Evaluation of the new versant HIV1 RNA 1.0 Assay (kPCR) for quantification of human immunodeficiency virus type 1 RNA
Abstract number: P1921
Amendola A., Zaccaro P., Sabatini R., Bibbo A., Bloisi M., Patella E., Natale A., Rossi G., Capobianchi M.R.
Objective: To compare performance of the new Versant HIV-1 RNA 1.0 (kPCR) assay (Siemens Healthcare Diagnostics) for quantification of HIV-1 RNA in clinical samples from HIV-1-infected individuals with Versant HIV-1 RNA v3.0 (Siemens Healthcare Diagnostics) and COBASAmpliprep/COBASTaqMan HIV-1 CAP-TCM (Roche Diagnostics) procedures. Versant HIV-1 RNA 1.0 (kPCR) and COBASAmpliprep/COBASTaqMan HIV-1 assays are both based on RT real-time PCR technology; Versant HIV-1 RNA v3.0 is based on bDNA technology and was considered as reference method.
Methods: The study was conducted on 256 retrospectively collected plasma samples from HIV-1 infected individuals attending the out-patient care facility of the "Lazzaro Spallanzani" Hospital in Rome. Quantitative results were compared with correlation, linear regression, Bland&Altman and k-statistic analyses of log10 transformed HIV-1 RNA copy numbers.
Results: Agreement between Versant HIV-1 RNA 1.0 (kPCR) and other assays was elevated (>0.940) and high correlation coefficients were measured: r = 0.9662, p < 0.0001 between Versant HIV-1 RNA 1.0 (kPCR) and Versant HIV-1 RNA v3.0 (bDNA); r= 0.9597, p < 0.0001 between Versant HIV-1 RNA 1.0 (kPCR) and COBAS Ampliprep/COBAS TaqMan HIV-1. Analysis of mean differences of measurement between assays, conducted according to Bland&Altman method, showed no clinically significant differences in quantification of viral load (lower than 0.2 log10 cp/ml) along all the overlapping range.
Conclusion: Versant HIV-1 RNA 1.0 (kPCR) assay for quantification of HIV-1 RNA in plasma samples from HIV-infected individuals is based on RT real-time PCR technology. This new commercially available diagnostic system produces viral load results that can be considered equivalent to results given by the reference diagnostic system and a similar RT-real-time PCR-based procedure.
|Session name:||19th European Congress of Clinical Microbiology and Infectious Diseases|
|Location:||Helsinki, Finland, 16 - 19 May 2009|
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