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Comparative Study
. 2010 Apr;48(4):1195-200.
doi: 10.1128/JCM.01832-09. Epub 2010 Feb 17.

Performance evaluation of the new Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 for quantification of human immunodeficiency virus type 1 RNA

Suzan Pas  1 , John W A Rossen, Daniel Schoener, Diana Thamke, Annika Pettersson, Reiner Babiel, Martin Schutten
Affiliations
Comparative Study

Performance evaluation of the new Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 for quantification of human immunodeficiency virus type 1 RNA

Suzan Pas et al. J Clin Microbiol. 2010 Apr.

Abstract

Despite FDA approval and CE marking of commercial tests, manufacturer-independent testing of the technical aspects of newly developed tests is important. To evaluate the analytical performance and explore the clinical applicability of the new Roche COBAS AmpliPrep COBAS TaqMan HIV-1 test, version 2.0 (CAP/CTM v2.0), platform comparison was performed with the Roche CAP/CTM test, version 2.0, the COBAS Amplicor HIV-1 Monitor Test, version 1.5 (CAP/CA v1.5), the COBAS AmpliPrep COBAS TaqMan HIV-1 Test (CAP/CTM v1.0), and the Abbott m2000 RealTime HIV-1 assay on panels and diagnostic samples. Specificity was tested for HIV-2 samples. Furthermore, samples from HIV-1-seropositive individuals with CAP/CA v1.5-measured viral loads below 50 HIV-1 RNA copies per ml (cp/ml) and replicates of HIV-1-seronegative plasma were tested in a checkerboard analysis. CAP/CTM v2.0 is HIV-1 specific, with broad genotype inclusivity and no serious underquantification of viral load relative to the other assays used. Low viral loads below the threshold of quantification for CAP/CA v1.5 are observed with CAP/CTM v2.0. A CAP/CTM v2.0-measured viral load of >50 copies/ml in these samples correlated with therapy failure. In conclusion, CAP/CTM v2.0 is an accurate and reliable test for HIV-1 viral load measurement relative to the other assays used with respect to specificity, sensitivity, and genotype inclusivity.

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Figures

FIG. 1.
FIG. 1.
Viral load as measured with CAP/CA v1.5 (triangles), CAP/CTM v1.0 (squares), and CAP/CTM v2.0 of dTTP (circles) and dUTP (diamonds) containing CAP/CA v1.5 amplicons, plotted against the amount of input amplicon as measured with a semiquantitative real-time RT-PCR specific for CAP/CA v1.5 amplicons.
FIG. 2.
FIG. 2.
Viral loads as measured with CAP/CTM v2.0 for samples from HIV-1-infected patients under antiretroviral therapy that were below the limit of quantification (50 cp/ml) as determined by CAP/CA v1.5, plotted against the numbers of months that the patients showed levels below the limit of quantification for CAP/CA v1.5. Samples with viral loads between 20 and 50 cp/ml as determined by CAP/CTM v2.0 are not plotted.
FIG. 3.
FIG. 3.
Probability of treatment failure for patients showing levels below the threshold of quantification for CAP/CA v1.5 who were retested with CAP/CTM v2.0. A 5-cp/ml moving lower limit was set, and the probability of therapy failure for patients with levels below this lower limit was compared to that for patients with levels above this limit and was tested for significance. The figure shows the P values for each limit (P < 0.05 is significant).
FIG. 4.
FIG. 4.
Viral loads of samples from six HIV-1-seronegative but HIV-2-seropositive patients, measured with an in-house-developed HIV-2 real-time quantitative RT-PCR assay, CAP/CTM v2.0, and CAP/CA v1.5, are plotted.
FIG. 5.
FIG. 5.
Viral loads for the WHO 1st reference panel as determined by CAP/CTM v1.0, CAP/CTM v2.0, and the Abbott assay. N.T., not tested.
FIG. 6.
FIG. 6.
Regression plots of Bland-Altman analysis-derived data for CAP/CTM v2.0 compared with results for CAP/CA v1.5 (A), CAP/CTM v1.0 (B), and the Abbot M2000 system (C). Viral loads measured were log10 transformed before analysis. Dashed lines indicate 1-log10 difference from the regression curve.
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