Home Measurement uncertainty of γ-glutamyltransferase (GGT) in human serum by four approaches using different quality assessment data
Article
Licensed
Unlicensed Requires Authentication

Measurement uncertainty of γ-glutamyltransferase (GGT) in human serum by four approaches using different quality assessment data

  • Rui Zhou , Yanyan Qin , Hongyi Yin , Yanmin Yang and Qingtao Wang EMAIL logo
Published/Copyright: August 15, 2017
Become an author with De Gruyter Brill
Submit Manuscript Author Information
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 2

Abstract

Background:

Measurement uncertainty (MU) characterizes the dispersion of the quantity values attributed to a measurand. Although this concept was introduced to medical laboratories some years ago, not all medical researchers are familiar with it. Therefore, the evaluation and expression of MU must be highlighted. In this paper, the evaluation of MU is described by using four different approaches from different quality assessment data.

Methods:

In accordance with Guide to the Expression of Uncertainty of Measurement (GUM) principles, human serum γ-glutamyltransferase (GGT) level was defined as the measurand. Main sources of MU were analyzed; individual components of MU were evaluated, followed by calculation of standard uncertainty, the combined standard uncertainty and the expanded uncertainty.

Results:

In method 1, the median of expanded uncertainty (k=2) of GGT in lower level (65±1 U/L) was 5 U/L (9%, 95% confidence interval) and in higher level (116±2 U/L) was 8% (95% confidence interval), respectively. The results of method 2 were lower than that of method 1. There were no significant differences between the two other methods compared with the method 1.

Conclusions:

Three out of the four different approaches based on different quality assessment data yielded similar results. Proficiency testing or external quality assessment data used for MU evaluation can be regarded as a supplementary method in clinical laboratory.

Keywords: bias; internal quality control; measurement uncertainty; proficiency testing; reproducibility

Acknowledgments

The authors thank Bao-rong Chen (Department of Clinical Laboratory, Beijing Aerospace General Hospital) for assigned values for CRMs by reference method.

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

  2. Research funding: This work was supported by National Clinical Key Specialty Construction Projects (QTW), the Beijing Capital Development Special Project for Health Research (2016-1-2031) titled “The establishment and evaluation on the standardization method of point-of-care HbA1c testing and on the method of HbA1c molecular typing by mass spectrometry at different level laboratories” and Beijing Municipal Administration of Hospitals entitled by “Investigation on the quality control and the study on countermeasures of continuous improvement of municipal hospitals”.

  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.

References

1. Joint Committee for Guides in Metrology. International vocabulary of metrology-basic and general concepts and associated terms (VIM). JCGM 2012;200.Search in Google Scholar

2. Evaluation of measurement data – Guide to the expression of uncertainty in measurement. GUM 1995 with minor corrections. Joint Committee for Guides in Metrology 2008;100.Search in Google Scholar

3. Matar G, Poggi B, Meley R, Bon C, Chardon L, Chikh K, et al. Uncertainty in measurement for 43 biochemistry, immunoassay, and hemostasis routine analytes evaluated by a method using only external quality assessment data. Clin Chem Lab Med 2015;53:1725–36.10.1515/cclm-2014-0942Search in Google Scholar PubMed

4. Farrance I, Frenkel R. Uncertainty of measurement: a review of the rules for relationships. Clin Biochem Rev 2012;33:49–75.Search in Google Scholar

5. Clinical and Laboratory Standards Institute. Expression of measurement uncertainty in laboratory medicine; approved guideline. CLSI document EP29-A. Wayne, PA: CLSI, 2012.Search in Google Scholar

6. ISO15189: medical laboratories-requirements for quality and competence, 3rd ed. Geneva: International Organization for Standardization (ISO), 2012.Search in Google Scholar

7. ISO 17025: General requirements for the competence of testing and calibration laboratories. Geneva: International Organization for Standardization (ISO), 2005.Search in Google Scholar

8. ISO 21748:2010: Guide to the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation. Geneva: International Organization for Standardization (ISO), 2010.Search in Google Scholar

