Comparison of two different semiquantitative urinary dipstick tests with albumin-to-creatinine ratio for screening and classification of albuminuria according to KDIGO. A diagnostic test study

BACKGROUND: Semiquantitative dipstick tests are utilized for albuminuria screening. METHODS: In a prospective cross-sectional survey, we analyzed the diagnostic test validity of the semiquantitative colorimetric indicator-dye-based Combur9-Test((R)) and the albumin-specific immunochromatographic assay Micral-Test((R)) for the detection of albuminuria, the distribution of the semiquantitative measurements within the albuminuria stages according to KDIGO, and the utility for albuminuria screening compared with an albumin-to-creatinine ratio (ACR) in a walk-in population. RESULTS: In 970 subjects, albuminuria (>/=30 mg/g) was detected in 12.7% (95% CI 85.6-96.3%) with the ACR. Sensitivity was 82.9% (95% CI 75.1-89.1%) and 91.9% (95% CI 88.7-96.9%) and specificity 71.5% (95% CI 68.4-74.6%) and 17.5% (95% CI 15.0-20.2%) for the Combur9-Test((R)) and Micral-Test((R)), respectively. Correct classification to KDIGO albuminuria stages A2/A3 with the Combur9-Test((R)) was 15.4%, 51.4%, and 87.9% at cut-offs of 30, 100, and >/=300 mg/dL, and with the Micral-Test((R)) it was 1.8%, 10.5%, and 53.6% at cut-offs of 2, 5, and 10 mg/dL, respectively. Overall, disagreement to KDIGO albuminuria was seen in 27% and 73% with the Combur9-Test((R)) and Micral-Test((R)), respectively. From the total population, 62.5% and 15.3% were correctly ruled out and 2.2% and 1% were missed as false-negatives by the Combur9-Test((R)) and Micral-Test((R)), respectively. CONCLUSION: Compared to the Combur9-Test((R)), the utility of the Micral-Test((R)) is limited, because the fraction of correctly ruled out patients is small and a large proportion with a positive Micral-Test((R)) require a subsequent ACR conformation test.