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HIV Infection and Immunosuppressive Disorders, 1(12), p. 123-133, 2020

DOI: 10.22328/2077-9828-2020-12-1-123-133

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Comparative Analysis of Diagnostic Kits for the Quantitative Determination of Hiv-1 Rna Produced in Russia

This paper was not found in any repository; the policy of its publisher is unknown or unclear.
This paper was not found in any repository; the policy of its publisher is unknown or unclear.

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Abstract

Aim: to carry out the comparative analysis of Russian kits for HIV-1 viral load (VL) measuring: AmpliSens HIV-monitor-FRT, AmpliSens HIV-monitor-Duo-FL, RealBest RNA HIV quantitative, HIV-GEN quantitative.Materials and methods: we analyzed the collection of clinical blood plasma samples with VL 590–2,05×106 copies/ml, dilutions of HIV-1 2nd International Standard, as well as panels of subtypes and recombinant forms of HIV-1 group M. The convergence of the results was determined using the Spearman correlation analysis and the Bland-Altman method.Results. A high level of convergence of VL measuring results in clinical samples (n=76) was determined for all compared kits with the value of approximation reliability R of at least 0,85. The maximum difference between the median values of VL results (0,48 log, ≈3-fold) was obtained for HIVMonitor-FRT and RealBest quantitative, which did not exceed the acceptable discordance rate in two kits comparing. All dilutions of the 2nd international HIV-1 standard were successfully determined by all kits with middle error 0,16–0,34 lg copies/ml. All kits successfully revealed the most of HIV-1 subtypes and recombinants studied with middle deviation 0,02–0,56 log copies/ml. HIV-GEN quantitative demonstrated the highest accuracy, but didn’t reveal ADG-recombinant.