: f.carozzi{at}cspo.it.

{triangledown} Published ahead of print on 22 November 2006.

Journal of Clinical Microbiology, February 2007, p. 364-369, Vol. 45, No. 2
0095-1137/07/$08.00+0     doi:10.1128/JCM.00706-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



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