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尿试纸检测在 2 型糖尿病微量白蛋白尿筛查中的诊断准确性:初级保健中的队列研究。

Diagnostic accuracy of urine dipstick testing in screening for microalbuminuria in type 2 diabetes: a cohort study in primary care.

机构信息

Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

出版信息

Fam Pract. 2013 Apr;30(2):142-52. doi: 10.1093/fampra/cms057. Epub 2012 Sep 17.

Abstract

BACKGROUND

Clinical guidelines recommend annual screening for microalbuminuria in diabetes. Detection of microalbuminuria is important because it is associated with increased morbidity and mortality. Dipstick tests for microalbuminuria may be convenient, but their accuracy is uncertain.

OBJECTIVE

To assess the utility of urine dipstick testing for microalbuminuria in type 2 diabetes.

METHODS

In a 6-week cohort study in four general practices in Oxfordshire, UK, first-pass urine samples were obtained at two weekly intervals from patients with type 2 diabetes and tested in the practice using Micral-Test and Microalbustix urine dipsticks. Parallel samples were sent for laboratory albumin-creatinine ratio (ACR) assay. Results of single dipstick tests and sequences of dipstick and laboratory tests were compared with a clinical testing strategy based on current guidelines to assess the accuracy and estimate costs of testing.

RESULTS

The prevalence of microalbuminuria was 12.5% (n = 88). Mean (standard deviation) age was 68 (10) years, 56 (57%) were men. Median (interquartile range) diabetes duration was 6.2 (2.0-10.0) years. The sensitivity and specificity, respectively, of a single Micral-Test were 91.7% and 44.0% and of a Microalbustix test 33.3% and 92.0%. Testing strategies involving dipstick and laboratory ACR measurements or dipstick tests had similar accuracy. The costs of using dipstick tests were overall lower than laboratory ACR-based testing.

CONCLUSIONS

Dipstick testing in this study did not reliably identify diabetes patients with microalbuminuria. Although dipstick testing would decrease testing costs, it could either fail to diagnose most patients with microalbuminuria or increase the numbers of patients retested depending on the dipstick used.

摘要

背景

临床指南建议每年对糖尿病患者进行微量白蛋白尿筛查。检测微量白蛋白尿很重要,因为它与发病率和死亡率的增加有关。用于检测微量白蛋白尿的尿试纸可能很方便,但它们的准确性不确定。

目的

评估尿试纸检测 2 型糖尿病微量白蛋白尿的效用。

方法

在英国牛津郡的四家全科医生诊所进行的 6 周队列研究中,每两周从 2 型糖尿病患者中获得一次初始尿液样本,并在诊所使用 Micral-Test 和 Microalbustix 尿试纸进行检测。平行样本被送到实验室进行白蛋白-肌酐比(ACR)测定。单试纸检测结果和试纸与实验室检测序列与基于当前指南的临床检测策略进行比较,以评估检测的准确性并估算检测成本。

结果

微量白蛋白尿的患病率为 12.5%(n=88)。平均(标准差)年龄为 68(10)岁,56 人(57%)为男性。中位(四分位间距)糖尿病病程为 6.2(2.0-10.0)年。单个 Micral-Test 的灵敏度和特异性分别为 91.7%和 44.0%,Microalbustix 检测的灵敏度和特异性分别为 33.3%和 92.0%。涉及试纸和实验室 ACR 测量或试纸检测的检测策略具有相似的准确性。使用试纸检测的总体成本低于基于实验室 ACR 的检测。

结论

本研究中的试纸检测不能可靠地识别出患有微量白蛋白尿的糖尿病患者。尽管试纸检测可以降低检测成本,但根据所使用的试纸,它要么无法诊断大多数微量白蛋白尿患者,要么增加需要重新检测的患者数量。

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