EXPERIENCE OF INTRA-LABORATORY QUALITY CONTROL APPLICATION AT DETERMINATION OF CLASS G ANTIBODIES TO MEASLES VIRUS BY IMMUNE-ENZYME ANALYSIS METHOD USING CONTROL DRUG

Measles is a highly contagious infectious disease, fraught with serious complications and even death. The measles elimination program adopted by WHO has produced tangible benefits, but measles is still not defeated. At the stage of measles elimination, measures to increase the reliability of the results and quality of laboratory tests of antibodies to the measles virus become particularly relevant. The purpose of these studies was the validation of the drug “ILC measles-IgG” for the determination of measles antibodies of class G in serum by ELISA and the development of accounting parameters for qualitative and quantitative research options. The study material was commercial reagent kits for determining the concentration of antibodies to the measles virus VeсtoMeasles-IgG (JSC Vector-Best, Novosibirsk, Russia), which determined the concentration of the desired analyte in blood serums of 654 randomly selected conditionally healthy residents of Moscow and the Moscow region in age from 0 to 60 years. When conducting laboratory quality control, “ILC measles-IgG” (lyophilized preparation containing IgG to measles virus) was used to assess the intra- and inter-series convergence of the analysis. It is shown that certified on the basis of the reference laboratory of WHO / Europe of G. N. Gabrichevsky Research Institute for Epidemiology and Microbiology sample “ILC-measles IgG” is suitable for conducting internal laboratory quality control in determining measles IgG in serum using the “VectoMeasles-IgG” kits by the qualitative (OU) and quantitative (IU / ml) method. When assessing the convergence and reproducibility of the results of “ILC IgG-measles”, the CV values should not exceed 8% and 19%, respectively, and the OD values (OU) and IU / ml of “ILC measles-IgG” working solutions (native or diluted 1: 2) should not be in the range of values (points) of test calibration samples.

measles, intra-laboratory quality control, enzyme immunoassay, antibodies, convergence, reproducibility