五种尿白蛋白测量方法的方法学评估和比较。
Methodological evaluation and comparison of five urinary albumin measurements.
机构信息
College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, People's Republic of China.
出版信息
J Clin Lab Anal. 2011;25(5):324-9. doi: 10.1002/jcla.20477.
BACKGROUND
Microalbuminuria is an indicator of kidney damage and a risk factor for the progression kidney disease, cardiovascular disease, and so on. Therefore, accurate and precise measurement of urinary albumin is critical. However, there are no reference measurement procedures and reference materials for urinary albumin.
METHODS
Nephelometry, turbidimetry, colloidal gold method, radioimmunoassay, and chemiluminescence immunoassay were performed for methodological evaluation, based on imprecision test, recovery rate, linearity, haemoglobin interference rate, and verified reference interval. Then we tested 40 urine samples from diabetic patients by each method, and compared the result between assays.
RESULTS
The results indicate that nephelometry is the method with best analytical performance among the five methods, with an average intraassay coefficient of variation (CV) of 2.6%, an average interassay CV of 1.7%, a mean recovery of 99.6%, a linearity of R=1.00 from 2 to 250 mg/l, and an interference rate of <10% at haemoglobin concentrations of <1.82 g/l. The correlation (r) between assays was from 0.701 to 0.982, and the Bland-Altman plots indicated each assay provided significantly different results from each other.
CONCLUSION
Nephelometry is the clinical urinary albumin method with best analytical performance in our study.
背景
微量白蛋白尿是肾脏损伤的一个指标，也是肾脏疾病、心血管疾病等进展的一个危险因素。因此，准确和精确的尿白蛋白测量至关重要。然而，目前还没有用于尿白蛋白的参考测量程序和参考物质。
方法
基于不精密度试验、回收率、线性、血红蛋白干扰率和验证参考区间，对散射比浊法、透射比浊法、胶体金法、放射免疫法和化学发光免疫法进行方法学评价。然后，我们用每种方法检测了 40 例糖尿病患者的尿液样本，并比较了检测结果。
结果
结果表明，在这 5 种方法中，散射比浊法的分析性能最好，其平均日内变异系数（CV）为 2.6%，平均日间 CV 为 1.7%，平均回收率为 99.6%，线性范围为 2 至 250mg/L，R=1.00，血红蛋白浓度<1.82g/L 时的干扰率<10%。检测之间的相关性（r）为 0.701 至 0.982，Bland-Altman 图表明，每种检测方法之间的结果存在显著差异。
结论
在我们的研究中，散射比浊法是具有最佳分析性能的临床尿白蛋白检测方法。
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