Oliver, A. R., Pereira, S. F. and Clark, D. A. (2007) 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. Journal of Clinical Microbiology, 45(11), pp. 3616-3619. (doi: 10.1128/JCM.00221-07) (PMID:17804650) (PMCID:PMC2168503)
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Abstract
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).
| Item Type: | Articles |
|---|---|
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Clark, Dr Duncan |
| Authors: | Oliver, A. R., Pereira, S. F., and Clark, D. A. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Life Sciences |
| Journal Name: | Journal of Clinical Microbiology |
| Publisher: | American Society for Microbiology |
| ISSN: | 0095-1137 |
| ISSN (Online): | 1098-660X |
| Published Online: | 05 September 2007 |
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