Development of enzyme-linked immunosorbent assay for estimation of urinary albumin

J Immunoassay Immunochem. 2014;35(3):300-13. doi: 10.1080/15321819.2013.849729.

Abstract

Yearly estimation of urinary albumin is a prerequisite for predicting renal status in Diabetes Type II patients with negative dipstick results for overt proteinuria. A simple, sensitive, and cost-effective enzyme linked immunosorbent assay (ELISA) for urinary albumin has been developed using human serum albumin antiserum (HSA-antiserum), HSA-biotin, and streptavidin-horseradish peroxidase (SA-HRP) conjugates. To the antibody-coated wells, 100 μL of HSA standards followed by 1:100 diluted urine samples in duplicate were added and then 50 μL of HSA-biotin conjugates was added in all the wells. 100 μL of SA-HRP was added after washing. Bound enzyme activity was measured by adding 100 μL TMB/H2O2. The analytical sensitivity and ED50 of the developed method was found to be 0.01 μg/mL and 0.35 μg/mL, respectively. The percent recovery of the HSA from exogenously spiked urine pools were in the range of 98.13-100.29%. The intra- and inter-assay coefficient of variation (CVs) ranged from 3.38-10.32 % and 4.22-11.01%, respectively. The antibody showed 4.4% and 3.2% cross reactivity with monkey and horse serum albumin, respectively. There was no cross reaction with human β2-microglobulin, γ-globulin, and haemoglobulin.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Albuminuria / complications
  • Albuminuria / diagnosis*
  • Albuminuria / physiopathology
  • Animals
  • Biotin / chemistry
  • Case-Control Studies
  • Cross Reactions
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / diagnosis*
  • Diabetes Mellitus, Type 2 / physiopathology
  • Diabetes Mellitus, Type 2 / urine
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Female
  • Haplorhini
  • Horseradish Peroxidase / chemistry
  • Horses
  • Humans
  • Hydrogen Peroxide / chemistry
  • Immune Sera / chemistry
  • Immunoconjugates / chemistry
  • Kidney / metabolism
  • Kidney / physiopathology
  • Male
  • Middle Aged
  • Sensitivity and Specificity
  • Serum Albumin / chemistry
  • Serum Albumin / immunology
  • Streptavidin / chemistry

Substances

  • Immune Sera
  • Immunoconjugates
  • Serum Albumin
  • Biotin
  • Streptavidin
  • Hydrogen Peroxide
  • Horseradish Peroxidase