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尿液分析试纸条的定量评估。

Quantitative evaluation of urinalysis test strips.

作者信息

Penders Joris, Fiers Tom, Delanghe Joris R

机构信息

Department of Clinical Chemistry University Hospital Ghent, De Pintelaan 185, B-9000 Ghent, Belgium.

出版信息

Clin Chem. 2002 Dec;48(12):2236-41.

PMID:12446482
Abstract

BACKGROUND

Urine test strip results are generally reported in categories (i.e., ordinal scaled), but automated strip readers are now available that can report quantitative data. We investigated the possible use of these meters to complement flow cytometry of urine and compared reflectance readings with quantitative determinations of urinary glucose and microalbumin.

METHODS

We compared URISYS 2400 (Roche) quantitative reflectance data with data from the UF-100 (Sysmex) and biochemical data for 436 nonpathologic and pathologic urine samples.

RESULTS

Reproducibility of the reflectance signal was good for high- and low-concentration urine pools for protein (0.8% and 0.9% and 1.5% and 2.2% within and between runs, respectively), leukocyte esterase (1.1% and 1.0%; 5.1% and 1.2%), hemoglobin (1.7% and 1.1%; 8.9% and 1.1%) and glucose (2.1% and 0.5%; 6.5% and 2.3%). Fair agreement was obtained between UF-100 and test strip reflectance data for erythrocytes and hemoglobin (r = -0.680) and leukocytes and leukocyte esterase (r = -0.688). Higher correlations were observed for biochemical and test strip data comparing protein and albumin (r = -0.825) and glucose data (r = -0.851). The lower limits of detection for erythrocytes and leukocytes were 8 x 10(6)/L and 19 x 10(6)/L, respectively. The protein test (n = 220) detected 86% (95% confidence interval, 78-92%) of samples with <30 mg/L albumin with a specificity of 84% (95% confidence interval, 76-91%).

CONCLUSIONS

In urine test strip analysis, quantitative hemoglobin and leukocyte esterase reflectance data are complementary with flow cytometric results and glucose and albumin results.

摘要

背景

尿试纸条结果通常以类别形式报告(即有序尺度),但现在已有能报告定量数据的自动试纸条读取器。我们研究了这些仪器用于补充尿流式细胞术的可能性,并将反射率读数与尿葡萄糖和微量白蛋白的定量测定结果进行了比较。

方法

我们将URISYS 2400(罗氏公司)的定量反射率数据与UF - 100(希森美康公司)的数据以及436份非病理性和病理性尿样的生化数据进行了比较。

结果

对于高浓度和低浓度尿样池,蛋白质反射率信号的重复性良好(批内分别为0.8%和0.9%,批间分别为1.5%和2.2%),白细胞酯酶(1.1%和1.0%;5.1%和1.2%),血红蛋白(1.7%和1.1%;8.9%和1.1%)以及葡萄糖(2.1%和0.5%;6.5%和2.3%)。UF - 100与试纸条红细胞和血红蛋白反射率数据(r = -0.680)以及白细胞和白细胞酯酶反射率数据(r = -0.688)之间一致性尚可。在比较蛋白质和白蛋白(r = -0.825)以及葡萄糖数据(r = -0.851)时,生化数据与试纸条数据之间观察到更高的相关性。红细胞和白细胞的检测下限分别为8×10⁶/L和19×10⁶/L。蛋白质检测(n = 220)在白蛋白<30 mg/L的样本中检测出86%(95%置信区间,78 - 92%),特异性为84%(95%置信区间,76 - 91%)。

结论

在尿试纸条分析中,定量血红蛋白和白细胞酯酶反射率数据与流式细胞术结果以及葡萄糖和白蛋白结果具有互补性。

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