Microalbuminuria is a marker for the onset of incipient nephropathy, a condition that affects 35% of Type I diabetics. Incipient nephropathy develops over a period of years into end stage renal disease. The cost of care for diabetic patients with end stage renal disease is about $750 million per year. Early glycemic regulation and therapeutic intervention can slow or halt the progress of incipient nephropathy toward end stage renal disease. The objective is to develop a semiquantitative immunoassay for low levels of albumin in urine. The assay can be performed in doctors' offices and by patients at home. The assay is based on immunochromatography with urine as the developing liquid. A competitive binding immunoassay format will be evaluated. Antibody to human albumin will be immobilized on a microporous membrane such as nitrocellulose and this will be the chromatography support medium. A colored latex label will be coated with human albumin and will be dried near the bottom of the chromatography strip. The urine sample will contact the colored latex first and it will migrate with the urine onto the strip. Immunobinding will capture the colored latex on the strip and create a colored band. The position of the colored band will be read visually and related to the albumin concentration.
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