Metrological evaluation of methods for control the safety indicators of leukoreduced platelet concentrates

Abstract

Objective. The aim of research was to evaluate experimentally the feasibility of using of control methods of safety indicators of leukoreduced platelet concentrates (CPl). Material and methods. The analysis of 14 leukoreduced platelet concentrates samples was performed. Platelet count was estimated in a 2-grid Goryaev’s camera using a «Mikmed-1» light microscope and conductometry with hydrodynamic focusing on an «XT-4000i» hematology analyzer. To determine the residual number of leukocytes, we used the laser flow cytofluorimetry method by «FACS Canto II» analyzer. The pH was measured by the potentiometric method by a pH-millivoltmeter «pH-150M». The feasibility of applying safety performance monitoring techniques was assessed based on the basis of coefficient of variation (CV) . Results and discussion. The maximum CV value when calculating the platelet count in the Goryaev’s camera was 18,6 %; conductometry method – 2,8 %. CV when determining the residual number of leukocytes by laser flow cytofluorimetry did not exceed 17,5 %. The CV of the method for determining pH by potentiometric method was 0,4 %. Conclusion. To control the platelet count, a unified method of counting in a 2-grid Goryaev’s camera and conductometry method with hydrodynamic focusing on hematology analyzer are recommended. Laser flow cytofluorimetry should be used to determine the residual number of leukocytes. The maximum CV values were taken as the assigned convergence characteristics: for the unified counting method – not more than 18,6 %, for the conductometry method – not more than 2,8 %, for laser flow cytofluorimetry – not more than 17,5 %, for potentiometry – not more than 0,4 %.