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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03238547

Enrollment

1000

Registered

2017-08-03

Start date

2017-08-01

Completion date

2019-12-31

Last updated

2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Microalbuminuria

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.

Interventions

DIAGNOSTIC_TESTsemi-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_TESTstandard quantitative spot urine albumin-to-creatinine ratio

measurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* diabetes

Exclusion criteria

* microscopic hematuria * pyuria * urinary cast

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Sensitivity and Specificity	through study completion, an average of 18 months	Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026