BACKGROUND: Diabetic nephropathy (DN) affects up to 40% of diabetic patients and must be screened by the measurement of urinary albumin with a sensitive quantitative method. OBJECTIVE: To evaluate the impact of different immunoturbidimetric methods to measure albuminuria in the classification of DN stages. MATERIAL AND METHOD: Albumin was measured in 167 urine samples (65 24 h samples and 102 casual samples) by two immunoturbidimetric methods: Aptec BioSys, ADVIA® 1650 Bayer (AlbUAdvia) and Malb Urin-Pack Bayer®, CobasMira® Roche (AlbUCobas). AlbUCobas was definedas the comparative method used to classify the samples in: normoalbuminuric (albuminuria < 30 mg/24 h or <17 mg/l; n = 81), microalbuminuric (albuminuria 30-299 mg/24 hor 17-173 mg/l; n =55) and macroalbuminuric (albuminuria > 300 mg/24 h or > 174 mg/l; n = 31). The intra and interassay coefficients of variation (CVs), sensitivity and linearity of each method were calculated and the analytical and diagnostic agreements were analyzed by Deming's regression and Bland-Altman plots and by Kappa coefficient, respectively. RESULTS: The intra and interassay CVs were < 5% for both methods. The sensitivity was 5 mg/l for both methods and the linearity was 160 mg/l for AlbUCobas and 200 mg/l for AlbUAdvia. The analytical agreement between the two methods was satisfactory (mean differences between methods = -7.68 mg/l (-0.21 - 15.2); r = 0.989; p < 0.001) and the kappa coefficient (0,914; p < 0,001) was excellent. Only nine urine samples (5,4%) were in disagreement with AlbUCobas classification: six microalbuminuric samples were misclassified as normoalbuminuric (n = 3) and macroalbuminuric (n = 3) by AlbUAdvia. Three normoalbuminuric samples were misclassified as microalbuminuric by AlbUAdvia. The albumin values of these samples were in the highest diagnostic adopted cut-off point for each DN stage. CONCLUSION: The immunoturbidimetric methods analyzed may be interchangeable, without significant misclassification of the different stages of DN.
Diabetes mellitus; Diabetic nephropathy; Urinary albumin; Microalbuminuria; Methodology
