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Journal of Clinical Microbiology, December 2006, p. 4371-4375, Vol. 44, No. 12
0095-1137/06/$08.00+0     doi:10.1128/JCM.00505-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Multicenter Performance Evaluation of a New TaqMan PCR Assay for Monitoring Human Immunodeficiency Virus RNA Load{triangledown}

L. Perrin,1 J. M. Pawlotsky,2 M. Bouvier-Alias,2 C. Sarrazin,3 S. Zeuzem,3 and G. Colucci4*

Clinical Virology, University of Genève, Genève, Switzerland,1 Department of Bacteriology and Virology, Hôpital Henri Mondor, Créteil, France,2 Department of Internal Medicine, University Hospital, Homburg-Saar, Homburg, Germany,3 Roche Molecular Diagnostics, Rotkreuz, Switzerland4

Received 8 March 2006/ Returned for modification 30 August 2006/ Accepted 12 September 2006

A TaqMan real-time PCR assay, the COBAS TaqMan human immunodeficiency virus (HIV) (HPS-CTMHIV) PCR assay, recently developed for the quantification of HIV type 1 RNA in plasma, was evaluated in comparison with the licensed COBAS AMPLICOR HIV-1 MONITOR (CAHIM) assay. In this study, we have analyzed the tests' sensitivities, precisions, and linearities using multiple replicates of a standard panel of HIV RNA covering a 7-logarithm range of concentrations, as well as serial threefold dilutions of high-titer clinical samples. The subtype inclusivity was also investigated, using a panel of subtypes A to H, while a collection of 160 clinical samples was analyzed to assess the tests' specificities and the systems' similarities. The results of these experiments showed that the HPS-CTMHIV assay has a sensitivity of 53 copies/ml (95% hit rate), 100% specificity, and good intra- and interassay precision. The results of the HPS-CTMHIV assay were linear in the 50- to 107-copies/ml range, with a correlation coefficient (R) for expected versus observed results of 0.98. Compared to the CAHIM assay, the HPS-CTMHIV assay showed a high correlation (R = 0.99) across the dynamic range of RNA concentrations that, for the CAHIM assay, requires two different sample preparations. Equivalent performances were also observed for the two systems in the detection and quantification of HIV subtypes A to H. These data indicate that the HPS-CTMHIV assay may be one of the tests of choice for monitoring viral load throughout the course of HIV infection and during highly active antiretroviral therapy.

* Corresponding author. Mailing address: Roche Molecular Diagnostics, Roche Instrument Center AG, Lettenstrasse, 6343 Rotkreuz, Switzerland. Phone: 41 41 7992815. Fax: 41 41 7992845. E-mail: giuseppe.colucci.gc1{at}roche.com.

{triangledown} Published ahead of print on 27 September 2006.

Journal of Clinical Microbiology, December 2006, p. 4371-4375, Vol. 44, No. 12
0095-1137/06/$08.00+0     doi:10.1128/JCM.00505-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



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