糖化血红蛋白检测结果的置信区间_West China Medical Journal

Authors：

罗开宏 , 何訸 , 张玫 , 徐克和 , 唐书强 ,  黄亨建

四川大学华西医院实验医学科（成都 610041）;

Corresponding author：

黄亨建, Email: huanghenjian@sina.com

Keywords：

糖化血红蛋白; 实验室测量固有分析变异; 个体内生物学变异; 置信区间

DOI：

10.7507/1002-0179.201607121

Video：

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目的应用生物学变异和分析变异探讨糖化血红蛋白（glycosylated hemoglobin，HbA1c）测定结果对糖尿病诊断治疗的影响。方法以三级质量规范为标准，应用 HbA1c 生物学变异和参考变化值，分析实验室测量固有分析变异（analytical variance，CV_A）、个体内生物学变异（within-individual variation，CV_I）以及偏倚对 HbA1c 测定结果的影响。结果 HbA1c 的测定结果随 CV_A 的增加而导致的额外偏倚不呈线性增加。不同的生物学变异质量规范要求对 HbA1c 测定结果的影响有差异。不同的 CV_A 对非糖尿病个体和糖尿病患者的 HbA1c 测定结果离散范围影响不同。HbA1c 检测要求分析方法的 CV_A<3%。结论糖尿病诊断和治疗并不能单独依赖 HbA1c 测定结果的实际数值为判断标准。应结合 CV_A 及 CV_I 对于 HbA1c 测定值偏倚的影响给出测定值，并附上置信区间。

Citation： 罗开宏, 何訸, 张玫, 徐克和, 唐书强, 黄亨建. 糖化血红蛋白检测结果的置信区间. West China Medical Journal, 2017, 32(7): 1057-1059. doi: 10.7507/1002-0179.201607121 Copy

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1. American Diabetes Association. Standards of medical care in diabetes--2010. Diabetes Care, 2010, 33(Suppl 1): S11-S61.
2. Standards of medical care in diabetes--2015: summary of revisions. Diabetes Care, 2015, 38(Suppl): S4.
3. Ricós C, Iglesias N, García-Lario JV, et al. Within-subject biological variation in disease: collated data and clinical consequences. Ann Clin Biochem, 2007, 44(Pt 4): 343-352.
4. Braga F, Dolci A, Mosca A, et al. Biological variability of glycated hemoglobin. Clin Chim Acta, 2010, 411(21-22): 1606-1610.
5. Harris EK, Yasaka T. On the calculation of a " reference change” for comparing two consecutive measurements. Clin Chem, 1983, 29(1): 25-30.
6. Fraser CG, Hyltoft Petersen P, Libeer JC, et al. Proposals for setting generally applicable quality goals solely based on biology. Ann Clin Biochem, 1997, 34(Pt 1): 8-12.
7. Ricós C, Cava F, García-Lario JV, et al. The reference change value: a proposal to interpret laboratory reports in serial testing based on biological variation. Scand J Clin Lab Invest, 2004, 64(3): 175-184.
8. Lenters-Westra E, Weykamp C, Schindhelm RK, et al. One in five laboratories using various hemoglobin A1c methods do not meet the criteria for optimal diabetes care management. Diabetes Technol Ther, 2011, 13(4): 429-433.

West China Medical Journal

糖化血红蛋白检测结果的置信区间

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