Comparison of the Results of Biochemical Studies and Analytical Properties of Reagent Kits Manufactured by «biolabo/ Biosystems» (France/Spain) and CJSC «vector-Best» (Russia)

The article presents the results and evaluation of comparative studies on 10 major biochemical analytes - alanylaminotransferase (ALT), asparaginaminotransferase (AST), amylase, total bilirubin (TB), total protein (TP), glucose, creatinine, creatine kinase (KK), urea, alkaline phosphatase (ALP). Reagent kits for biochemical analyses produced by JSC «Vector-Best» (Russia), intended for use on automatic open-type biochemical analyzers, were used. The comparison of the research results was carried out both in the field of normal reference and pathological values using control materials from «Bio-Rad» (USA), JSC «Vector Best» (Russia) and pathological blood sera in parallel with modern reagents produced by foreign companies «BioLabo» (France) and «BioSystems» (Spain). Biochemical studies were carried out on automatic open biochemical analyzer systems «Ellipse AMS» and «SAT 450 AMS» (Italy). Comparative analysis showed a high degree of correlation between the reference and test reagent kits according to the Bio-Rad control material analytes: for ALT - r=0.998, AST - r=0.997, amylase - r=0.989, TB - r=0.992, TP - r=0.963, glucose - r=0.996, creatinine - r=0.994, CK - r=0.995, urea - r=0.992, ALP - r=0.996. Similar comparative studies were conducted on the control serum of JSC «Vector Best», where good comparative results were also obtained. So the correlation coefficient was for ALT - r=0.993, AST - r=0.993, amylase - r=0.986, TB - r=0.987, TP - r=0.923, glucose - r=0.997, creatinine - r=0.982, CK - r=0.996, urea - r=0.99, ALP - r=0.966. The performed studies of control materials demonstrated compliance with the requirements of reproducibility and accuracy of measurements. A high level of correlations was also obtained in the study on two sets of reagents based on the results of studies of sera of patients with normal and pathological values of these analytes. The results of the correlation coefficients were for ALT - r=0.994, AST - r=0.993, amylase - r=0.979, TP - r=0.993, ТВ - r=0.966, glucose - r=0.949, creatinine - r=0.991, CK - r=0.995, urea - r=0.993, ALP - r=0.966.