Screening for oligoalbuminuria by means of Micral-Test II. A new immunological test strip

Abstract

A new dip-and-read test strip for systematic detection of oligoalbuminuria was assessed. The test is based on a competition for gold-labelled anti-albumin antibodies between specimen albumin and albumin molecules immobilised in the test strip. The final detection area is coloured by excess free antibodies. The colour reaction is compared to a colour scale reflecting 0, 20, 50 and 100 mg/l albumin. Method comparison with an immuno-turbidimetric quantitative technique was performed on 747 unselected specimens. The correlation coefficient was 0.938, the Spearman rank coefficient 0.863. In spite of considerable overlap of the results attributed to the 4 colour blocks, the test was found to be perfectly useful as a 2-class-test, as there were practically no false negative tests and as all the specimens yielding reactions stronger than the 20 mg/l colour block were found to contain 20 mg/l albumin or more by the reference method. The colour block 20 mg/l represents the inevitable grey zone, results in this range being found to be normal and increased above this pathological cut-off by the reference method. Follow-up by quantitative albumin dosage in timed morning urine for all specimens found positive by the dipstick confirms the existence of oligoalbuminuria, eliminating the cases of orthostatic albuminuria, of oligoalbuminuria simulated by low diuresis and the false positives due to oversensitivity of the test strip. The test strip is easy to handle. The reaction time is short and the colour reaction is stable and easy to read. Systematic use of this test in routine urine chemistry is suggested.