title: 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.
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 log(10) copy/ml plasma, with a standard deviation (SD) of 0.27 log(10) copy/ml plasma. Thirteen samples gave results with variances greater than 0.5 log(10) copy/ml plasma, which is our clinical cutoff. Two samples were more than 3 SD different (0.81 log(10) 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 (R(2) > 0.95).
authors.affiliation: Diagnostic Virology (Division of Infection), Barts and the London NHS Trust, Pathology & Pharmacy Building, London, UK. tony.oliver@bartsandthelondon.nhs.uk
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Oliver
authors.forename: Spyridon F
authors.initials: SF
authors.lastname: Pereira
authors.forename: Duncan A
authors.initials: DA
authors.lastname: Clark
mesh_terms: D005838:Genotype; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods*; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood*; D019562:Viral Load