Evaluation of the new VERSANT HIV-1 RNA 1.0 Assay (kPCR) for quantitative detection of human immunodeficiency virus type 1 RNA

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 −0.5 log 10 unit of the expected panel results. Determination of linearity resulted in a quasilinear curve up to the initial concentration of 3.4 × 10 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 ±1.0 log 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.