METROLOGICAL EVALUATION OF QUALITY CONTROL METHODS OF ERYTHROCYTE-CONTAINING BLOOD COMPONENTS

Abstract

Objective – to evaluate experimentally the suitability of quality control methods used to control the quality of erythrocyte-containing blood components. Material and methods. In order to assess the metrological characteristics of the techniques, 46 samples of erythrocyte-containing blood components were analyzed: 10 samples of erythrocyte mass, 26 samples of erythrocyte suspension, 6 samples of erythrocyte suspension of leukoreduced and 4 samples of leukoreduced platelet concentrate. For determining the hemoglobin content as a negative control («placebo» sample), «Sodium chloride, 0.9 % infusion solution» was used. The hemoglobin content (total and free) was determined by three methods: hemiglobincyanide method, non-cyanide SLS method using a hematology analyzer «Sysmex XT-4000i-1», and photometric method using a portable analyzer «HemoCue Hb 201+». Two methods were used to determine hematocrit: a unified method of centrifugation in hematocrit capillaries, a conductometric method using a hematology analyzer «Sysmex XT-4000i-1». Counting the number of residual leukocytes was performed by three methods: a unified method of counting in 2 Goryaev chambers, flow cytometry using a «Sysmex XT-4000i-1» hematology analyzer, and flow cytometry using a «FACS CantoTMII analyzer». Results and discussion. The maximum values of coefficients of variation of the analysis methods of total hemoglobin and the hemolysis degree by the hemiglobincyanide method, hematocrit – by the unified method, were 3.03, 20.71 and 1.83 %, respectively. When using the analyzer «Sismex XT-4000i-1», the coefficients of variation of the methods for determining the hemoglobin content ranged from 0.29 to 0.54 %, hematocrit from 0.58 to 1.87 %. In the course of comparing the three methods for determining the amount of residual leukocytes in the leukoreduced blood components, it was concluded that it is advisable to use the flow cytometry method on the «FACS CantoTMII analyzer». The attributed characteristic of the technique was 19.8 %. Conclusion. For the control of total hemoglobin and the degree of hemolysis, the hemiglobincyanide method and the uncyanide SLS method using the «Sysmex XT-4000i» hematology analyzer are recommended. Hematocrit determination should be carried out using a unified method and using a «Sysmex XT-4000i» hematology analyzer. The amount of residual leukocytes in leukoreduced components is recommended to be determined by flow cytometry using a «FACS CantoTMII» analyzer.

Keywords

• validation
• erythrocyte-containing blood components
• quality control
• methods of analysis
• metrological characteristics