9. Panteghini M. Application of traceability concepts to analytical quality control may reconcile total error with uncertainty of measurement. Clin Chem Lab Med 2010;48:7–10.10.1515/CCLM.2010.020Search in Google Scholar PubMed

10. Krouwer JS. Uncertainty intervals based on deleting data are not useful. Clin Chem 2006;52:1204–5.10.1373/clinchem.2006.069591Search in Google Scholar PubMed

11. Krouwer JS. Critique of the guide to the expression of uncertainty in measurement method of estimating and reporting uncertainty in diagnostic assays. Clin Chem 2003;49:1818–21.10.1373/clinchem.2003.019505Search in Google Scholar PubMed

12. Kristiansen J. The guide to expression of uncertainty in measurement approach for estimating uncertainty: an appraisal. Clin Chem 2003;49:1822–9.10.1373/clinchem.2003.021469Search in Google Scholar PubMed

13. Westgard SA. MU survey 2015: the global results. Available at: http://www.westgard.com/mu-global-survey.htm. Accessed: Dec 2015.Search in Google Scholar

14. Magnusson B, Naykki T, Hovind H, Krysell M. Handbook for calculation of measurement uncertainty in environmental laboratories. NT TR 537 – Edition 3.1. Oslo, Norway: Nordic Innovation, 2012.Search in Google Scholar

15. Lee JH, Choi JH, Youn JS, Cha YJ, Song W, Park AJ. Comparison between bottom-up and top-down approaches in the estimation of measurement uncertainty. Clin Chem Lab Med 2015;53:1025–32.10.1515/cclm-2014-0801Search in Google Scholar PubMed

16. Chen H, Zhang L, Bi X, Deng X. Two evaluation budgets for the measurement uncertainty of glucose in clinical chemistry. Korean J Lab Med 2011;31:167–71.10.3343/kjlm.2011.31.3.167Search in Google Scholar PubMed PubMed Central

17. Ceriotti F, Brugnoni D, Mattioli S. How to define a significant deviation from the expected internal quality control result. Clin Chem Lab Med 2015;53:913–8.10.1515/cclm-2014-1149Search in Google Scholar PubMed

18. Theodorsson E, Magnusson B, Leito I. Bias in clinical chemistry. Bioanalysis 2014;6:2855–75.10.4155/bio.14.249Search in Google Scholar PubMed

19. Schumann G, Bonora R, Ceriotti F, Férard G, Ferrero CA, Franck PF, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International federation of clinical chemistry and laboratory medicine. Part 6. Reference procedure for the measurement of catalytic concentration of gamma-glutamyl-transferase. Clin Chem Lab Med 2002;40:734–8.Search in Google Scholar

20. ISO 13528: Statistical methods for use in proficiency testing by interlaboratory comparisons. Geneva: International Organization for Standardization (ISO), 2005.Search in Google Scholar

21. ISO 17043: Conformity assessment – general requirements for proficiency testing. Geneva: International Organization for Standardization (ISO), 2010.Search in Google Scholar

22. CNAS-TRL-001: The evaluation and expression of measurement uncertainty in medical laboratory. China: China national accreditation service for conformity assessment (CNAS), 2012.Search in Google Scholar

23. Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Current databases on biologic variation: pros, cons and progress. Scand J Clin Lab Invest 1999;59:491–500.10.1080/00365519950185229Search in Google Scholar PubMed

24. Braga F, Infusino I, Panteghini M. Performance criteria for combined uncertainty budget in the implementation of metrological traceability. Clin Chem Lab Med 2015;53:905–12.10.1515/cclm-2014-1240Search in Google Scholar PubMed

25. Clinical Laboratory Standard Institute C24A3. Statistical quality control for quantitative measurement procedures: principles and definitions. Wayne, PA: CLSI, 2006.Search in Google Scholar

26. Ceriotti F. The role of external quality assessment schemes in monitoring and improving the standardization process. Clin Chim Acta 2014;432:77–81.10.1016/j.cca.2013.12.032Search in Google Scholar PubMed

