Startseite 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
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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

  • Yizhao Chen , Hong Liu , Tze Ping Loh , Qinde Liu EMAIL logo , Tang Lin Teo , Tong Kooi Lee und Sunil Kumar Sethi
Veröffentlicht/Copyright: 20. Oktober 2020
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 59 Heft 4

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.

Keywords: commutability; external quality assessment; isotope dilution mass spectrometry; reference materials; reference measurement procedure; urine albumin
Corresponding author: Qinde Liu, Chemical Metrology Division, Applied Sciences Group, Health Sciences Authority, 1 Science Park Road, #01-05/06, The Capricorn, Singapore Science Park II, Singapore 117528, Singapore, Phone +65 6775 1605 ext 102, Fax: +65 6775 1398, E-mail:

Acknowledgments

The authors are grateful to the Health Sciences Authority, Singapore for the support of this project.

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The use of leftover patient urine samples in this study has been approved by the National Healthcare Group Domain Specific Review Board (Reference No. DSRB 2016/01201) and complied with the Declaration of Helsinki.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-0969).

Received: 2020-06-23
Accepted: 2020-09-27
Published Online: 2020-10-20
Published in Print: 2021-03-26

© 2020 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2020-0969
Schlagwörter für diesen Artikel
commutability; external quality assessment; isotope dilution mass spectrometry; reference materials; reference measurement procedure; urine albumin

Artikel in diesem Heft

  1. Frontmatter
  2. Editorials
  3. Perspectives in developments of mass spectrometry for improving diagnosis and monitoring of multiple myeloma and other plasma cell disorders
  4. Cytokine “storm”, cytokine “breeze”, or both in COVID-19?
  5. Review
  6. Clinical relevance of biological variation of cardiac troponins
  7. General Clinical Chemistry and Laboratory Medicine
  8. Development of novel methods for non-canonical myeloma protein analysis with an innovative adaptation of immunofixation electrophoresis, native top-down mass spectrometry, and middle-down de novo sequencing
  9. Falsely markedly elevated 25-hydroxyvitamin D in patients with monoclonal gammopathies
  10. Development of a pregnancy-specific reference material for thyroid biomarkers, vitamin D, and nutritional trace elements in serum
  11. Applying the concept of uncertainty to the sFlt-1/PlGF cut-offs for diagnosis and prognosis of preeclampsia
  12. Reducing sample rejection in Durban, South Africa
  13. Quality benchmarking of smartphone laboratory medicine applications: comparison of laboratory medicine specialists’ and non-laboratory medicine professionals’ evaluation
  14. Urine soluble CD163 (sCD163) as biomarker in glomerulonephritis: stability, reference interval and diagnostic performance
  15. 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
  16. Choice of faecal immunochemical test matters: comparison of OC-Sensor and HM-JACKarc, in the assessment of patients at high risk of colorectal cancer
  17. Reference Values and Biological Variations
  18. Reference values of trace elements in blood and/or plasma in adults living in Belgium
  19. Cancer Diagnostics
  20. Clinical performance of calcitonin and procalcitonin Elecsys® immunoassays in patients with medullary thyroid carcinoma
  21. Cardiovascular Diseases
  22. Analytical assessment of ortho clinical diagnostics high-sensitivity cardiac troponin I assay
  23. Evaluation of the 0 h/1 h high-sensitivity cardiac troponin T algorithm in diagnosis of non-ST-segment elevation myocardial infarction (NSTEMI) in Han population
  24. Diabetes
  25. Are hemoglobin A1c point-of-care analyzers fit for purpose? The story continues
  26. Infectious Diseases
  27. Diagnostic and prognostic role of presepsin in patients with cirrhosis and bacterial infection
  28. Hemocytometric characteristics of COVID-19 patients with and without cytokine storm syndrome on the sysmex XN-10 hematology analyzer
  29. Letters to the Editor
  30. Letter in reply to the letter to the editor of Geerts N and Schanhorst V with the title “Roche Troponin T hs-STAT meets all expert opinion analytical laboratory practice recommendations for the use of the differential diagnosis of acute coronary syndrome”
  31. Improving measurement uncertainty of plasma electrolytes: a complex but not impossible task
  32. Truncation limits of patient-based real-time quality control: a new model derived from between-subject biological variations
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  34. Exogenous triglycerides interfere with a point of care CRP assay: a pre-analytical caveat
  35. Monoclonal components in alpha-2 region should not be neglected in capillary electrophoresis
  36. Do not measure an extra high value monoclonal IgM by immunoturbidity: a case report
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  38. Diagnosis of vitamin B12 deficiency: combined indicator of B12-status should be interpreted with caution in the case of renal impairment
  39. Could the UKNEQAS program “Manual Differential Blood Count” be performed by the use of an automated digital morphology analyzer (Sysmex DI-60)? A feasibility study
  40. Low-dose oral methotrexate-induced crystalluria
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