Micral-test strips evaluated for screening for albuminuria.

We have evaluated Micral-Test, an immunochemical strip test specific for albumin, as a screening tool for slight ("micro") albuminuria. First morning urine samples containing albumin concentrations (by radioimmunoassay) of 0.4-440 mg/L were collected from 112 diabetic patients. The Micral-Test result for each sample was assessed by one observer. All 34 samples having albumin concentrations greater than or equal to 20 mg/L and 71 of 78 samples less than 20 mg/L were correctly identified, giving 100% sensitivity and 91% specificity. Six samples were measured 10 times by one observer: three samples were read consistently; one, albumin concentration 86 mg/L, was read as 50 and 100 mg/L; and two, albumin concentrations 32 and 38 mg/L, were read as 20 and 50 mg/L, respectively. Contact with urine for 2 s rather than the recommended 5 s resulted in an underestimation of the albumin concentration in 13 of 35 samples (Z = -3.18, P = 0.001), as did taking readings earlier than the recommended 5 min (Z = -3.92, P less than 0.001). Six observers independently performed Micral-Test measurements on 10 samples. Eight samples were correctly classified as greater than or equal to 20 or less than 20 mg/L by all observers, but two (albumin concentrations 25 and 18 mg/L) were misclassified by at least one observer. The Micral-Test is a sensitive and specific screening tool, but is semiquantitative and critically time dependent.