Evaluation of new rapid office test for microalbuminuria and its comparison to fully quantitative radioimmunoassay.
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.
Neuman
R G
RG
Exocell, Inc., Philadelphia, PA 19104.
Bonomini
L V
LV
Braunstein
S N
SN
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000419:Albuminuria / Q000175:diagnosis* / Q000652:urine; D002498:Centrifugation; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation / Q000592:standards; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D011863:Radioimmunoassay / Q000379:methods / Q000592:standards; D011934:Reagent Strips / Q000592:standards; D012494:Sampling Studies; D013997:Time Factors
D011934:Reagent Strips