27. Measurement uncertainty revisited: alternative approaches to uncertainty evaluation. European federation of national associations of measurement, testing and analytical laboratories, EUROLAB. Technical Report No. 1/2007.Search in Google Scholar

Received: 2017-06-09
Accepted: 2017-06-25
Published Online: 2017-08-15
Published in Print: 2018-01-26

©2018 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Need for better PTH assays for clinical research and patient treatment
  4. Reviews
  5. Liquid biopsy in ovarian cancer: recent advances on circulating tumor cells and circulating tumor DNA
  6. Hair testing of GHB: an everlasting issue in forensic toxicology
  7. Opinion Paper
  8. The use of error and uncertainty methods in the medical laboratory
  9. Genetics and Molecular Diagnostics
  10. Results of the first external quality assessment scheme (EQA) for isolation and analysis of circulating tumour DNA (ctDNA)
  11. The importance of biochemical and genetic findings in the diagnosis of atypical Norrie disease
  12. General Clinical Chemistry and Laboratory Medicine
  13. Various glycolysis inhibitor-containing tubes for glucose measurement cannot be used interchangeably due to clinically unacceptable biases between them
  14. Measurement uncertainty of γ-glutamyltransferase (GGT) in human serum by four approaches using different quality assessment data
  15. Oxidation of PTH: in vivo feature or effect of preanalytical conditions?
  16. A comparison between high resolution serum protein electrophoresis and screening immunofixation for the detection of monoclonal gammopathies in serum
  17. The key incident monitoring and management system – history and role in quality improvement
  18. Is it necessary for all samples to quantify 25OHD2 and 25OHD3 using LC-MS/MS in clinical practice?
  19. Contamination of dried blood spots – an underestimated risk in newborn screening
  20. Comparative study of the diagnostic and prognostic value of antibodies against chimeric citrullinated synthetic peptides and CCP3/CCP3.1 assays
  21. Development and validation of a multivariable prediction rule for detecting a severe acquired ADAMTS13 activity deficiency in patients with thrombotic microangiopathies
  22. Use of the sFlt-1/PlGF ratio to rule out preeclampsia requiring delivery in women with suspected disease. Is the evidence reproducible?
  23. Evaluation of a new free light chain ELISA assay: bringing coherence with electrophoretic methods
  24. Hematology and Coagulation
  25. The frequency of occurrence of fish-shaped red blood cells in different haematologic disorders
  26. Reference Values and Biological Variations
  27. Pediatric reference intervals for 29 Ortho VITROS 5600 immunoassays using the CALIPER cohort of healthy children and adolescents
  28. Cancer Diagnostics
  29. Prevalence and causes of abnormal PSA recovery
  30. Cardiovascular Diseases
  31. Serum omentin-1 is a novel biomarker for predicting the functional outcome of acute ischemic stroke patients
  32. Letters to the Editor
  33. BD Vacutainer® Barricor tube in the emergency department: reduced hemolysis rates using partial draw tubes with reduced vacuum
  34. The risk of unjustified BRCA testing after the “Angelina Jolie effect”: how can we save (laboratory) medicine from the Internet?
  35. Sweat travels: the issue of sweat chloride transportation
  36. Individual values of antineutrophil cytoplasmic antibodies do not correspond between antigen-specific assays
  37. False negative results caused by erroneous automated result interpretation algorithm on the FilmArray 2.0 instrument
  38. Quantification of 1,25-dihydroxyvitamin D – value of manufacturers’ product information
  39. Interference between ethosuximide and barbiturates in an immunochromatographic method
  40. In vivo interference of Ioversol in serum and urine capillary electrophoresis: an optimized protocol for sample collection
  41. Evaluation of the new Elecsys SCC assay: comparison with the Kryptor SCC assay
  42. Congress Abstracts
  43. 9th National Congress of the Portuguese Society of Clinical Chemistry, Genetics and Laboratory Medicine
  44. ACBI 2017 40TH Annual Conference
https://doi.org/10.1515/cclm-2017-0511
Keywords for this article
bias; internal quality control; measurement uncertainty; proficiency testing; reproducibility

