Diagnostic Accuracy of Urine Dipsticks for Detection of Albuminuria in the General Community
Diagnostic Accuracy of Urine Dipsticks for Detection of Albuminuria in the General Community
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DOI：
10.1053/j.ajkd.2010.12.026
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发表时间：
2011-07-01
影响因子：
13.2
通讯作者：
Chadban, Steven J.
中科院分区：
文献类型：
--
作者：
White, Sarah L.;Yu, Richard;Chadban, Steven J.
背景：尿试纸是一种廉价的蛋白尿检测方法，被广泛提倡用于大规模筛查；然而，它们在普通社区的诊断准确性在很大程度上是未知的。研究设计：在横断面队列中评估诊断测试的准确性。背景和参与者：AusDiab，一项针对25岁及以上澳大利亚成年人的代表性调查（于1999/2000年进行）。对参加生物医学检查的11247人进行分层整群随机抽样；完整的尿液分析数据为10,944。指标试验：尿试纸（拜耳Multistix），阳性结果定义为>= 1+或微量或更高蛋白质。参考试验：白蛋白-肌酐比（ACR），在随机点尿样上测量。参考试验阳性定义为ACR >= 30 mg/g或ACR >= 300 mg/g。结果：ACR = 300 mg/g的受试者人数分别为10219（93.4%）、634（5.8%）和91（0.8%）。试纸检测ACR bb0 = 30 mg/g时，男性受试者工作特征曲线下面积（AUC）为0.8451 +/- 0.0129 (SE)，女性受试者为0.7775 +/- 0.0131 （P < 0.001）。试纸检测ACR bb0 = 300 mg/g的AUROC男性为0.9904 +/- 0.0030，女性为0.9950 +/- 0.0016 （P = 0.02）。试验结果>= 1+鉴定ACR >= 30 mg/g，灵敏度为57.8% (95% CI, 54.1% ~ 61.4%)，特异性为95.4% (95% CI, 95.0% ~ 95.8%)；鉴定ACR >= 300 mg/g，灵敏度为98.9% (99% CI, 92.1% ~ 100%)，特异性为92.6% （99% CI, 92.0% ~ 93.3%）。测定微量及以上ACR >= 30 mg/g，灵敏度69.4% (95% CI, 65.9% ~ 72.7%)，特异性86.8% (95% CI, 86.1% ~ 87.4%)；测定ACR >= 300 mg/g，灵敏度100% (99% CI, 94.3% ~ 100%)，特异性83.7% （99% CI, 82.8% ~ 84.6%）。对于ACR >= 30 mg/g，试尺阴性结果（小于微量）的阴性预测值为97.6% (95% CI, 97.2%-97.9%)，对于ACR >= 300 mg/g，阴性预测值为100% （99% CI, 99.9%-100%）。实验室调查证实ACR >= 30 mg/g的概率为47.2% (95% CI, 43.9%-50.5%)，基于量尺结果>= 1+和基于痕量或更高结果的27.1% （95% CI, 25.1%-29.2%）。局限性：分离的尿液样本无法评估试验的可重复性。不记录尿比重和pH值；因此，没有评估尿浓度对测试成绩的影响。结论：试纸试验结果
Background: Urine dipsticks, an inexpensive accessible test for proteinuria, are widely advocated for mass screening; however, their diagnostic accuracy in the general community is largely unknown.Study Design: Evaluation of diagnostic test accuracy in a cross-sectional cohort.Setting & Participants: AusDiab, a representative survey of Australian adults 25 years and older (conducted in 1999/2000). Stratified cluster random sampling from 11,247 individuals participating in the biomedical examination; complete urinalysis data available for 10,944.Index Test: Urine dipsticks (Bayer Multistix), with a positive result defined as >= 1+ or trace or higher protein.Reference Test: Albumin-creatinine ratio (ACR), measured on a random spot urine sample. Reference test positivity was defined as ACR >= 30 mg/g or ACR >= 300 mg/g.Results: Numbers of participants with ACR = 300 mg/g were 10,219 (93.4%), 634 (5.8%), and 91 (0.8%), respectively. The area under the receiver operating characteristic curve (AUC) for dipstick detection of ACR >= 30 mg/g was 0.8451 +/- 0.0129 (SE) in men and 0.7775 +/- 0.0131 in women (P < 0.001). The AUROC for dipstick detection of ACR >= 300 mg/g was 0.9904 +/- 0.0030 in men and 0.9950 +/- 0.0016 in women (P = 0.02). Dipstick result >= 1+ identified ACR >= 30 mg/g with 57.8% sensitivity (95% CI, 54.1%-61.4%) and 95.4% specificity (95% CI, 95.0%-95.8%) and identified ACR >= 300 mg/g with 98.9% sensitivity (99% CI, 92.1%-100%) and 92.6% specificity (99% CI, 92.0%-93.3%). A dipstick result of trace or higher identified ACR >= 30 mg/g with 69.4% sensitivity (95% CI, 65.9%-72.7%) and 86.8% specificity (95% CI, 86.1%-87.4%) and identified ACR >= 300 mg/g with 100% sensitivity (99% CI, 94.3%-100%) and 83.7% specificity (99% CI, 82.8%-84.6%). A negative dipstick result (less than trace) had a negative predictive value of 97.6% (95% CI, 97.2%-97.9%) for ACR >= 30 mg/g and a negative predictive value of 100% (99% CI, 99.9%-100%) for ACR >= 300 mg/g. The probability of an ACR >= 30 mg/g confirmed on laboratory investigation was 47.2% (95% CI, 43.9%-50.5%) based on a dipstick result >= 1+ and 27.1% (95% CI, 25.1%-29.2%) based on a trace or higher result.Limitations: Isolated urine samples precluded assessment of test reproducibility. Urine specific gravity and pH were not recorded; therefore, the effect of urine concentration on test performance was not assessed.Conclusions: A dipstick test result