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.
Highlights
Materials and methods: we analyzed the collection of clinical blood plasma samples with viral load (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
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
Summary
Для всех сравниваемых наборов реагентов был получен высокий уровень сходимости результатов измерения вирусной нагрузки (ВН) ВИЧ-1 клинических образцов (n=76) с величиной достоверности аппроксимации R не менее 0,85. Максимальная разница между медианными значениями результатов ВН (0,48 lg, ≈3 раза) была получена для ВИЧ-Монитор-FRT и РеалБест количественный, что не превышало допустимого уровня при сравнении двух систем. For citation: Lapovok I.A., Lopatukhin A.E., Kirichenko A.A., Murzakova A.V., Kireev D.E. Comparative analysis of diagnostic kits for the quantitative determination of HIV-1 RNA produced in Russia // HIV infection and immunosuppression.
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