一种用于即时检测环境中定量尿白蛋白与肌酐比值的试剂条装置的性能

Performance of a reagent strip device for quantitation of the urine albumin: creatinine ratio in a point of care setting.

作者信息

Parsons M, Newman D J, Pugia M, Newall R G, Price C P

机构信息

Department of Clinical Biochemistry, St. Bartholomew's, London, UK.

出版信息

Clin Nephrol. 1999 Apr;51(4):220-7.

PMID:10230554

Abstract

AIM

We have evaluated the performance of a reagent strip (Clinitek, Bayer plc, Newbury) incorporating a novel dip and read device for the quantitation of the albumin: creatinine ratio together with their individual concentrations in urine.

METHODS

The performance was compared with that of a lateral flow device for the semi-quantitation of albumin (Micral II, Roche Diagnostics, Lewes) and also a laboratory based procedure. The device employs novel methods for both analytes, using a sulphonephthalein dye binding at pH 1.5 for albumin and the peroxidase-like activity of copper creatinine complexes. The color yields of the separate reaction pads are monitored with the Clinitek 50TM bench top urine chemistry analyzer and compared to a pre-programmed calibration algorithm.

RESULTS

The imprecision of the device was assessed by observing the discrepancy between duplicates in a total of 144 urine samples collected from patients with diabetes and/or renal disease; there were 10 discrepancies in the case of the albumin estimation (6.9%), 12 in the case of the creatinine estimation (12.5%) and 23 in the case of the albumin: creatinine ratio (16.0%). In the case of the Micral II, where 96 of the urines were analyzed there were 12 discrepancies (12.5%). When considered as a two-class test for albumin with a cut off of 20 mg/L the Clinitek gave a sensitivity of 95.4% with specificity of 78.9% and a positive predictive value of 87.4%. When analyzing four urines (two controls, two patient pools) with replicate analysis on the Clinitek system we found 100% agreement for the albumin estimation, 95% for creatinine and 96.7% for the albumin: creatinine for 60 analysis within a day and 100, 95 and 97.5% on single analyses each day for 20 days for the two urine controls. The discrepant results were always within one color block. When considering the albumin: creatinine ratio with a cut off of < 30 mg/g the Clinitek gave a sensitivity of 76.3% with a specificity of 89.1% and a positive predictive value of 89.7%.

CONCLUSION

The Clinitek system provides a reliable means to screen for microalbuminuria with the opportunity of a semi-quantitative assessment when microalbuminuria is found.

摘要

目的

我们评估了一种试剂条（Clinitek，拜耳公司，纽伯里）的性能，该试剂条结合了一种新型的浸入式读数装置，用于定量尿白蛋白：肌酐比值及其各自在尿液中的浓度。

方法

将该装置的性能与一种用于白蛋白半定量的侧向流动装置（Micral II，罗氏诊断公司，刘易斯）以及一种基于实验室的检测方法进行了比较。该装置对两种分析物均采用了新方法，在pH 1.5条件下使用一种磺基酚酞染料结合白蛋白，利用铜肌酐复合物的过氧化物酶样活性检测肌酐。用Clinitek 50TM台式尿液化学分析仪监测各个反应垫的颜色产生情况，并与预编程的校准算法进行比较。

结果

通过观察从糖尿病和/或肾病患者收集的总共144份尿液样本中重复检测结果之间的差异来评估该装置的不精密度；白蛋白估计中有10个差异（6.9%），肌酐估计中有12个差异（12.5%），白蛋白：肌酐比值中有23个差异（16.0%）。在Micral II检测中，分析了96份尿液，有12个差异（12.5%）。当将Clinitek视为白蛋白的两类检测，截断值为20 mg/L时，其灵敏度为95.4%，特异性为78.9%，阳性预测值为87.4%。在用Clinitek系统对4份尿液（2份对照、2份患者混合样本）进行重复分析时，我们发现白蛋白估计的一致性为100%，肌酐为95%，白蛋白：肌酐比值为96.7%（一天内60次分析），对于两份尿液对照，每天单次分析时的一致性分别为100%、95%和97.5%（共20天）。不一致的结果始终在一个颜色块范围内。当将白蛋白：肌酐比值的截断值设为<30 mg/g时，Clinitek的灵敏度为76.3%，特异性为89.1%，阳性预测值为89.7%。