Measurement of urine albumin by liquid chromatography-isotope dilution tandem mass spectrometry and its application to value assignment of external quality assessment samples and certification of reference materials
Author:
Chen Yizhao1, Liu Hong1, Loh Tze Ping2, Liu Qinde1, Teo Tang Lin1, Lee Tong Kooi1, Sethi Sunil Kumar2
Affiliation:
1. Chemical Metrology Division, Applied Sciences Group , Health Sciences Authority , Singapore , Singapore 2. Department of Laboratory Medicine , National University Hospital , Singapore , Singapore
Abstract
Abstract
Objectives
Urine albumin is measured in clinical laboratories by immunoturbidimetry. However, large biases are observed among the different routine methods. To standardize the measurement of urine albumin, a reference measurement procedure (RMP) and urine albumin certified reference materials (CRMs) are needed.
Methods
A candidate RMP for urine albumin based on liquid chromatography-isotope dilution tandem mass spectrometry (LC-IDMS/MS) using human serum albumin as calibration standard was developed. Isotope-labeled human albumin was used as internal standard. Urine samples were digested using trypsin and eight resulting “signature” peptides of albumin were quantified by LC-IDMS/MS. The candidate RMP was employed in value assignment of external quality assessment (EQA) samples and certification of urine albumin reference materials. The commutability of the developed CRMs was assessed against patient samples.
Results
The candidate RMP (recovery 101.5–103.2% and CV 1.2–3.3% at about 7–40 mg/L) met optimal performance goal. The lower limit of quantification was 0.03 mg/L as determined by signal-to-noise method. The EQA results from clinical laboratories using different immunoturbidimetric methods were generally comparable with assigned target values determined by the candidate RMP, with albumin concentrations ranging from 5 to 226 mg/L. Urine albumin reference materials (two levels) certified using the candidate RMP showed good commutability in a preliminary study.
Conclusions
With optimal method precision and trueness, as well as comparability with routine methods, the developed RMP may be used for value assignment of EQA samples or certification of reference materials, which are important pillars in urine albumin method standardization.
Publisher
Walter de Gruyter GmbH
Subject
Biochemistry (medical),Clinical Biochemistry,General Medicine
Reference29 articles.
1. Yuyun, MF, Khaw, KT, Luben, R, Welch, A, Bingham, S, Day, NE, et al.. Microalbuminuria independently predicts all-cause and cardiovascular mortality in a British population: the European prospective investigation into cancer in Norfolk (EPIC-Norfolk) population study. Int J Epidemiol 2004;33:189–98, https://doi.org/10.1093/ije/dyh008. 2. Samak, MJ, Levey, AS, Schoolwerth, AC, Coresh, J, Culleton, B, Hamm, LL, et al.. Kidney disease as a risk factor for development of cardiovascular disease: a statement from American Heart Association Councils on kidney in cardiovascular disease, high blood pressure research, clinical cardiology, and epidemiology and prevention. Hypertension 2003;42:1050–65. https://doi.org/10.1161/01.CIR.0000095676.90936.80. 3. Hillege, HL, Fidler, V, Diercks, GF, van Gilst, WH, de Zeeuw, D, van Veldhuisen, DJ, et al.. Urinary albumin excretion predicts cardiovascular and noncardiovascular mortality in general population. Circulation 2002;106:1777–82, https://doi.org/10.1161/01.cir.0000031732.78052.81. 4. Mann, JF, Yi, QL, Gerstein, HC. Albuminuria as a predictor of cardiovascular and renal outcomes in people with known atherosclerotic cardiovascular disease. Kidney Int Suppl 2004;92:S59–62, https://doi.org/10.1111/j.1523-1755.2004.09215.x. 5. Eknoyan, G, Hostetter, T, Bakris, GL, Hebert, L, Levey, AS, Parving, HH, et al.. Proteinuria and other markers of chronic kidney disease: a position statement of the national kidney foundation (NKF) and the national institute of diabetes and digestive and kidney diseases (NIDDK). Am J Kidney Dis 2003;42:617–22, https://doi.org/10.1016/s0272-6386(03)00826-6.
Cited by
10 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
|
|