A Preliminary Study of the Trueness and Harmonization of Insulin Chemiluminescence Immunoassay Systems
Objective This study aims to conduct a preliminary study for the evaluation of the trueness and harmonization of insulin chemiluminescence test systems.Methods WHO 66/304 series concentration dilution solutions,and 20 single human sera covering the concentration range of 0-350μIU/mL were tested simultaneously on five fully automated chemiluminescence immunoassay systems.The system trueness was evaluated by calculating the relative deviation(bias)with reference to YY/T1250-2014,and the commutability of the standard and their dilutions were analyzed with reference to CLSI EP30-A.Results Except for the lowest concentration(-2μIU/mL),the relative bias of the test results of WHO 66/304 series of concentration dilutions compared with the theoretical target values was calculated;Most of the results of systems A,B,and C were within the clinically permissible deviation of±18.5％,and the maximal deviation of systems D and E reached 40.2％and 39.8％,respectively.The calibrator dose-response curves of systems D and E were significantly deviated from WHO 66/304;The mean value of the difference between the highest and lowest deviation among systems was 36％.The relative bias of the test results of human serum samples compared with the total mean of the five systems was calculated,and the relative bias of most of the results of the five systems did not significantly deviate from the clinically permissible bias of±18.5％;The mean value of the difference between the highest and lowest bias among the systems was 48％.Deming regressions of human serum between system combinations showed slopes far from 1 or intercepts far from 0;WHO 66/304 series of concentration dilutions were less commutable between the five systems,except for the A-C system combination.Conclusion The international standard,WHO 66/304,for the trueness evaluation of insulin chemiluminescence immunoassay systems has some limitations,and the standardization(harmonization)of insulin items still needs improvements when compared with clinical requirements.
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