Abstract

MUNERA-JARAMILLO, María Isabel; RAMIREZ-PUERTA, Blanca Susana; CARRILLO-AVILA, Sandra Milena  and  ROJAS-RIOS, Randy. Comparison of COBAS® AmpliPrep/COBAS® TaqMan HIV-1 test, v 2.0 and VERSANT HIV-1 RNA 1.0 (kPCR) assays for HIV-1 plasma viral load. Infect. [online]. 2012, vol.16, n.1, pp.8-14. ISSN 0123-9392.

Objective: The purpose of this study was to evaluate the performance of the kPCR VERSANT (™) 440 HIV-1RNA 3.0 Assay® (Siemens) method for the quantification of viral load in HIV-1 patients, compared to the COBAS AmpliPrep/COBASTaqMan HIV-1 test®, v. 2.0 (Roche Diagnostics) (CAP/CTM). Methods: Samples were taken in 2 tubes with EDTA, in 60 patients referred by the attending physician for viral load tests as part of their routine control of HIV/AIDS, and were processed for quantification of HIV-1 RNA by both techniques. A regression analysis, the Pearson correlation coefficient and agreement of Lin were done. The agreement between the two techniques was evaluated with the Bland Altman analysis. Results: The mean viral load by CAP/CTM was 3.2 ± 1.4 long₁₀ copies/ml and by kPCR it was 3.0±1.3 ₁₀ copies/ml. Most samples (86.7%) showed differences between the two methods lower than 0.5 long₁₀ copies/ml, and 13.3% presented greater differences. The Pearson correlation coefficient between the two methods was 0.97 (95% CI 0.95-0.99) and the weighted kappa index between the two methods, in different ranges of concentration, was 0.91 (95% CI 0.87-0.96). The average difference between measurements by both techniques was 0.22 long₁₀ copies/ml, (IC 95% -0.45-0.89). Conclusion: Both techniques were comparable, although lower values of viral load were observed with kPCR.

Keywords : HIV-1; viral load; Polymerase Chain Reaction (PCR).

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