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The application of IFCC reference methods in methodological evaluation of glycated hemoglobin measurement systems / 中华检验医学杂志
Chinese Journal of Laboratory Medicine ; (12): 821-826, 2018.
Article in Chinese | WPRIM | ID: wpr-712221
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 .

Full text: Available Index: WPRIM (Western Pacific) Type of study: Practice guideline / Prognostic study Language: Chinese Journal: Chinese Journal of Laboratory Medicine Year: 2018 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Practice guideline / Prognostic study Language: Chinese Journal: Chinese Journal of Laboratory Medicine Year: 2018 Type: Article