不同方法检测缺铁性贫血患者糖化血红蛋白A1c的一致性
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中山市科技计划项目(20122A034,20132A091)。


Consistency of test results of glycosylated hemoglobin A1c with different methods in iron deficiency anemia patients
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    摘要:目的:观察不同方法检测缺铁性贫血(IDA)患者糖化血红蛋白A1c(HbA1c)的一致性。 方法:参照美国国家糖化血红蛋白标准化计划(NGSP)认证Ⅰ级实验室要求,以通过NGSPⅠ级实验室认证的VariantⅡ检测系统为参考系统,以分别代表离子交换高效液相色谱法(IE-HPLC)、酶法、免疫比浊法和亲和层析高效液相色谱法(AC-HPLC)的VariantⅡ Turbo、Modular P、Leadman、Primus Ultra2检测系统为实验系统,用20份健康体检者和20例糖尿病(DM)患者的HbA1c浓度范围为4.2%~14.6%的样品进行比对;再以通过比对的4个检测系统和VariantⅡ检测系统检测20例IDA患者和20例IDA合并DM患者样品并对检测系统间的数据进行直线回归分析。 结果:5个检测系统检测20例IDA患者和20例IDA合并DM患者样品,直线回归分析斜率范围为0.973 0~1.023 1,r2范围为0.995 5~0.998 1,偏差的95%CI的最大范围为-0.48%~0.48%、百分偏差的最大范围为-5.62%~5.95%。 结论:IDA患者HbA1c水平用不同检测方法可获得一致的检测结果。

    Abstract:

    Abstract: Objective:To investigate the consistency of test results of glycosylated hemoglobin A1c(HbA1c) with different methods in iron deficiency anemia patients. Methods:According to the requirements of National Glycohemoglobin Standardisation Program (NGSP) certification grade Ⅰ laboratory, Variant Ⅱ detection system was certified as the reference system, and variant Ⅱ Turbo, Modular P, Leadman and Primus Ultra2 were used as the comparison system, which represented the ion exchange high performance liquid chromatography (IE-HPLC), enzyme method, immune turbidimetry and affinity chromatography and high performance liquid chromatography (AC-HPLC), respectively. The samples of 20 healthy individuals and of 20 patients with diabetes melitus (DM) in which the concentration of glycosylated hemoglobin A1c ranged from 4.2% to14.6% were detected and the results were compared. The four Variant Ⅱ detection systems which passed the comparison were used as the experimental system to determine the concentrations of HbA1c in the samples of 20 patients with iron deficient anemia (IDA) and of 20 patients with IDA complicated merged diabetes mellitus (DM). The data were assessed by multiple linear regression analysis. Results:The data of the four comparison system showed approving consistency with the reference system. The test results of 20 patients with IDA and 20 patients with IDA merged DM were as follows: slope of linear regression analysis was from 0.973 0 to 1.023 1, correlation coefficient was from 0.995 5 to 0.998 1. The maximum range of the 95% confidence interval deviation was from -0.48% to 0.48% and the maximum range of the percentage deviation was from -5.62% to 5.95%. Conclusion:For IDA patients, consistent results of HbA1c may obtain from different detection system.

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徐全中,温冬梅,张秀明,吴剑杨,李曼,索明环,阚丽娟,萧金丽,胡婷,徐胜男,庞嘉琳.不同方法检测缺铁性贫血患者糖化血红蛋白A1c的一致性[J].临床检验杂志,2015,(5):385-387

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  • 收稿日期:2015-01-24
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  • 在线发布日期: 2015-07-22
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