The persistent appearance of small amounts of albumin (microalbuminuria) in urine could be the first indicator of a renal dysfunction. For persons with diabetes, a positive result could be the first indicator of a diabetic nephropathy. Without initiation of therapy, the amount of released albumin will increase (macroalbuminuria) and a renal insufficiency will occur.

In case of type-2 diabetes, the early diagnosis and therapy of diabetic nephropathy is especially important. In addition to the renal dysfunction, cardiovascular risks could occur.

At normal physiological conditions, small amounts of albumin are glomerular filtrated and tubular reabsorbed. The expulsion of 20μg/mL to 200μg/mL is characterized as microalbuminuria. In

addition to renal dysfunctions, albuminuria can be caused by physical training, infections of the urinary tract, hypertension, cardiac insufficiency and surgery. If the amount of albumin decreases after disappearance of these factors, the transient albuminuria is without any pathological reason.

The accuracy of the Microalbumin test was evaluated in comparison to a commercially available immunoassay at a cut-off of 20μg/mL. 100 urine samples, collected from volunteers, have been tested by both procedures with >98% agreement.

The reproducibility of the Microalbumin test was evaluated at 4 different sites using blind controls. Of 50 samples with albumin concentrations <10μg/mL, all were determined negatives.

Of 50 samples with albumin concentrations >40μg/mL, all were determined positive.

The Microalbumin test has a sensitivity of 20μg/mL urine.

The specificity for the Microalbumin test was tested by adding various compounds that are likely to be present in urine. All compounds were prepared in normal human urine with low amounts of albumin.