Diabetes Care
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Diabetes Care, Vol 13, Issue 10 1069-1073, Copyright © 1990 by American Diabetes Association

ARTICLES

Evaluation of new rapid office test for microalbuminuria and its comparison to fully quantitative radioimmunoassay

RG Neuman, LV Bonomini and SN Braunstein
Exocell, Inc., Philadelphia, PA 19104.

A novel enzyme-linked immunosorbent assay (ELISA [Dialbumin]) for rapid office measurement of microalbuminuria was evaluated and its performance compared with that of a commercially available radioimmunoassay (double-antibody albumin). Urine samples containing between 0.75 and 1800 micrograms/ml of albumin were obtained from 31 diabetic patients and assayed by both methods. A comparison of the paired values obtained from the two methods gave a correlation coefficient of greater than 0.99. The Dialbumin assay, which used detachable eight-well strips (1 strip/sample), 10-min incubation, tap water wash, and a 2-min color development step, was read on both an ELISA reader and a hand-held analytical device (Acc-U-Dial) designed specifically for this test. The findings of this study indicate that the Dialbumin assay, used in conjunction with the Acc-U-Dial device, affords a rapid, convenient, and sensitive method for quantitative determination of a broad range (0.3-1280 micrograms/ml) of urinary albumin levels in the office setting.
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Diabetes Diabetes Care Clinical Diabetes Diabetes Spectrum
Copyright © 1990 by the American Diabetes Association.