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Clinical Chemistry 55: 1991-1994, 2009. First published September 10, 2009; 10.1373/clinchem.2009.129833
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(Clinical Chemistry. 2009;55:1991-1994.)
© 2009 American Association for Clinical Chemistry, Inc.


Proteomics and Protein Markers

Comparison of Urinary Albumin Quantification by Immunoturbidimetry, Competitive Immunoassay, and Protein-Cleavage Liquid Chromatography–Tandem Mass Spectrometry

Jesse C. Seegmiller1, Denis Sviridov3, Timothy S. Larson1,2, Timothy M. Borland1, Glen L. Hortin3,1 and John C. Lieske1,2,a

1 Department of Laboratory Medicine and Pathology, 2 Department of Internal Medicine, Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN; 3 NIH, Department of Laboratory Medicine, Bethesda, MD.

aAddress correspondence to this author at: Renal Function Laboratory, Mayo Clinic Department of Laboratory Medicine and Pathology, 200 First St SW, Rochester, MN 55905. E-mail Lieske.John{at}mayo.edu.

Background: Increased urinary albumin excretion is a well-documented diagnostic and prognostic biomarker for renal disease. Urinary albumin is typically measured in clinical settings by immunoassay methods. However, neither a reference method nor a urine albumin calibration reference material is currently available.

Methods: We quantified urinary albumin in patient samples by using 3 commercially available reagent systems: DiaSorin SPQTM and Beckman Coulter LX® 20 (immunoturbidimetric), and Siemens Immulite® (competitive immunoassay). Results were compared to values obtained by protein-cleavage liquid chromatography–tandem mass spectrometry (LC-MS/MS).

Results: In general, results from the 3 immunoassays agreed with results from LC-MS/MS. However, the SPQ results showed a negative bias across all ranges of albuminuria [(0–200 mg/L, y = 0.91x – 3.74 (CI 0.86–0.96); > 200 mg/L, y = 0.88x – 40.30 (CI 0.76–1.00)], whereas the LX 20 showed minimal bias in the 0–200 mg/L range [y = 0.97x – 88 (CI 0.92–1.02)] and the Immulite assay showed positive bias in the 0–200 mg/L range [y = 1.15x – 4.38 (CI 1.09–1.20)].

Conclusions: These results showed a reasonable quantification of urinary albumin by representative polyclonal and monoclonal immunoassays compared to an LC-MS/MS assay. In addition, the results do not suggest the presence of nonimmunoreactive albumin in urine. However, differences in analytic performance between assays support the need for a reference calibration material and reference method to standardize clinical laboratory measurements of urinary albumin.







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