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尿白蛋白条带检测法作为一种筛选试验,在某些情况下可替代定量检测技术。

Urinary albumin strip assay as a screening test to replace quantitative technology in certain conditions.

机构信息

Clinical Laboratory, Hospital Universitario de San Juan, San Juan de Alicante, Alicante, Spain.

Department of Biochemistry and Molecular Pathology, Universidad Miguel Hernandez, Elche, Spain.

出版信息

Clin Chem Lab Med. 2018 Dec 19;57(2):204-209. doi: 10.1515/cclm-2018-0546.

Abstract

Background The clinical laboratory plays a crucial role in the diagnosis and monitoring of chronic kidney disease. The quantitative measurement of urine albumin in a spot sample, expressed as ratio per creatinine (ACR) is the most frequently used biomarker for such a purpose. Our aim was to evaluate the diagnostic performances of a strip for measuring ACR for differentiating patients who are candidates for subsequent albumin quantification, and to evaluate the economic effects of its implementation. Methods We systematically measured strip analysis when quantitative urinary albumin was requested. Semiquantitative urinary albumin was measured using a UC-3500 (Sysmex, Kobe, Japan), based on the protein error of a pH indicator. We collected and reviewed all the values of quantified urinary albumin and their corresponding results in ACR strip tests. We calculated the diagnostic indicators for ACR at different albumin and creatinine values using the quantitative ACR measurement as a "gold standard". We also studied the economic effects based on both tests prices (€1.31 for quantitative albumin plus creatinine, and €0.04 for an albumin strip). Results The study included 9148 patients (mean age 63, 46.3% men). The results at different albumin and creatinine cutoffs showed the best performance when 10 mg/L and above 50 mg/dL, respectively. Based on our results, we would have saved 3506 urine albumin and creatinine tests in the study period, corresponding to €4226.94. Conclusions The present study supports the use of the ACR strip test to identify pathological albuminuria values to be measured through quantitative methods. Considerable economic savings are possible.

摘要

背景

临床实验室在慢性肾脏病的诊断和监测中起着至关重要的作用。定量测量尿液白蛋白与肌酐的比值(ACR)是最常用于此目的的生物标志物。我们的目的是评估用于区分随后需要进行白蛋白定量患者的 ACR 条带的诊断性能,并评估其实施的经济效果。

方法

当需要定量尿液白蛋白时,我们系统地测量了条带分析。半定量尿液白蛋白使用 UC-3500(Sysmex,神户,日本)基于 pH 指示剂的蛋白质误差进行测量。我们收集并回顾了所有定量尿液白蛋白及其相应的 ACR 条带测试结果。我们使用定量 ACR 测量作为“金标准”计算了不同白蛋白和肌酐值的 ACR 诊断指标。我们还基于两种测试的价格(定量白蛋白加肌酐为 1.31 欧元,白蛋白条为 0.04 欧元)研究了经济效果。

结果

该研究纳入了 9148 名患者(平均年龄 63 岁,46.3%为男性)。在不同的白蛋白和肌酐截止值下,当分别为 10mg/L 及以上和 50mg/dL 及以上时,结果表现最佳。根据我们的结果,在研究期间,我们将节省 3506 次尿液白蛋白和肌酐测试,相当于 4226.94 欧元。

结论

本研究支持使用 ACR 条带测试来识别需要通过定量方法测量的病理性白蛋白尿值。可以节省大量的经济成本。

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