Evaluation of the method for quantitative determination of soybean line MON 89788 by PCR-RF method

The method for quantitative determination of soybean line MON 89788 by polymerase chain reaction was evaluated in accordance with European standards and norms. Intra-laboratory studies were conducted in accordance with the acceptance criteria and performance requirements described in the documents of the European GMO Laboratory Network. The efficiency of the test system was assessed by such characteristics as amplification efficiency and linearity, reproducibility (intra-laboratory precision), analytical sensitivity of the test system, accuracy and convergence. As a result of the studies, a high level of amplification efficiency was established, the slope angle was between – 3.43 and – 3.52, and the calculated efficiency values were 95.1 and 92.2 %. A clear linear dependence of the Сt values of the studied samples on the logarithm of the initial concentration of soybean line MON 89788 was also established, and the correlation coefficient R² was more than 0.99. To assess reproducibility, a comparison was made between the calculated coefficient of variation (% CV) of Ct values for the MON89788 transformation event and the acceptable coefficient of variation value for the method (% CVv), and satisfactory reproducibility of the results of MON89788 quantification on the MA6000 instrument was established. Analyzing the results of all studies studied during verification, it can be concluded that the use of the PCR-RT method using the Biocore® GMO-quantity test system kit Soy MON 89788 is suitable and effective for the quantitative determination of GM soybean MON 89788. The obtained verification parameters comply with EU standards, which makes it possible to apply the specified method in laboratory practice.