Screening of Microalbuminuria Using a Semi-quantitative UACR Test

Seoul National University

Status: Completed

Conditions: Diabetes; Microalbuminuria

Treatments: Diagnostic Test: semi-quantitative urine albumin-to-creatinine ratio test; Diagnostic Test: standard quantitative spot urine albumin-to-creatinine ratio

Study type: Observational

Funder types: Other

Identifiers

NCT03238547

URiSCAN_SNU_01

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diabetes

Exclusion criteria

• microscopic hematuria
• pyuria
• urinary cast

Trial design

1,000 participants in 1 patient group

diabetes

Description:

Diabetes patients with normal renal function and normal urinalysis

Treatment:

Diagnostic Test: standard quantitative spot urine albumin-to-creatinine ratio

Diagnostic Test: semi-quantitative urine albumin-to-creatinine ratio test