Fernández Fernández I, Páez Pinto J M, Hermosín Bono T, Vázquez Garijo P, Ortiz Camuñez M A, Tarilonte Delgado M A
Centro de Salud de Camas, Seville, Spain.
Acta Diabetol. 1998 Dec;35(4):199-202. doi: 10.1007/s005920050131.
Microalbuminuria predicts clinical nephropathy and cardiovascular disease in diabetes mellitus. This study was undertaken to evaluate a screening microalbuminuria test with the Micral test II dipstick in a general practice setting and compare whether, if three urine samples are tested, any advantage is offered over a testing single sample. Two hundred and eighty diabetic patients attending a primary health care centre were studied. The first morning urine albumin concentration was determined by dipstick over 3 consecutive days. We studied two valuation methods: Method 1. Three-sample method: the test was considered positive if albumin was equal to or above 20 mg/l in at least two of three tests; Method 2. Single-sample method: we selected the third test, i.e. the most recent urine sample; if albumin was equal to or above 20 mg/l it was considered positive. The gold standard was the albumin excretion rate measured by a nephelometric method in a 24-h urine collection. Sensitivity, specificity, predictive values and Kappa coefficient were calculated. The diagnostic performance was assessed by a receiver operating characteristic curve. Microalbuminuria was defined for different thresholds of albumin excretion rate, 15, 20, 25 and 30 microg/min: their frequency was 38, 29, 23 and 18%, respectively. For method 1, the sensitivity of Micral test II oscillated between 70-94% and the specificity between 93-83%. For method 2, the sensitivity oscillated between 64-86%, and the specificity between 88-80%. Both methods had a high diagnostic performance. The Kappa coefficient was 84 and 60% for method 1 and 2, respectively. The Micral test II is a rapid, valid and reliable method for microalbuminuria screening in diabetic patients. It constitutes an important tool for diabetic surveillance in general practice. Although the use of three samples provides better results, the use of a single sample produces acceptable results at a low cost.
微量白蛋白尿可预测糖尿病患者的临床肾病和心血管疾病。本研究旨在评估在基层医疗环境中使用Micral test II试纸条进行微量白蛋白尿筛查试验，并比较检测三份尿液样本是否比检测单份样本具有任何优势。对280名到初级保健中心就诊的糖尿病患者进行了研究。连续3天通过试纸条测定晨尿白蛋白浓度。我们研究了两种评估方法：方法1. 三份样本法：如果三份检测中至少两份的白蛋白等于或高于20mg/l，则该检测被视为阳性；方法2. 单份样本法：我们选择第三次检测，即最近的尿液样本；如果白蛋白等于或高于20mg/l，则被视为阳性。金标准是通过比浊法测定24小时尿白蛋白排泄率。计算了灵敏度、特异度、预测值和Kappa系数。通过受试者工作特征曲线评估诊断性能。针对白蛋白排泄率的不同阈值15、20、25和30μg/min定义微量白蛋白尿：其频率分别为38%、29%、23%和18%。对于方法1，Micral test II的灵敏度在70%-94%之间波动，特异度在93%-83%之间波动。对于方法2，灵敏度在64%-86%之间波动，特异度在88%-80%之间波动。两种方法都具有较高的诊断性能。方法1和方法2的Kappa系数分别为84%和60%。Micral test II是糖尿病患者微量白蛋白尿筛查的一种快速、有效且可靠的方法。它是基层医疗中糖尿病监测的重要工具。虽然使用三份样本能提供更好的结果，但使用单份样本以低成本也能产生可接受的结果。
