State of the art for measurement of urine albumin: comparison of routine measurement procedures to isotope dilution tandem mass spectrometry
Open accessAbstract
BACKGROUND: Urine albumin is the primary biomarker for detection and monitoring of kidney damage. Because fixed decision criteria are used to identify patients with increased values, we investigated if commonly used routine measurement procedures gave comparable results. METHODS: Results from 17 commercially available urine albumin measurement procedures were investigated vs an isotope dilution mass spectrometry (IDMS) procedure. Nonfrozen aliquots of freshly collected urine from 332 patients with chronic kidney disease, diabetes, cardiovascular disease, and hypertension were distributed to manufacturers to perform urine albumin measurements according to the respective instructions for use for each procedure. Frozen aliquots were used for measurements by the IDMS procedure. An error model was used to determine imprecision and bias components. RESULTS: Median differences between the largest positive and negative biases vs IDMS were 45%, 37%, and 42% in the concentration intervals of 12–30 mg/L, 31–200 mg/L, and 201–1064 mg/L, respectively. Biases varied with concentration for most procedures and exceeded ±10% over the concentration interval for 14 of 16 quantitative procedures. Mean biases ranged from −35% to 34% at 15 mg/L. Dilution of samples with high concentrations introduced bias for 4 procedures. The combined CV was >10% for 5 procedures. It was not possible to estimate total error due to dependence of bias on concentration. CVs for sample-specific influences were 0% to 15.2%. CONCLUSIONS: Bias was the dominant source of disagreement among routine measurement procedures. Consequently, standardization efforts will improve agreement among results. Variation of bias with concentration needs to be addressed by manufacturers.
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Mean biases of urine albumin measurement procedures were large and ranged from -35% to 34% at 15 mg/L.
“Mean biases were large and ranged from À35% to 34% at 15 mg/L.”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [498]
Calibration bias was the main source of error for differences among urine albumin measurement methods, and precision was adequate for most assays.
“The authors concluded that calibration bias was the main source of error for differences among methods and precision was adequate for most assays.”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [498]
Dipstick methods were compared with local laboratory methods, which exhibit large biases.
“An important limitation of all these data is that the dipstick methods were compared with local laboratory methods, which, as indicated above, exhibit large biases (498).”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [498]
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- Authors
- Bachmann, L. M., Nilsson, G., Bruns, D. E., McQueen, M. J., Lieske, J. C., Zakowski, J. J., & Miller, W. G.
- Affiliations
- Virginia Commonwealth University (US)
- Nilsson Measurement Quality, Uppsala, Sweden
- University of Virginia (US)
- McMaster University (CA)
- Mayo Clinic (US)
- Beckman Coulter (United States) (US)
- Corresponding author
- Bachmann, Lorin M
- Venue
- Clinical Chemistry
- Publisher
- Oxford University Press (OUP)
- Published
- 2014-03-01
- Volume
- 60
- Issue
- 3
- Pages
- 471-480
- ISSN
- 0009-9147 (ISSN-L)
- 1530-8561
- OpenAlex
- W2161581547
- Semantic Scholar
- 48f5d52a9321744beb1a9ca01615043e26a379e7
- Cited by
- 68
- References
- 16
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 4 · 2023: 7 · 2022: 4 · 2021: 3 · 2020: 5 · 2019: 6 · 2018: 5 · 2017: 10 · 2016: 5 · 2015: 7 · 2014: 6 · 2013: 1
- FWCI
- 4.36
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Clinical Chemistry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Pennsylvania (5-U01-DK-060990-10, 554511)
- National Institute of Diabetes and Digestive and Kidney Diseases
- NIH
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
- Keywords
- urinary albumin, albuminuria, isotope dilution mass spectrometry, measurement bias, imprecision, method comparison, chronic kidney disease, kidney injury biomarkers, measurement standardization, cardiovascular disease, hypertension, diabetes mellitus
- MeSH terms
- Adult, Aged, Aged, 80 and over, Humans, Indicator Dilution Techniques, Middle Aged, Oligopeptides, Serum Albumin, Urinalysis, Tandem Mass Spectrometry, Young Adult
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