NCT03238547

Screening of Microalbuminuria Using a Semi-quantitative UACR Test

Accuracy of a Semi-quantitative Urine Albumin-to-creatinine Ratio Test as a Screening Tool for Microalbuminuria in Patients With Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Microalbuminuria

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	semi-quantitative urine albumin-to-creatinine ratio test	measurement of urine albumin-to-creatinine ratio using URiSCAN 2ACR, a semi-quantitative urine albumin-to-creatinine ratio test
DIAGNOSTIC_TEST	standard quantitative spot urine albumin-to-creatinine ratio	measurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-08-03
• Last updated: 2020-03-25

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study