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Journal of Clinical Microbiology, November 2007, p. 3616-3619, Vol. 45, No. 11
0095-1137/07/$08.00+0     doi:10.1128/JCM.00221-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Comparative Evaluation of the Automated Roche TaqMan Real-Time Quantitative Human Immunodeficiency Virus Type 1 RNA PCR Assay and the Roche AMPLICOR Version 1.5 Conventional PCR Assay

Diagnostic Virology (Division of Infection), Barts and the London NHS Trust, Pathology & Pharmacy Building, 80 Newark Street, London E1 2ES, United Kingdom

Received 29 January 2007/ Returned for modification 10 June 2007/ Accepted 25 August 2007

The need to evaluate antiviral treatment response and the emergence of resistance have made the human immunodeficiency virus (HIV) viral load assay a major feature of the diagnostic monitoring of HIV-infected individuals. The objective of this study was to evaluate the utility of the recently In Vitro Diagnostic Medical Devices Directive-approved Roche COBAS AmpliPrep/TaqMan96 real-time PCR assay by comparison with the existing Roche COBAS AmpliPrep/AMPLICOR MONITOR conventional PCR assay. EDTA-treated plasma samples from 191 HIV-1-infected individuals were tested for HIV-1 RNA by the AMPLICOR assay and the TaqMan assay. This was a prospective study using 191 pairs of samples from the same bleed per patient. The correlation coefficient of the assays was 98.08%. The mean difference between the assays was 0.05 log₁₀ copy/ml plasma, with a standard deviation (SD) of 0.27 log₁₀ copy/ml plasma. Thirteen samples gave results with variances greater than 0.5 log₁₀ copy/ml plasma, which is our clinical cutoff. Two samples were more than 3 SD different (0.81 log₁₀ copy/ml plasma). The TaqMan assay appeared to be slightly more sensitive at the lower end of the dynamic range. The assays correlated significantly (P > 0.95) with each other, and the regression analysis was also highly significant (R² > 0.95).

Published ahead of print on 5 September 2007.

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