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Journal of Clinical Microbiology, June 2005, p. 2662-2667, Vol. 43, No. 6
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.6.2662-2667.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Comparison of Two Commercial Assays for Detection of Human Papillomavirus (HPV) in Cervical Scrape Specimens: Validation of the Roche AMPLICOR HPV Test as a Means To Screen for HPV Genotypes Associated with a Higher Risk of Cervical Disorders

Maaike A. P. C. van Ham,1 Judith M. J. E. Bakkers,2 Gonneke K. Harbers,2 Wim G. V. Quint,3 Leon F. A. G. Massuger,1 and Willem J. G. Melchers2*

Department of Gynaecology and Obstetrics,1 Department of Medical Microbiology, Nijmegen University Center for Infectious Diseases, Radboud University Medical Center, Nijmegen,2 Delft Diagnostic Laboratory, Delft, The Netherlands3

Received 12 October 2004/ Returned for modification 13 December 2004/ Accepted 7 January 2005

Certain high-risk (HR) human papillomavirus (HPV) types are a necessary cause for the development of cervical disorders. Women with persistent HR HPV infections have an increased risk of developing high-grade cervical lesions, compared with those who have no or low-risk HPV infections. Therefore, implementation of HPV detection into cervical screening programs might identify women at risk of cervical cancer. Several HPV detection methods with different sensitivities and specificities are available. Recently, a new PCR-based technique, the Roche AMPLICOR HPV Test, was developed. This test recognizes a group of 13 HR HPV types simultaneously. This study was undertaken to validate and compare HPV detection in 573 cervical scrape specimens by the AMPLICOR HPV Test and the INNO-LiPA HPV detection/genotyping assay (SPF10-LiPA system version 1). Human ß-globin was not detected in nine specimens, which were therefore excluded from the comparison. Eleven scrape specimens containing HPV type 53 or 66 were also excluded from the comparison because these (probably) HR HPV types cannot be detected by the AMPLICOR HPV Test. The results of HPV detection by the Roche AMPLICOR HPV Test were confirmed by INNO-LiPA HPV detection/genotyping assay in 539/553 cases, showing an absolute agreement of 97.5% with a Cohen's kappa of 0.9327, indicating almost complete similarity of the two tests. Like the INNO-LiPA HPV detection/genotyping assay, the AMPLICOR HPV Test was sensitive, specific, feasible, and easy to handle. The value of the Roche AMPLICOR HPV Test with a broad-spectrum HR HPV detection has to be determined in prospective clinical studies.

* Corresponding author. Mailing address: Department of Medical Microbiology, Radboud University Medical Center Nijmegen, NCMLS/NUCI, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands. Phone: 0031 24 3614356. Fax: 0031 24 3540216. E-mail: w.melchers{at}ncmls.ru.nl.

Journal of Clinical Microbiology, June 2005, p. 2662-2667, Vol. 43, No. 6
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.6.2662-2667.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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