[Evaluation of novel test strip to measure albumin and creatinine in urine].

The purpose of this study was to evaluate the clinical usefulness of novel test strip that simultaneously measure urinary albumin and creatinine. Testing was performed on 95 random urine samples from diabetics. Each sample was assayed with following methods: test strip by instrument (AX4280) reading and by visual interpretation, quantitative method for albumin, creatinine, and alpha1-microglobulin and cellulose acetate membrane electrophoresis. The results of test strip had good correlation with quantitative results. In the case of instrument reading, the sensitivity, specificity and consistency were 91.2%, 78.9% and 86.3% for albumin and 94.5%, 87.5% and 91.6% for albumin index (albumin/creatinine ratio; A/C ratio), respectively. The percent same level agreement for creatinine was 63.2%. After correction using creatinine value on test strip, 18.4% of samples defined as negative by albumin quantitative value were turned to be positive, 12.3% of samples defined as positive were turned to be negative. The same level of creatinine correction effect as the quantitative method was obtained at the test strip. When alpha1-microglobulin/creatinine (alpha1 m/g x Cr) ratio was compared with albumin index, percent positive of alpha1 m/g x Cr ratio was 35.0% for samples with albumin index less than 30 mg/g x Cr, 59.5% for those with albumin index between 30 and 300 mg/g x Cr. In addition, on cellulose acetate membrane electrophoresis, both retinol binding protein (RBP) and beta2-microglobulin (beta2 m) were detected in 12.5% of patients in normal condition or pre-nephropathy. Among patients at early-nephropathy, the detection rate of RBP and beta2 m were 20.0% and 15.0% respectively. These results indicate that the renal tubule is also damaged at the early stages of nephropathy.