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Micral-test strips evaluated for screening for albuminuria
S M Marshall1, P A Shearing, K G Alberti
1Department of Medicine, Medical School, Newcastle upon Tyne, U.K.
Clinical Chemistry
|April 1, 1992
Summary
The Micral-Test effectively screens for microalbuminuria in diabetic patients, showing high sensitivity and specificity. However, results can be affected by timing and observer variability, making it semiquantitative.
Area of Science:
- Clinical Chemistry
- Nephrology
- Diabetology
Background:
- Diabetic nephropathy is a major complication of diabetes.
- Early detection of microalbuminuria is crucial for managing diabetic nephropathy.
- Screening tools for microalbuminuria are needed for routine clinical practice.
Purpose of the Study:
- To evaluate the Micral-Test, an immunochemical strip test, as a screening tool for microalbuminuria.
- To determine the sensitivity and specificity of the Micral-Test in diabetic patients.
Main Methods:
- 112 diabetic patients provided first morning urine samples.
- Albumin concentrations were measured by radioimmunoassay and compared with Micral-Test results.
- Inter-observer and intra-observer variability were assessed.
- Impact of variations in urine contact time and reading time was evaluated.
Main Results:
- The Micral-Test demonstrated 100% sensitivity and 91% specificity for detecting albumin concentrations >= 20 mg/L.
- Consistent results were observed for some samples, while others showed variability.
- Underestimation of albumin occurred with shorter urine contact times and earlier readings.
- Some misclassifications were noted among different observers.
Conclusions:
- The Micral-Test is a sensitive and specific tool for screening microalbuminuria in diabetic patients.
- The test's semiquantitative nature and dependence on precise timing and consistent observation are limitations.
- Careful adherence to testing protocols is essential for accurate results.