The reproducibility of qualitative measurement of RNA HIV-1, RNA hcv and RNA hbv using amplisens reagents' kits

The evaluation of reproducibility of three reagents' kits AmpliSens for quantitative measurement of RNA HIV-1, RNA HCV and RNA HBV using retrospective analysis of protocols of output control of reagents' kits produced by the central research institute of epidemiology of Rospotrebnadzor in 2014-2016. For every reagents' kits more than 100 produced series are analyzed. The total number of tested samples for every reagents' kits was at least 590. For every sample a difference between passport and experimental value of decimal algorithm of concentration of RNA/DNA of virus (dLg) was calculated. The obtained values of dLg were used to determine median and standard deviation (SD). The obtained values of SD were accepted as a reproducibility. The calculations were implemented using Microsoft Excel 2010. The average reproducibility according samples with various concentration of RNA HIV-1 made up to 0,218 Lg, RNA HCV - 0,191 Lg and I'M HBV- 0,174 Lg. The least reproducibility of measurement was observed for concentrations corresponding to lower limit of linear range of qualitative measurement and it made up to for RNA HIV1 0,275 Lg. RNA HCV - 0,206 Lg and RNA HBV- 0,211 Lg. The obtained reproducibility of the given reagents' kits AmpliSens is comparable with reproducibility of reagents' kits of foreign manufacturers. There is no necessity to enhance achieved reproducibility because, taking into account actual recommendations on treatment of patients with HIV and viral hepatitis B and C, according to them a therapy is considered effective when viral load decreases up to 10-100 times and even up to non-detectable levels.