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Updated: Dec 11, 2025
Assessment of Kidney Function in Mouse Models of Glomerular Disease
Published on: June 30, 2018
An enzyme immunoassay for determining albumin in human urine samples using an ultra-microanalytical system
Ruben Del Valle1, Juliette M Cazanave Mora2, Nancy L Carrazana San Martín2
1Research Laboratory, Immunoassay Center , Havana, Cuba.
Abstract:
Microalbuminuria is a term to describe a moderate increase in the level of albumin in urine. It is an important prognostic marker for kidney damage in diseases such as diabetes mellitus and hypertension. A simple sandwich-type ultramicroELISA assay (UMELISA) has been developed for the measurement of albumin in human urine samples. Strips coated with a high affinity monoclonal antibody directed against albumin are used as solid phase, to ensure the specificity of the assay. The albumin assay was completed in 1 hr and 30 min, with a measuring range of 1.44-200 ng/mL. The intra- and inter-assay coefficients of variation were 3.98-4.35% and 7.59-8.92%, respectively, depending on the albumin concentrations evaluated. Percentage recovery ranged from 94.26 to 98.50%. Regression analysis showed a good correlation with the commercial quantitative turbidimetric test Microalbumin-turbilatex (n = 240, r = 0.994, p < .01). The analytical performance characteristics of our UMELISA MICROALBUMINA endorse its use for the quantification of albumin in human urine samples. This test will make a cost-effective diagnostic kit accessible to low-income countries such as Latin American countries and is now available in the Cuban Public Health System.
Insights
A new ultramicroELISA assay (UMELISA) accurately measures microalbuminuria, a key indicator of kidney damage. This cost-effective test enhances early detection of kidney disease in populations worldwide.
Area of Science:
- Clinical Chemistry
- Immunology
- Nephrology
Background:
- Microalbuminuria indicates moderate albumin increase in urine, signaling kidney damage.
- Diabetes mellitus and hypertension are primary conditions linked to microalbuminuria.
- Accurate measurement of urinary albumin is crucial for prognostic assessment.
Purpose of the Study:
- To develop and validate a novel sandwich-type ultramicroELISA (UMELISA) assay for human urine albumin quantification.
- To assess the analytical performance and diagnostic utility of the developed UMELISA assay.
- To provide a cost-effective diagnostic tool for microalbuminuria detection.
Main Methods:
- Development of a sandwich-type ultramicroELISA (UMELISA) using monoclonal antibody-coated strips.
- Assay validation including measurement range, assay completion time, and coefficient of variation.
- Comparison of UMELISA results with a commercial quantitative turbidimetric assay (Microalbumin-turbilatex).
Main Results:
- The UMELISA assay provided results within 1 hour and 30 minutes.
- The measuring range was 1.44-200 ng/mL with low intra- (3.98-4.35%) and inter-assay (7.59-8.92%) variability.
- Excellent correlation (r=0.994, p<.01) was observed between UMELISA and the commercial assay.
Conclusions:
- The UMELISA MICROALBUMINA assay demonstrates robust analytical performance for urine albumin quantification.
- This assay is a specific, sensitive, and cost-effective method for detecting microalbuminuria.
- The test is suitable for widespread use, particularly in resource-limited settings like Latin America.
