Pugia M J, Lott J A, Kajima J, Saambe T, Sasaki M, Kuromoto K, Nakamura R, Fusegawa H, Ohta Y
Diagnostics Business Group, Bayer Corporation, Elkhart, USA.
Clin Chem Lab Med. 1999 Feb;37(2):149-57. doi: 10.1515/CCLM.1999.027.
Beginning in 1974, the Japanese Ministry of Health Welfare directed the screening of schoolchildren for proteinuria. We studied their procedure and methods in 6197 school children and also evaluated a new urine dipstick that measures albumin concentrations down to about 10 mg/l and creatinine down to about 300 mg/l. We used specimens from adult in- and outpatients to test the accuracy of the dipsticks. Based on the quantitative results, we set as cutoffs < 150 mg/l for protein and < 30 mg/l for albumin as the concentrations representing "low risk." The quantitative values were assumed to be correct, and the dipstick results were judged accordingly, i.e., a dipstick protein of > or = "150" mg/l or an albumin of I "30" mg/l indicated increased risk of developing or having a genitourinary disorder. The sensitivity/specificity of the protein dipstick was 95.1%/95.5%, and the same for the albumin dipstick was 83.8%/93.8%. The cut-off for the albumin dipsticks probably should be set somewhat lower to reduce the number of false negatives and increase the sensitivity of the dipstick. When we compared the quantitative albumin to the protein dipsticks with the above cut-offs, we found the sensitivity/specificity to be 79.3%/94.4%, i.e., much like the albumin dipstick results. The many reports on the association of albuminuria and risk of renal disease recommend that screening should be done for albumin rather than protein. Based on the data from the school children, we estimate that a dipstick albumin of "30" mg/l is borderline increased risk, and that a protein dipstick of "150" mg/l is the same. If we call the dipstick "10" mg/l albumin, "30" mg/l albumin and the "150" mg/l protein results "low risk," then we estimate the prevalence of albuminuria in the school children to be about 2.1% and proteinuria to be about 4.3%. Children with these values should have a quantitative test for albumin and protein. We also tested a dipstick for creatinine and found increasing values with increasing age in both genders; the older boys had significantly higher creatinine values than the older girls and younger boys. For the albumin/creatinine ratio, we found 6028 children with a ratio of < 30 mg/g indicating low risk and 159 children with a ratio of > or = 30 mg/g indicating increased risk. The ratio may be more useful owing to the likely reduction of the number of false negatives and false positives.
从1974年开始，日本厚生省指示对学童进行蛋白尿筛查。我们研究了他们在6197名学童中的操作程序和方法，还评估了一种新的尿试纸，该试纸可测量低至约10mg/l的白蛋白浓度和低至约300mg/l的肌酐浓度。我们使用成人门诊和住院患者的样本测试尿试纸的准确性。根据定量结果，我们将蛋白质浓度<150mg/l和白蛋白浓度<30mg/l设定为代表“低风险”的临界值。假定定量值是正确的，并据此判断尿试纸结果，即尿试纸蛋白质结果>或=“150”mg/l或白蛋白结果>“30”mg/l表明发生或患有泌尿生殖系统疾病的风险增加。蛋白质尿试纸的敏感性/特异性为95.1%/95.5%，白蛋白尿试纸的敏感性/特异性为83.8%/93.8%。白蛋白尿试纸的临界值可能应设定得更低一些，以减少假阴性数量并提高尿试纸的敏感性。当我们将定量白蛋白与上述临界值的蛋白质尿试纸进行比较时，发现其敏感性/特异性为79.3%/94.4%，即与白蛋白尿试纸结果非常相似。许多关于白蛋白尿与肾脏疾病风险关联的报告建议应筛查白蛋白而非蛋白质。根据学童的数据，我们估计尿试纸白蛋白结果为“30”mg/l时风险临界升高，尿试纸蛋白质结果为“150”mg/l时情况相同。如果我们将尿试纸“10”mg/l白蛋白、“30”mg/l白蛋白和“150”mg/l蛋白质结果称为“低风险”，那么我们估计学童中白蛋白尿的患病率约为2.1%，蛋白尿的患病率约为4.3%。有这些值的儿童应进行白蛋白和蛋白质的定量检测。我们还测试了肌酐尿试纸，发现两性的肌酐值均随年龄增长而升高；年龄较大的男孩肌酐值明显高于年龄较大的女孩和年龄较小的男孩。对于白蛋白/肌酐比值，我们发现6028名儿童的比值<30mg/g表明风险低，159名儿童的比值>或=30mg/g表明风险增加。由于可能减少假阴性和假阳性数量，该比值可能更有用。
