Molinario Rossana, Pocino Krizia, Daloiso Pio Dante, Giannace Angela, Spirito Giulia, Zuppi Cecilia, Antenucci Mirca
Department of Clinical Biochemistry, "A. Gemelli" Policlinico Universitario, Rome, Italy.
J Clin Lab Anal. 2016 Nov;30(6):888-891. doi: 10.1002/jcla.21952. Epub 2016 Apr 7.
Monitoring urinary albumin is a useful method in clinical practice for the management of diabetic nephropathy, chronic kidney disease, and hypertension. Currently there are neither standardized methods nor reference material for the determination of urinary albumin; for this reason it is useful to compare different assays used in clinical laboratory.
The aim of this study is to verify analytical performance of an immunoturbidimetric assay on Roche Cobas 8000 platform and to compare urinary albumin results with those obtained by immunonephelometry on Siemens Dade Behring BN II Nephelometer.
The method comparison showed a good linear relationship, confirmed by Passing-Bablok and Bland-Altman plots. The turbidimetric assay meets the requirements of accuracy and precision for the practice of medical diagnostics and clinical use.
The present study can contribute to the methods standardization and harmonization of urinary albumin assay.
监测尿白蛋白是临床实践中管理糖尿病肾病、慢性肾脏病和高血压的一种有用方法。目前,尿白蛋白测定既没有标准化方法,也没有参考物质;因此,比较临床实验室使用的不同检测方法很有必要。
本研究旨在验证罗氏Cobas 8000平台上免疫比浊法的分析性能,并将尿白蛋白检测结果与西门子德灵BN II特定蛋白分析仪上免疫散射比浊法的检测结果进行比较。
方法比较显示出良好的线性关系,经帕氏-巴布洛克法和布兰德-奥特曼图证实。比浊法满足医学诊断和临床应用实践中的准确性和精密度要求。
本研究有助于尿白蛋白检测方法的标准化和统一。