Nikolai C Hodel1,2, Ali Hamad3, Klaus Reither2,3,4, Irene Mndala Kasella5, Salim Abdulla3, Andreas Schoetzau4, Christoph F R Hatz2,4,6, Michael Mayr1. 1. Medical Outpatient Department, University Hospital Basel, 4031 Basel, Switzerland. 2. Clinical Research Unit, Swiss Tropical and Public Health Institute, 4051 Basel, Switzerland. 3. Chronic Disease Clinic, Ifakara Health Institute, Bagamoyo P.O. Box 74, Tanzania. 4. Faculty of Science, University of Basel, 4001 Basel, Switzerland. 5. Outpatient Clinic, Bagamoyo District Hospital, Bagamoyo P.O. Box 29, Tanzania. 6. Infectiology/Hospital Hygiene Department, Cantonal Hospital, 9007 St. Gallen, Switzerland.
Abstract
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® and the albumin-specific immunochromatographic assay Micral-Test® 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® and Micral-Test®, respectively. Correct classification to KDIGO albuminuria stages A2/A3 with the Combur9-Test® was 15.4%, 51.4%, and 87.9% at cut-offs of 30, 100, and ≥300 mg/dL, and with the Micral-Test® 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® and Micral-Test®, 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® and Micral-Test®, respectively. CONCLUSION: Compared to the Combur9-Test®, the utility of the Micral-Test® is limited, because the fraction of correctly ruled out patients is small and a large proportion with a positive Micral-Test® require a subsequent ACR conformation test.
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® and the albumin-specific immunochromatographic assay Micral-Test® 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® and Micral-Test®, respectively. Correct classification to KDIGO albuminuria stages A2/A3 with the Combur9-Test® was 15.4%, 51.4%, and 87.9% at cut-offs of 30, 100, and ≥300 mg/dL, and with the Micral-Test® 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® and Micral-Test®, 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® and Micral-Test®, respectively. CONCLUSION: Compared to the Combur9-Test®, the utility of the Micral-Test® is limited, because the fraction of correctly ruled out patients is small and a large proportion with a positive Micral-Test® require a subsequent ACR conformation test.
Entities:
Keywords:
ACR; Coumbur9-Test®; Micral-Test®; albumin-to-creatinine ratio; albuminuria; diagnostic evaluation; diagnostic test study; point-of-care diagnostics; urinary dipstick test
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