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Need for better PTH assays for clinical research and patient treatment
  4. Reviews
  5. Liquid biopsy in ovarian cancer: recent advances on circulating tumor cells and circulating tumor DNA
  6. Hair testing of GHB: an everlasting issue in forensic toxicology
  7. Opinion Paper
  8. The use of error and uncertainty methods in the medical laboratory
  9. Genetics and Molecular Diagnostics
  10. Results of the first external quality assessment scheme (EQA) for isolation and analysis of circulating tumour DNA (ctDNA)
  11. The importance of biochemical and genetic findings in the diagnosis of atypical Norrie disease
  12. General Clinical Chemistry and Laboratory Medicine
  13. Various glycolysis inhibitor-containing tubes for glucose measurement cannot be used interchangeably due to clinically unacceptable biases between them
  14. Measurement uncertainty of γ-glutamyltransferase (GGT) in human serum by four approaches using different quality assessment data
  15. Oxidation of PTH: in vivo feature or effect of preanalytical conditions?
  16. A comparison between high resolution serum protein electrophoresis and screening immunofixation for the detection of monoclonal gammopathies in serum
  17. The key incident monitoring and management system – history and role in quality improvement
  18. Is it necessary for all samples to quantify 25OHD2 and 25OHD3 using LC-MS/MS in clinical practice?
  19. Contamination of dried blood spots – an underestimated risk in newborn screening
  20. Comparative study of the diagnostic and prognostic value of antibodies against chimeric citrullinated synthetic peptides and CCP3/CCP3.1 assays
  21. Development and validation of a multivariable prediction rule for detecting a severe acquired ADAMTS13 activity deficiency in patients with thrombotic microangiopathies
  22. Use of the sFlt-1/PlGF ratio to rule out preeclampsia requiring delivery in women with suspected disease. Is the evidence reproducible?
  23. Evaluation of a new free light chain ELISA assay: bringing coherence with electrophoretic methods
  24. Hematology and Coagulation
  25. The frequency of occurrence of fish-shaped red blood cells in different haematologic disorders
  26. Reference Values and Biological Variations
  27. Pediatric reference intervals for 29 Ortho VITROS 5600 immunoassays using the CALIPER cohort of healthy children and adolescents
  28. Cancer Diagnostics
  29. Prevalence and causes of abnormal PSA recovery
  30. Cardiovascular Diseases
  31. Serum omentin-1 is a novel biomarker for predicting the functional outcome of acute ischemic stroke patients
  32. Letters to the Editor
  33. BD Vacutainer® Barricor tube in the emergency department: reduced hemolysis rates using partial draw tubes with reduced vacuum
  34. The risk of unjustified BRCA testing after the “Angelina Jolie effect”: how can we save (laboratory) medicine from the Internet?
  35. Sweat travels: the issue of sweat chloride transportation
  36. Individual values of antineutrophil cytoplasmic antibodies do not correspond between antigen-specific assays
  37. False negative results caused by erroneous automated result interpretation algorithm on the FilmArray 2.0 instrument
  38. Quantification of 1,25-dihydroxyvitamin D – value of manufacturers’ product information
  39. Interference between ethosuximide and barbiturates in an immunochromatographic method
  40. In vivo interference of Ioversol in serum and urine capillary electrophoresis: an optimized protocol for sample collection
  41. Evaluation of the new Elecsys SCC assay: comparison with the Kryptor SCC assay
  42. Congress Abstracts
  43. 9th National Congress of the Portuguese Society of Clinical Chemistry, Genetics and Laboratory Medicine
  44. ACBI 2017 40TH Annual Conference
Sign up now to receive a 20% welcome discount
Institutional Access
How does access work?
Have an idea on how to improve our website?
Please write us.
© 2025 De Gruyter Brill
Downloaded on 15.9.2025 from https://www.degruyterbrill.com/document/doi/10.1515/cclm-2017-0511/html
Scroll to top button