Measurement of HbA1c from stored whole blood samples in the Atherosclerosis Risk in Communities study
Measurement of HbA1c from stored whole blood samples in the Atherosclerosis Risk in Communities study
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DOI：
10.1111/j.1753-0407.2010.00070.x
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发表时间：
2010-06-01
影响因子：
4.5
通讯作者：
Steffes, Michael W.
中科院分区：
文献类型：
--
作者：
Selvin, Elizabeth;Coresh, Josef;Steffes, Michael W.
背景：本研究的目的是证明HbA1c在两个时间段的测量的可靠性，并将这些测量结果与HbA1c在美国普通人群中的分布进行比较。方法：在社区动脉粥样硬化风险(ARIC)研究中，使用不同的高效液相仪器在两个时间段，即2003-2004年和2007-2008年，测量了14069份全血样本的HbA1c。在测量时，样品已经在零下70摄氏度储存了长达18年。为了评估数值的差异，在两个时期对383个样本进行了HbA1c重复测量。结果：2003-2004年质控样品的变异系数为1.8%(n=)，2007-2008年的变异系数为1.4%(n=259)。两个时间点的测量结果之间的相关性很高(r=0.99)，但略有偏差：2007年至2008年比2003年至2004年高0.29%(n=383；P<；0.0001)。经比较得出戴明回归方程为：y((2007年-2008年))=0.073+1.034x((2003年-2004年))。用此方程对齐后，ARIC研究中HbA1c的分布与使用新鲜样本的全国研究中的HbA1c分布相似。结论：使用最先进的高效液相仪器测量储存长达18年的HbA1c是高度可靠的，但随着时间的推移会产生一些偏差。目前在ARIC研究中可获得的HbA1c数据对于研究HbA1c作为糖尿病诊断试验的临床实用性应该是非常有价值的。
Background: The aims of the present study were to demonstrate the reliability of HbA1c measurements during two time periods and to compare these measurements with HbA1c distribution in the general US population.Methods: HbA1c was measured in 14 069 whole blood samples in the Atherosclerosis Risk in Communities (ARIC) study using different HPLC instruments across two time periods, namely 2003-2004 and 2007-2008. At the time of measurement, samples had been in storage at) -70 degrees C for up to 18 years. To assess differences in values, HbA1c measurements were repeated in 383 samples at both periods. Indirect comparisons were made by comparing our measurements against those from a nationally representative study.Results: The coefficients of variation for quality control samples were 1.8% (n = 89) in 2003-2004 and 1.4% (n = 259) in 2007-2008. The correlation between measurements at the two time points was high (r = 0.99), but with a slight bias: 0.29% points higher in 2007-2008 vs 2003-2004 (n = 383; P < 0.0001). The comparison yielded the following Deming regression equation: y((2007-2008)) = 0.073 + 1.034x((2003- 2004)). After alignment using this equation, the distribution of HbA1c in the ARIC study was similar to that in the national study using fresh samples.Conclusions: Measurements of HbA1c from samples stored for up to 18 years are highly reliable when using state-of-the-art HPLC instruments, but with some bias introduced over time. The HbA1c data now available in the ARIC study should be invaluable for investigations into the clinical utility of HbA1c as a diagnostic test for diabetes.