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<sup>®</sup> and the albumin-specific immuno...

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Main Authors: Nikolai C. Hodel, Ali Hamad, Klaus Reither, Irene Mndala Kasella, Salim Abdulla, Andreas Schoetzau, Christoph F. R. Hatz, Michael Mayr
Format: Article
Language:English
Published: MDPI AG 2021-01-01
Series:Diagnostics
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Online Access:https://www.mdpi.com/2075-4418/11/1/81
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author Nikolai C. Hodel
Ali Hamad
Klaus Reither
Irene Mndala Kasella
Salim Abdulla
Andreas Schoetzau
Christoph F. R. Hatz
Michael Mayr
author_facet Nikolai C. Hodel
Ali Hamad
Klaus Reither
Irene Mndala Kasella
Salim Abdulla
Andreas Schoetzau
Christoph F. R. Hatz
Michael Mayr
author_sort Nikolai C. Hodel
collection DOAJ
description 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<sup>®</sup> and the albumin-specific immunochromatographic assay Micral-Test<sup>®</sup> 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<sup>®</sup> and Micral-Test<sup>®</sup>, respectively. Correct classification to KDIGO albuminuria stages A2/A3 with the Combur9-Test<sup>®</sup> was 15.4%, 51.4%, and 87.9% at cut-offs of 30, 100, and ≥300 mg/dL, and with the Micral-Test<sup>®</sup> 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<sup>®</sup> and Micral-Test<sup>®</sup>, 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<sup>®</sup> and Micral-Test<sup>®</sup>, respectively. Conclusion: Compared to the Combur9-Test<sup>®</sup>, the utility of the Micral-Test<sup>®</sup> is limited, because the fraction of correctly ruled out patients is small and a large proportion with a positive Micral-Test<sup>®</sup> require a subsequent ACR conformation test.
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spelling doaj.art-342f6489848446fbadd13b5c5221947f2023-12-03T12:13:56ZengMDPI AGDiagnostics2075-44182021-01-011118110.3390/diagnostics11010081Comparison of Two Different Semiquantitative Urinary Dipstick Tests with Albumin-to-Creatinine Ratio for Screening and Classification of Albuminuria According to KDIGO. A Diagnostic Test StudyNikolai C. Hodel0Ali Hamad1Klaus Reither2Irene Mndala Kasella3Salim Abdulla4Andreas Schoetzau5Christoph F. R. Hatz6Michael Mayr7Medical Outpatient Department, University Hospital Basel, 4031 Basel, SwitzerlandChronic Disease Clinic, Ifakara Health Institute, Bagamoyo P.O. Box 74, TanzaniaClinical Research Unit, Swiss Tropical and Public Health Institute, 4051 Basel, SwitzerlandOutpatient Clinic, Bagamoyo District Hospital, Bagamoyo P.O. Box 29, TanzaniaChronic Disease Clinic, Ifakara Health Institute, Bagamoyo P.O. Box 74, TanzaniaFaculty of Science, University of Basel, 4001 Basel, SwitzerlandClinical Research Unit, Swiss Tropical and Public Health Institute, 4051 Basel, SwitzerlandMedical Outpatient Department, University Hospital Basel, 4031 Basel, SwitzerlandBackground: 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<sup>®</sup> and the albumin-specific immunochromatographic assay Micral-Test<sup>®</sup> 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<sup>®</sup> and Micral-Test<sup>®</sup>, respectively. Correct classification to KDIGO albuminuria stages A2/A3 with the Combur9-Test<sup>®</sup> was 15.4%, 51.4%, and 87.9% at cut-offs of 30, 100, and ≥300 mg/dL, and with the Micral-Test<sup>®</sup> 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<sup>®</sup> and Micral-Test<sup>®</sup>, 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<sup>®</sup> and Micral-Test<sup>®</sup>, respectively. Conclusion: Compared to the Combur9-Test<sup>®</sup>, the utility of the Micral-Test<sup>®</sup> is limited, because the fraction of correctly ruled out patients is small and a large proportion with a positive Micral-Test<sup>®</sup> require a subsequent ACR conformation test.https://www.mdpi.com/2075-4418/11/1/81albuminuriaurinary dipstick testalbumin-to-creatinine ratioACRdiagnostic test studyMicral-Test<sup>®</sup>
spellingShingle Nikolai C. Hodel
Ali Hamad
Klaus Reither
Irene Mndala Kasella
Salim Abdulla
Andreas Schoetzau
Christoph F. R. Hatz
Michael Mayr
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
Diagnostics
albuminuria
urinary dipstick test
albumin-to-creatinine ratio
ACR
diagnostic test study
Micral-Test<sup>®</sup>
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic albuminuria
urinary dipstick test
albumin-to-creatinine ratio
ACR
diagnostic test study
Micral-Test<sup>®</sup>
url https://www.mdpi.com/2075-4418/11/1/81
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