The application of IFCC reference methods in methodological evaluation of glycated hemoglobin measurement systems / 中华检验医学杂志

ABSTRACT

Objective To perform a methodological evaluation study of 4 HPLC based systems and a capillary electrophoresis based system , with the International Federation of Clinical Chemistry and Laboratory Medicine ( IFCC) glycated hemoglobin reference method as a comparative method .Methods 40 hemolysis samples of variety concentrations were prepared .The samples were measured by IFCC reference method and 5 glycated hemoglobin testing systems , respectively and trueness verification was performed according to the Clinical &Laboratory Standards Institute (CLSI) guideline EP9-A3.Whole blood samples were used to test the systems'precision, linearity and analytical interferences .Results The average CV of IFCC reference method results of 40 hemolysis samples was 1.4％( range from 0.2％to 2.5％).No outlier was found in the results of the 5 testing system.The slopes ranged from 0.9902 to 1.0267, and intercepts from -0.1526 mmol/mol to +0.1512 mmol/mol, squared correlation coefficient from 0.9962-0.9971, biases at two medical decision level were less than 0.3％HbA1c.Within-laboratory precisions were less than 2％ (NGSP unit).Bias between all test results and predicted results were less than 5％.High concentration of glucose showed certain interference to glycated Hemoglobin tests but had little influence in clinical practice.Conclusions The results of the 5 testing system are comparable to the IFCC reference method , the results of precision and linearity evaluation meet the requirements of related guidelines .