A solid phase enzyme immunoassay for the measurement of urinary albumin and the detection of microalbuminuria.

A test for the measurement of trace urinary albumin concentrations, which is suitable for the detection of microalbuminuria, was developed. The technique is an indirect enzyme-linked assay (ELISA) in which a fixed amount of anti-albumin antibody is placed into polystyrene tubes coated with human albumin, together with the urine sample to be tested. The albumin in the test specimen competes with the solid-phase albumin for binding to the added antibody. The test is precise (inter- and intra-assay coefficients of variation were 8.2% and 7.8%, respectively), accurate (mean recovery 102-106% for two human albumin preparations), and sensitive (detection limit 0.9 micrograms/ml). These characteristics are not dissimilar from those of the radioimmunoassay reported in the literature, with the advantages of being completely safe, easy to perform, and not requiring expensive equipment. Using this assay the urinary albumin excretion in 20 normal subjects was found to be 2.5 +/- 2.2 micrograms/min (range 0.9-7.5 micrograms/min) after 8 hours of bed rest and 4.5 +/- 5.7 micrograms/min (range 1.5-2.0 micrograms/min) after 8 hours of moderate physical activity.