Abstract
Objective To explore the correlation and clinical application of turbidimetric inhibition immunoassay (TINIA) and ion-exchange high-performance liquid chromatography (HPLC) for detecting glycosylated hemoglobin (HbAlC).Methods According to the criteria on NCCLS,experiments of precision,linearity,method comparison,and bias were conducted.The results were analyzed by regression equation and t test.Results The concentration of HbAlc at a range of 3.9％-15.2％ had good repeatability and linearity for TINIA or HPLC.Bias analysis showed TINIA and HPLC were negative bias as HbAlc was at higher level,and were positive bias at lower level.The data in the two groups had no statistical significance in method comparison (P＞0.05).The correlation analysis with the result of TINIA determination as Y axis and that of HPLC as X axis revealed y =0.7857x +1.264 and r =0.89,being positively related.Conclusions Through methodological evaluation,these two methods for determining HbAlC precision and linear range meets clinical requirement,with comparable results.HPLC,which has better repeatability,is more suitable for clinical monitoring in the treatment of diabetes mellitus. Key words: Glycated hemoglobin; Immunosuppressive Turbidimetry; Ion exchange high performance liquid chromatography
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