Author(s): Troppan KT, Stelzl E, Violan D, Winkler M, Kessler HH
Abstract Share this page
Abstract BACKGROUND: The VERSANT HIV-1 RNA 1.0 Assay (kPCR) for quantitative detection of HIV-1 RNA has recently been introduced. OBJECTIVES: In this study, the performance of the VERSANT HIV-1 RNA 1.0 Assay (kPCR) was evaluated and compared to the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0. STUDY DESIGN: Accuracy, linearity, interassay and intra-assay variations were determined, and a total of 196 routine clinical samples including a high number of HIV-1 subtype non-B samples were investigated. RESULTS: When accuracy of the new kit was tested, all of the quantifiable results were found to be within -0.5log(10) unit of the expected panel results. Determination of linearity resulted in a quasilinear curve up to the initial concentration of 3.4x10(5)copies/mL. The interassay variation ranged from 12 to 20\%, and the intra-assay variation ranged from 8 to 16\%. When clinical samples were tested by the VERSANT HIV-1 RNA 1.0 Assay (kPCR) and the results were compared with those obtained by the COBAS AmpliPrep/COBAS TaqMan HIV-1 test, version 2.0, the results for 95\% of all samples with positive results by both tests were found to be within +/-1.0log(10) unit. The viral loads for all samples measured by the Siemens and Roche assays showed a high correlation (R(2)=0.94); quantitative results obtained by the Siemens assay were usually found to be lower than those obtained by the Roche assay. CONCLUSIONS: The new VERSANT HIV-1 RNA 1.0 Assay (kPCR) proved to be suitable for use in the routine diagnostic laboratory. The time to results was similar for both of the assays.
This article was published in J Clin Virol
and referenced in Journal of Proteomics & Bioinformatics