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, John W. A. Rossen, Daniel Schoener, Diana Thamke, Annika Pettersson, Reiner Babiel, Martin Schutten*

*Corresponding author for this work

    Research output: Contribution to journalArticleAcademicpeer-review

    48 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)1195-1200
    Number of pages6
    JournalJournal of Clinical Microbiology
    Volume48
    Issue number4
    DOIs
    Publication statusPublished - Apr-2010

    Keywords

    • ACID-BASED TECHNIQUES
    • QUANTITATIVE DETECTION
    • MONITOR VERSION-1.5
    • AMPLICOR MONITOR
    • HUMAN PLASMA
    • VIRAL LOAD
    • AMPLIFICATION
    • ASSAY
    • PCR
    • INFECTION

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