离子交换层析法测量糖化血红蛋白的不确定度评定及应用

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Abstract Objective To evaluate the uncertainty of glycosylated hemoglobin (HbA1c) measuredby ion-exchange chromatography, and todiscussthe application value of uncertainty in clinical diagnosis and treatment. Methods The source of uncertainty were combed from pre-analysis, analytical phase, physiological variation, some diseases influence factors, and so on. Then the standard uncertainty and expanded uncertainty were calculated and the clinical applications of uncertainty in clinical diagnosis and treatmentwere illustrated. Results The main source of the uncertainty on HbA1c measured by ion exchange chromatography were imprecision, systematic error, the uncertainty of calibration product and errors caused by calibration product redissolved during measurement. The pre-analysis factors could be controlled by pre-analysis quality control. Physiological variation and other disease affecting factors wereonly related to some individuals without universality, which could not taken into consideration. The relative standard uncertainties of the internal quality control concentrationsin 5.11% and 10.04% were 6.33% and 4.54% respectively, the standard uncertainties were 0.32% and 0.46% respectively and the expanded uncertainty were 0.64% and 0.92% respectively. Two HbA1c measurements near by 5.11%, 10.04% for respectively. Taking the uncertainty into consideration, the possibility of suffering from diabetes could be excluded when HbA1c concentration of patient ＜5.86%, in addition diabetes could be diagnosed when HbA1c>7.14%. While patientscould not be determined whether suffering from diabetes when HbA1c value is located between 5.86% and 7.14%, which needed further examination to confirm. Conclusion The main source of the uncertainty on HbA1c measurement by ion exchange chromatography are measurement imprecision, systematic error, the uncertainty of calibrator productand the errors caused by calibrator product redissolving. The uncertainty is significant to diagnose clinical diseases and evaluate curative effect.

Key words： Glycosylated hemoglobin Ion exchange chromatography Uncertainty Evaluation and application value

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	DIAO Qizhi1 HUANG Lijun1 MO Zhan1 ZENG Qiang1 WANG Kaihua2▲

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DIAO Qizhi1 HUANG Lijun1 MO Zhan1 ZENG Qiang1 WANG Kaihua2▲. Evaluation and application of uncertainty in HbA1c measurement by ion exchange chromatography[J]. 中国医药导报, 2018, 15(10): 131-134.

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http://www.yiyaodaobao.com.cn/EN/ OR http://www.yiyaodaobao.com.cn/EN/Y2018/V15/I10/131

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