[Preparation for state registration of the reagent kit for the detection and differentiation of the DNA of burkholderia «pseudomallei» group.].

The reagent kit designed to detect and simultaneously differentiate the DNA of three species of Burkholderia pseudomallei - causative agents of melioidosis (B. pseudomallei), glanders (B. mallei) and B. thailandensis by the set of genes of β-lactamases with B and D molecular classes using a multiplex polymerase chain reaction with electrophoretic detection was developed for clinical laboratory diagnosis. The functional properties of the reagent kit were evaluated, tests were carried out, the stages of examination and registration in the Federal Service for Surveillance on Consumer Rights' Protection and Human Well-being were completed. During clinical testing the effectiveness of the reagent kits in the study of various samples of clinical material and isolated cultures of microorganisms was confirmed. It has been established that the indicator of diagnostic sensitivity of the reagent kit for the detection and differentiation of the glanders, melioidosis and B. thailandensis causative agents was less than 99 %, diagnostic specificity - not less than 99 % with a confidence probability of 90 % in the analysis of each of the indicators.