Webb D J, Newman D J, Chaturvedi N, Fuller J H
Eurodiab, Department of Epidemiology and Public Health, University College London, UK.
Diabetes Res Clin Pract. 1996 Mar;31(1-3):93-102. doi: 10.1016/0168-8227(96)01208-9.
In IDDM, microalbuminuria (urinary albumin excretion rate (AER) of 20-200 micrograms/min) is a predictor of persistent proteinuria and diabetic nephropathy. Early intervention may prevent or reduce the rate of progression of renal complications. The Micral-Test strip can be used to establish a semi-quantitative estimate of AER. We assessed the field performance of the Micral-Test strip in detecting microalbuminuria in the EUCLID study, an European wide, 18 centre study of 530 IDDM participants, aged 20 to 59 years. People with macroalbuminuria were excluded. On entry, all participants had albumin concentrations from two overnight urine collections measured by a central laboratory, and the corresponding Micral-Test performed on the two collections locally. a cut off of > or = mg/l albumin from the first Micral-Test, to detect a centrally measured albumin concentration > or = 20 mg/l, yielded 29 (5.8%) false negative results and 58 (11.6%) false positive results (sensitivity 70%, specificity 87%). The mean AER, from two collections, was compared with the corresponding 'pooled' Micral-Test results (mean of the two readings). Receiver Operating Characteristic (ROC) curves were used to assess if there was a suitable 'pooled' Micral-Test result for screening microalbuminuria. A 'pooled' Micral-Test result (> or = 15 mg/l) was used to detect mean AER > or = 20 micrograms/min (sensitivity 78%, specificity 77%). This 'pooled cut-off' had already been used for screening on to the study and led to an over-estimate (154 vs. 77) of the true number of microalbuminuric participants on the study. In conclusion, our findings suggest that the Micral-Test strip is not an effective screening tool for microalbuminuria, using the 'pooled' result from two measurements did not improve the sensitivity of the test.
在胰岛素依赖型糖尿病（IDDM）中，微量白蛋白尿（尿白蛋白排泄率（AER）为20 - 200微克/分钟）是持续性蛋白尿和糖尿病肾病的一个预测指标。早期干预可能预防或降低肾脏并发症的进展速度。Micral-Test试纸条可用于对AER进行半定量估计。在EUCLID研究中，我们评估了Micral-Test试纸条在检测微量白蛋白尿方面的现场表现。EUCLID研究是一项在欧洲范围内开展的、涉及18个中心的研究，共有530名年龄在20至59岁的IDDM参与者。大量白蛋白尿患者被排除在外。入组时，所有参与者均由中心实验室测量两次过夜尿液收集样本中的白蛋白浓度，并在当地对这两份样本进行相应的Micral-Test检测。首次Micral-Test检测中白蛋白浓度≥mg/l，以检测中心测量的白蛋白浓度≥20 mg/l，产生了29例（5.8%）假阴性结果和58例（11.6%）假阳性结果（灵敏度70%，特异性87%）。将两次收集样本的平均AER与相应的“合并”Micral-Test结果（两次读数的平均值）进行比较。采用受试者工作特征（ROC）曲线来评估是否存在适合筛查微量白蛋白尿的“合并”Micral-Test结果。使用“合并”Micral-Test结果（≥15 mg/l）来检测平均AER≥20微克/分钟（灵敏度78%，特异性77%）。这个“合并临界值”已用于该研究的筛查，导致对研究中微量白蛋白尿参与者的真实数量估计过高（154对77）。总之，我们的研究结果表明，Micral-Test试纸条不是检测微量白蛋白尿的有效筛查工具，使用两次测量的“合并”结果并未提高检测的灵敏度。
