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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

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
*
Author to whom correspondence should be addressed.
Diagnostics 2021, 11(1), 81; https://doi.org/10.3390/diagnostics11010081
Received: 5 November 2020 / Revised: 18 December 2020 / Accepted: 18 December 2020 / Published: 6 January 2021
(This article belongs to the Section Point-of-Care Diagnostics and Devices)
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. View Full-Text
Keywords: albuminuria; urinary dipstick test; albumin-to-creatinine ratio; ACR; diagnostic test study; Micral-Test®; Coumbur9-Test®; diagnostic evaluation; point-of-care diagnostics albuminuria; urinary dipstick test; albumin-to-creatinine ratio; ACR; diagnostic test study; Micral-Test®; Coumbur9-Test®; diagnostic evaluation; point-of-care diagnostics
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MDPI and ACS Style

Hodel, N.C.; Hamad, A.; Reither, K.; Kasella, I.M.; Abdulla, S.; Schoetzau, A.; Hatz, C.F.R.; Mayr, M. 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 2021, 11, 81. https://doi.org/10.3390/diagnostics11010081

AMA Style

Hodel NC, Hamad A, Reither K, Kasella IM, Abdulla S, Schoetzau A, Hatz CFR, Mayr M. 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. 2021; 11(1):81. https://doi.org/10.3390/diagnostics11010081

Chicago/Turabian Style

Hodel, Nikolai C., Ali Hamad, Klaus Reither, Irene M. Kasella, Salim Abdulla, Andreas Schoetzau, Christoph F.R. Hatz, and Michael Mayr. 2021. "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 11, no. 1: 81. https://doi.org/10.3390/diagnostics11010081

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