Pfab T, Franz U, Herfeld F, Lun A, Armbruster F, Hocher B
Center for Cardiovascular Research / Institute of Pharmacology, Charité-Universitatsmedizin Berlin, Germany.
Eur J Med Res. 2006 Jan 31;11(1):3-6.
Albuminuria is a powerful predictor of cardiovascular events in diabetic and hypertensive patients as well as in the general population. In the present study we evaluated the diagnostic performance of the new PreventID Albumin test, a semi-quantitative immunochromatographic dipstick device for the rapid detection of low concentrations of urinary albumin (microalbuminuria). 88 randomly selected fresh urine samples from the central clinical laboratory of the Charité, Berlin/Germany were analysed. The diagnostic accuracy of the PreventID Albumin test for the detection of urinary albumin excretion >18 mg/l was assessed by comparing the results with urinary albumin excretion determined by immunoturbidimetry as golden standard. In comparison with immunoturbidimetry the PreventID Albumin test had a sensitivity of 96.2% and specificity of 97.1%. False negative results were found in 2.3% and false positive results were obtained in 1.1% of specimens. These findings suggest that the PreventID Albumin test may be a useful and valid method for the screening of albuminuria. However, it should not be regarded as a diagnostic test. Positive results should be followed by quantification of urinary albumin or albumin/creatinine ratio by a laboratory based method.
蛋白尿是糖尿病患者、高血压患者以及普通人群心血管事件的有力预测指标。在本研究中,我们评估了新型PreventID白蛋白检测的诊断性能,这是一种用于快速检测低浓度尿白蛋白(微量白蛋白尿)的半定量免疫层析试纸条装置。对从德国柏林夏里特医院中心临床实验室随机选取的88份新鲜尿液样本进行了分析。通过将结果与以免疫比浊法测定的尿白蛋白排泄量作为金标准进行比较,评估了PreventID白蛋白检测对检测尿白蛋白排泄量>18 mg/l的诊断准确性。与免疫比浊法相比,PreventID白蛋白检测的灵敏度为96.2%,特异性为97.1%。在2.3%的标本中发现假阴性结果,在1.1%的标本中获得假阳性结果。这些发现表明,PreventID白蛋白检测可能是一种用于筛查蛋白尿的有用且有效的方法。然而,它不应被视为诊断试验。阳性结果之后应通过基于实验室的方法对尿白蛋白或白蛋白/肌酐比值进行定量。