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Journal of Clinical Microbiology, September 2006, p. 3122-3129, Vol. 44, No. 9
0095-1137/06/$08.00+0     doi:10.1128/JCM.00517-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Evaluation of the SPF10-INNO LiPA Human Papillomavirus (HPV) Genotyping Test and the Roche Linear Array HPV Genotyping Test

Dennis van Hamont,1,2 Maaike A. P. C. van Ham,2 Judith M. J. E. Bakkers,1 Leon F. A. G. Massuger,2 and Willem J. G. Melchers1*

Department of Medical Microbiology, Nijmegen University Centre for Infectious Diseases, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands,1 Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands2

Received 10 March 2006/ Returned for modification 9 May 2006/ Accepted 19 June 2006

The need for accurate genotyping of human papillomavirus (HPV) infections is becoming increasingly important, since (i) the oncogenic potential among the high-risk HPV genotypes varies in the pathogenesis of cervical cancer, (ii) monitoring multivalent HPV vaccines is essential to investigate the efficiency of the vaccines, and (iii) genotyping is crucial in epidemiologic studies evaluating HPV infections worldwide. Various genotyping assays have been developed to meet this demand. Comparison of different studies that use various HPV genotyping tests is possible only after a performance assessment of the different assays. In the present study, the SPF10 LiPA version 1 and the recently launched Roche Linear Array HPV genotyping assays are compared. A total of 573 liquid-based cytology samples were tested for the presence of HPV by a DNA enzyme immunoassay; 210 were found to be positive for HPV DNA and were evaluated using both genotyping assays (163 with normal cytology, 22 with atypical squamous cells of undetermined significance, 20 with mild/moderate dysplasia, and 5 with severe dysplasia). Comparison analysis was limited to the HPV genotype probes common to both assays. Of the 160 samples used for comparison analysis, 129 (80.6%) showed absolute agreement between the assays (concordant), 18 (11.2%) showed correspondence for some but not all genotypes detected on both strips (compatible), and the remaining 13 (8.2%) samples did not show any similarity between the tests (discordant). The overall intertest comparison agreement for all individually detectable genotypes was considered very good ({kappa} value, 0.79). The genotyping assays were therefore highly comparable and reproducible.

* Corresponding author. Mailing address: Department of Medical Microbiology (internal postal code 699), Nijmegen Centre for Molecular Life Sciences, Nijmegen University Centre for Infectious Diseases, Radboud University Nijmegen Medical Centre, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands. Phone: 31 (0)24 3614356. Fax: 31 (0)24 3540216. E-mail: w.melchers{at}mmb.umcn.nl.

Journal of Clinical Microbiology, September 2006, p. 3122-3129, Vol. 44, No. 9
0095-1137/06/$08.00+0     doi:10.1128/JCM.00517-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



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