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.
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.
Authors: Kimberly A Sollis; Pieter W Smit; Susan Fiscus; Nathan Ford; Marco Vitoria; Shaffiq Essajee; David Barnett; Ben Cheng; Suzanne M Crowe; Thomas Denny; Alan Landay; Wendy Stevens; Vincent Habiyambere; Jos Perrins; Rosanna W Peeling Journal: PLoS One Date: 2014-02-18 Impact factor: 3.240