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Performance of electrolyte measurements assessed by a trueness verification program

  • Menglei Ge , Haijian Zhao , Ying Yan , Tianjiao Zhang , Jie Zeng , Weiyan Zhou , Yufei Wang , Qinghui Meng and Chuanbao Zhang EMAIL logo
Published/Copyright: March 24, 2016
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 8

Abstract

Background: In this study, we analyzed frozen sera with known commutabilities for standardization of serum electrolyte measurements in China.

Methods: Fresh frozen sera were sent to 187 clinical laboratories in China for measurement of four electrolytes (sodium, potassium, calcium, and magnesium). Target values were assigned by two reference laboratories. Precision (CV), trueness (bias), and accuracy [total error (TEa)] were used to evaluate measurement performance, and the tolerance limit derived from the biological variation was used as the evaluation criterion.

Results: About half of the laboratories used a homogeneous system (same manufacturer for instrument, reagent and calibrator) for calcium and magnesium measurement, and more than 80% of laboratories used a homogeneous system for sodium and potassium measurement. More laboratories met the tolerance limit of imprecision (coefficient of variation [CVa]) than the tolerance limits of trueness (biasa) and TEa. For sodium, calcium, and magnesium, the minimal performance criterion derived from biological variation was used, and the pass rates for total error were approximately equal to the bias (<50%). For potassium, the pass rates for CV and TE were more than 90%. Compared with the non homogeneous system, the homogeneous system was superior for all three quality specifications.

Conclusions: The use of commutable proficiency testing/external quality assessment (PT/EQA) samples with values assigned by reference methods can monitor performance and provide reliable data for improving the performance of laboratory electrolyte measurement. The homogeneous systems were superior to the non homogeneous systems, whereas accuracy of assigned values of calibrators and assay stability remained challenges.

Keywords: bias; coefficient of variation; electrolyte; heterogeneous system; homogeneous system; total error
Corresponding author: Chuanbao Zhang, Beijing Hospital and National Center for Clinical Laboratories, No. 1 Dahua Road, Dongcheng District, Beijing 100730, P.R. China, Phone: +86 1058115059, Fax: +86 1065132968, E-mail:

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

  2. Research funding: This study was supported by research grants from the National High Technology Research and Development Program of China (863 Program) (No. 2011AA02A102 and No. 2011AA02A116).

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2015-11-12
Accepted: 2016-2-10
Published Online: 2016-3-24
Published in Print: 2016-8-1

©2016 by De Gruyter

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Laboratory analytical quality – the process continues
  4. Measurement uncertainty – a revised understanding of its calculation and use
  5. Review
  6. Substrate-zymography: a still worthwhile method for gelatinases analysis in biological samples
  7. Opinion Papers
  8. Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry
  9. The problem with total error models in establishing performance specifications and a simple remedy
  10. Measurement uncertainty for clinical laboratories – a revision of the concept
  11. Uncertainty in measurement and total error – are they so incompatible?
  12. General Clinical Chemistry and Laboratory Medicine
  13. Using the hazard ratio to evaluate allowable total error in predictive measurands
  14. Performance of electrolyte measurements assessed by a trueness verification program
  15. Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
  16. Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
  17. Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
  18. Patient-performed extraction of faecal calprotectin
  19. Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
  20. Reference Values and Biological Variations
  21. Sex-related differences in the association of ghrelin levels with obesity in adolescents
  22. Gestation specific reference intervals for thyroid function tests in pregnancy
  23. Cancer Diagnostics
  24. SOX17 promoter methylation in plasma circulating tumor DNA of patients with non-small cell lung cancer
  25. Dopamine concentration in blood platelets is elevated in patients with head and neck paragangliomas
  26. Letters to the Editor
  27. Cancer dynamics and the success of cancer screening programs
  28. Mother’s instinct – a rare case of multiple test interferences due to heterophile antibodies
  29. Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs
  30. A national survey of preanalytical handling of oral glucose tolerance tests in pregnancy
  31. Updating pregnancy diabetes guidelines: is (y)our laboratory ready?
  32. Low serum bilirubin values are associated with pulmonary embolism in a case-control study
  33. Effect of Hb H on HbA1c measurements as measured by IFCC reference method and affinity HPLC
  34. Adipocytes in venipunctures cause falsely elevated S-100B serum values
  35. Earlier detection of sepsis by Candida parapsilosis using three-dimensional cytographic anomalies on the Mindray BC-6800 hematological analyzer
  36. Theranos phenomenon – part 4: Theranos at an International Conference
https://doi.org/10.1515/cclm-2015-1110
Keywords for this article
bias; coefficient of variation; electrolyte; heterogeneous system; homogeneous system; total error

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Laboratory analytical quality – the process continues
  4. Measurement uncertainty – a revised understanding of its calculation and use
  5. Review
  6. Substrate-zymography: a still worthwhile method for gelatinases analysis in biological samples
  7. Opinion Papers
  8. Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry
  9. The problem with total error models in establishing performance specifications and a simple remedy
  10. Measurement uncertainty for clinical laboratories – a revision of the concept
  11. Uncertainty in measurement and total error – are they so incompatible?
  12. General Clinical Chemistry and Laboratory Medicine
  13. Using the hazard ratio to evaluate allowable total error in predictive measurands
  14. Performance of electrolyte measurements assessed by a trueness verification program
  15. Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
  16. Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
  17. Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
  18. Patient-performed extraction of faecal calprotectin
  19. Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
  20. Reference Values and Biological Variations
  21. Sex-related differences in the association of ghrelin levels with obesity in adolescents
  22. Gestation specific reference intervals for thyroid function tests in pregnancy
  23. Cancer Diagnostics
  24. SOX17 promoter methylation in plasma circulating tumor DNA of patients with non-small cell lung cancer
  25. Dopamine concentration in blood platelets is elevated in patients with head and neck paragangliomas
  26. Letters to the Editor
  27. Cancer dynamics and the success of cancer screening programs
  28. Mother’s instinct – a rare case of multiple test interferences due to heterophile antibodies
  29. Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs
  30. A national survey of preanalytical handling of oral glucose tolerance tests in pregnancy
  31. Updating pregnancy diabetes guidelines: is (y)our laboratory ready?
  32. Low serum bilirubin values are associated with pulmonary embolism in a case-control study
  33. Effect of Hb H on HbA1c measurements as measured by IFCC reference method and affinity HPLC
  34. Adipocytes in venipunctures cause falsely elevated S-100B serum values
  35. Earlier detection of sepsis by Candida parapsilosis using three-dimensional cytographic anomalies on the Mindray BC-6800 hematological analyzer
  36. Theranos phenomenon – part 4: Theranos at an International Conference
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