Accuracy of a Semi-quantitative Urine Albumin-to-creatinine Ratio Test as a Screening Tool for Microalbuminuria in Patients With Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Seoul National University Hospital
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Diagnostic Sensitivity and Specificity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Dong Ki Kim
Prof.
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •microscopic hematuria
- •urinary cast
Outcomes
Primary Outcomes
Diagnostic Sensitivity and Specificity
Time Frame: through study completion, an average of 18 months
Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method