State of the Art for Measurement of Urine Albumin: Comparison of Routine Measurement Procedures to Isotope Dilution Tandem Mass Spectrometry
State of the Art for Measurement of Urine Albumin: Comparison of Routine Measurement Procedures to Isotope Dilution Tandem Mass Spectrometry
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DOI：
10.1373/clinchem.2013.210302
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发表时间：
2014-03-01
影响因子：
9.3
通讯作者：
Miller, W. Greg
中科院分区：
文献类型：
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作者：
Bachmann, Lorin M.;Nilsson, Goran;Miller, W. Greg
背景：尿白蛋白是检测和监测肾脏损害的主要生物标志物。由于使用固定的判定标准来识别值升高的患者，我们调查了常用的常规测量程序是否给出了可比的结果。方法：将17种市售尿白蛋白测定方法的结果与同位素稀释质谱（IDMS）方法进行比较。将332例慢性肾病、糖尿病、心血管疾病和高血压患者新鲜收集的非冷冻等量尿液分发给制造商，根据每个程序的使用说明进行尿白蛋白测量。冷冻等分液采用IDMS程序进行测量。误差模型用于确定不精度和偏差分量。结果：在12-30 mg/L、31-200 mg/L和201-1064 mg/L的浓度区间内，与IDMS的最大正偏偏和负偏偏的中位数差异分别为45%、37%和42%。大多数程序的偏差随浓度而变化，16个定量程序中的14个在浓度区间内超过+/- 10%。当浓度为15mg /L时，平均偏差范围为-35%至34%。高浓度样品的稀释对4个程序产生偏倚。5次手术的总CV为0.10%。由于偏倚与浓度的关系，无法估计总误差。样本特异性影响的cv为0%至15.2%。结论：偏倚是常规测量方法不一致的主要原因。因此，标准化工作将改善结果之间的一致性。偏差随浓度的变化需要制造商解决。(C) 2013年美国临床化学学会
BACKGROUND: Urine albumin is the primary biomarker for detection and monitoring of kidney damage. Because fixed decision criteria are used to identify patients with increased values, we investigated if commonly used routine measurement procedures gave comparable results.METHODS: Results from 17 commercially available urine albumin measurement procedures were investigated vs an isotope dilution mass spectrometry (IDMS) procedure. Nonfrozen aliquots of freshly collected urine from 332 patients with chronic kidney disease, diabetes, cardiovascular disease, and hypertension were distributed to manufacturers to perform urine albumin measurements according to the respective instructions for use for each procedure. Frozen aliquots were used for measurements by the IDMS procedure. An error model was used to determine imprecision and bias components.RESULTS: Median differences between the largest positive and negative biases vs IDMS were 45%, 37%, and 42% in the concentration intervals of 12-30 mg/L, 31-200 mg/L, and 201-1064 mg/L, respectively. Biases varied with concentration for most procedures and exceeded +/- 10% over the concentration interval for 14 of 16 quantitative procedures. Mean biases ranged from -35% to 34% at 15 mg/L. Dilution of samples with high concentrations introduced bias for 4 procedures. The combined CV was > 10% for 5 procedures. It was not possible to estimate total error due to dependence of bias on concentration. CVs for sample-specific influences were 0% to 15.2%.CONCLUSIONS: Bias was the dominant source of disagreement among routine measurement procedures. Consequently, standardization efforts will improve agreement among results. Variation of bias with concentration needs to be addressed by manufacturers. (C) 2013 American Association for Clinical Chemistry