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Microalbuminuria is an important biomarker for the development of diabetic nephropathy and cardiovascular complications. Since microalbuminuria is not easily detected on routine urinalysis, current guidelines recommend measuring spot urine albumin-to-creatinine ratio (uACR) annually in a patient with diabetes mellitus. While the standard method is quantitative measurement using turbidimetric immunoassay, it requires high cost and special laboratory equipment. This may be a hurdle that prevents screening for microalbuminuria in many patients with diabetes. Therefore, a semi-quantitative uACR test, which is rapid and inexpensive, could be used as a substitute to the current standard quantitative measurement. The investigators aimed to assess the diagnostic accuracy of a semi-quantitative urine albumin-to-creatinine ratio test, URiSCAN 2ACR, as a screening tool for microalbuminuria in patients with diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diabetes | Diabetes patients with normal renal function and normal urinalysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semi-quantitative urine albumin-to-creatinine ratio test | Diagnostic Test | measurement of urine albumin-to-creatinine ratio using URiSCAN 2ACR, a semi-quantitative urine albumin-to-creatinine ratio test |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Sensitivity and Specificity | Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method | through study completion, an average of 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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diabetic patients following Seoul National University Hospital
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| standard quantitative spot urine albumin-to-creatinine ratio | Diagnostic Test | measurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay |
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