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六个国际实验室之间尿草酸盐测量的可变性。

Variability in urinary oxalate measurements between six international laboratories.

机构信息

Department of Internal Medicine, University of Texas, Southwestern Medical Center, Dallas, TX, USA.

出版信息

Nephrol Dial Transplant. 2011 Dec;26(12):3954-9. doi: 10.1093/ndt/gfr147. Epub 2011 Mar 31.

Abstract

BACKGROUND

Hyperoxaluria is a major risk factor for kidney stone formation. Although urinary oxalate measurement is part of all basic stone risk assessment, there is no standardized method for this measurement.

METHODS

Urine samples from 24-h urine collection covering a broad range of oxalate concentrations were aliquoted and sent, in duplicates, to six blinded international laboratories for oxalate, sodium and creatinine measurement. In a second set of experiments, ten pairs of native urine and urine spiked with 10 mg/L of oxalate were sent for oxalate measurement. Three laboratories used a commercially available oxalate oxidase kit, two laboratories used a high-performance liquid chromatography (HPLC)-based method and one laboratory used both methods.

RESULTS

Intra-laboratory reliability for oxalate measurement expressed as intraclass correlation coefficient (ICC) varied between 0.808 [95% confidence interval (CI): 0.427-0.948] and 0.998 (95% CI: 0.994-1.000), with lower values for HPLC-based methods. Acidification of urine samples prior to analysis led to significantly higher oxalate concentrations. ICC for inter-laboratory reliability varied between 0.745 (95% CI: 0.468-0.890) and 0.986 (95% CI: 0.967-0.995). Recovery of the 10 mg/L oxalate-spiked samples varied between 8.7 ± 2.3 and 10.7 ± 0.5 mg/L. Overall, HPLC-based methods showed more variability compared to the oxalate oxidase kit-based methods.

CONCLUSIONS

Significant variability was noted in the quantification of urinary oxalate concentration by different laboratories, which may partially explain the differences of hyperoxaluria prevalence reported in the literature. Our data stress the need for a standardization of the method of oxalate measurement.

摘要

背景

高草酸尿症是肾结石形成的一个主要危险因素。尽管尿草酸测量是所有基本结石风险评估的一部分,但目前还没有标准化的测量方法。

方法

从涵盖广泛草酸浓度范围的 24 小时尿液收集样本中抽取等分试样,并将其一式两份发送至六家盲法国际实验室,用于测量草酸、钠和肌酐。在第二组实验中,将十对天然尿液和尿液中添加 10mg/L 草酸的尿液样本发送用于草酸测量。三家实验室使用市售的草酸氧化酶试剂盒,两家实验室使用高效液相色谱(HPLC)法,一家实验室同时使用这两种方法。

结果

实验室内部测量草酸的可靠性(表示为组内相关系数)在 0.808(95%置信区间:0.427-0.948)和 0.998(95%置信区间:0.994-1.000)之间变化,HPLC 法的结果较低。分析前酸化尿液样本会导致草酸浓度显著升高。实验室间可靠性的组内相关系数在 0.745(95%置信区间:0.468-0.890)和 0.986(95%置信区间:0.967-0.995)之间变化。添加的 10mg/L 草酸的回收率在 8.7±2.3 和 10.7±0.5mg/L 之间变化。总体而言,HPLC 法与基于草酸氧化酶试剂盒的方法相比,显示出更多的变异性。

结论

不同实验室在尿液草酸浓度的定量方面存在显著差异,这可能部分解释了文献中报道的高草酸尿症患病率的差异。我们的数据强调了标准化草酸测量方法的必要性。

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本文引用的文献

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Determinants of 24-hour urinary oxalate excretion.24小时尿草酸排泄的决定因素。
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