Micral-Test: a qualitative dipstick test for micro-albuminuria.
Micro-albuminuria is a very sensitive predictor of the development of renal disease in insulin- and non-insulin-dependent diabetes mellitus. A reliable dipstick test for routine screening for micro-albuminuria is, therefore, desirable. Such a test has been developed by Boehringer Mannheim, Germany, and marketed as Micral-Test. It is an immunological slide-test with semi-quantitative properties. To evaluate its performance as a screening test we compared it with a turbidimetric immuno-assay. In 396 urine specimens from 132 patients, sensitivity was 91% and specificity 96% for a discriminating albumin level of 20 mg/l. Correlation with quantitative values was reasonable (r = 0.73). We also tested for micro-albuminuria, defined as mean albumin excretion rate of > or = 20 micrograms/min, determined with the turbidimetric immuno-assay in timed overnight urines on three consecutive days, whereas Micral-Test was considered to be positive for micro-albuminuria if the albumin concentration in one of the three urine samples was > or = 20 mg/ml. In 132 patients, the sensitivity of Micral-Test was 82% and the specificity 86%. Albumin excretion rate in all false-negative results was < 50 micrograms/min. We therefore concluded that Micral-Test is a useful qualitative screening test for micro-albuminuria in diabetic patients.
Spooren
P F
PF
Department of Internal Medicine and Clinical Chemistry, Medisch Spectrum Twente, Enschede, Netherlands.
Lekkerkerker
J F
JF
Vermes
I
I
D000419:Albuminuria; D003922:Diabetes Mellitus, Type 1 / Q000652:urine; D003924:Diabetes Mellitus, Type 2 / Q000652:urine; D003928:Diabetic Nephropathies / Q000175:diagnosis* / Q000652:urine; D006801:Humans; D007118:Immunoassay; D009391:Nephelometry and Turbidimetry; D011934:Reagent Strips; D012044:Regression Analysis
D011934:Reagent Strips