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Updated: Mar 21, 2026

Assessment of Kidney Function in Mouse Models of Glomerular Disease
Published on: June 30, 2018
Measuring urine albumin and total protein.
W Greg Miller1, Jesse C Seegmiller2, Lorin M Bachmann1
1Department of Pathology, Virginia Commonwealth University, Richmond, VA, USA.
Standardizing urine albumin (UA) measurements is nearing completion with new reference materials. However, standardizing urine total protein (UTP) measurements remains challenging due to diverse analytical methods used in in-vitro diagnostic medical devices.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Biomarker Standardization
Background:
- Urine albumin (UA) and total protein (UTP) are vital biomarkers for assessing kidney disease.
- Current clinical guidelines rely on fixed thresholds for UA and UTP, but results vary significantly across different in-vitro diagnostic medical devices (IVD-MDs).
- Previous studies show substantial discrepancies (37-45% for UA, ~50% for UTP) in measurements from various IVD-MDs, potentially leading to misdiagnosis and incorrect medical decisions.
Purpose of the Study:
- To address the lack of standardization in UA and UTP measurements from IVD-MDs.
- To highlight the development of higher-order reference materials and procedures for UA standardization.
- To explain the challenges and lack of current plans for UTP standardization.
Main Methods:
- Development of higher-order certified reference materials (CRMs) and reference measurement procedures (RMPs) for UA.
- Utilizing external quality assurance programs to assess UTP measurement variability.
- Analysis of calibration schemes and analytical methods employed by IVD-MDs for UA and UTP.
Main Results:
- A standardization program has successfully developed higher-order CRMs and RMPs for UA, paving the way for standardized measurements.
- Transition to the new UA reference system by IVD-MD manufacturers is anticipated to improve result agreement.
- Significant inter-device variability persists for UTP, with no clear path toward standardization due to diverse chemical reactions and disease-dependent protein variations.
Conclusions:
- Standardization of UA measurements is achievable and expected soon through the implementation of new reference materials and procedures.
- Standardization of UTP measurements faces significant technical hurdles, making current efforts to improve inter-device agreement unlikely.
- The lack of standardized UTP measurements poses a continued risk for accurate kidney disease assessment and patient management.
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