Applied capillary electrophoresis system affects screening for monoclonal gammopathy in serum: verification study of two eight-capillary systems.

Capillary electrophoresis is a method with a long history of developments which enables monitoring of several pathological processes and has an irreplaceable role in screening for presence of M-protein. The aim of this study was to assess analytical performance of Sebia and Helena systems, as well as their screening efficiency for M-protein by identifying characteristic electrophoretic pattern abnormalities. The controls were analyzed in triplicate over a five-day period. Comparability testing was performed on 46 (Capillarys3Octa) and 49 (V8Nexus) serum samples with routinely used Capillarys2. Electropherograms (EPGs) were reviewed by two specialists independently to select samples for further processing by immunofixation. All precision test results met the eligibility criteria by Ricos et al. The correlation coefficients higher than 0.8 indicated excellent comparability although the results were slightly more comparable among the same manufacturer systems. There were no variations in observed abnormalities in EPGs when Capillarys systems were compared, but a disparity was detected in 11/49 EPGs on comparing Capillarys2 and V8Nexus. The cause of the detected difference could be in a different graphical presentation of the findings and in a lesser resolution of the applied buffer. The impression is that the V8Nexus system combined with the utilized buffer provides greater resolution in the alpha-1 and alpha-2 globulin fractions, but that it declines in the gamma globulin fraction. The precision and estimated accuracy criteria were met by both systems. Comparison results implied that capillary systems are not equally effective in M-protein screening, highlighting the necessity to include system screening efficiency in analytical evaluation.