Uncertainty evaluation in clinical chemistry, immunoassay, hematology and coagulation analytes using only external quality assessment data

Yanyan Qin; Rui Zhou; Wei Wang; Hongyi Yin; Yanmin Yang; Yuhong Yue; Qing Tong; Lu Liu; Yali Jin; Yankun Shi; Shunli Zhang; Jianping Zhang; Rui Zhang; Chang Zuo; Tingting Jia; Ning Wang; Qingtao Wang

doi:10.1515/cclm-2017-1199

Article

Uncertainty evaluation in clinical chemistry, immunoassay, hematology and coagulation analytes using only external quality assessment data

Yanyan Qin , Rui Zhou , Wei Wang , Hongyi Yin , Yanmin Yang , Yuhong Yue , Qing Tong , Lu Liu , Yali Jin , Yankun Shi , Shunli Zhang , Jianping Zhang , Rui Zhang , Chang Zuo , Tingting Jia , Ning Wang and Qingtao Wang

Published/Copyright: April 23, 2018

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 9

Abstract

Background:

Measurement uncertainty (MU) is a parameter associated with the result of a measurement that characterizes its dispersion. We report results for estimating MU following the application of a top-down procedure using only proficiency test data to establish uncertainty levels for various analytes.

Methods:

Data were obtained from 142 laboratories participating in the Beijing Center for Clinical Laboratory (BCCL) proficiency testing/external quality assessment (PT/EQA) schemes. The 24-month study included six selected PT shipments to obtain estimates for 50th percentile (median) and 90th percentile MUs and to compare those estimates to usual analytic goals. The number of laboratory participants varied for each trial. The expanded uncertainty (U) was calculated using a cover factor of k=2 for a confidence interval of 95%. All reproducibility, method and laboratory biases came from the PT/EQA data.

Results:

The median U (k=2) ranged from 3.2% (plasma sodium, indirect ion selective electrode) to 32.8% (triglycerides, free glycerol blanking) for clinical chemistry analyte means from participants in the same method group. Immunoassay analyte median U results ranged from 11.3% (CA125 tumor marker, Roche) to 33.8% (prostate-specific antigen [PSA], Abbott). The range for median U was 3.5% (red blood cell [RBC], Abx) to 30.3% (fibrinogen [FBG], other) for hematology and coagulation analytes. The MUs for most analytes satisfied quality requirements.

Conclusions:

The use of PT/EQA data, when available, provides an effective means for estimating uncertainties associated with quantitative measurements. Thus, medical laboratories can calculate their own MUs. Proficiency testing organizers can provide participants with an additional MU estimate using only EQA data, which may be updated at the end of each survey.

Keywords: bias; measurement uncertainty; proficiency testing/external quality assessment; reproducibility; standardized

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: This work was supported by several funding programs: the National Natural Science Foundation of China (No. 81672074) for “The establishment of reference measurement system based on ID-LC/MS for glycated albumin and research about application in diagnosis of DM”; the National Clinical Key Specialty Construction Projects; the Beijing Capital Development Special Project for Health Research (2016-1-2031) for “The establishment and evaluation on the standardization method of point-of care HbA_1c testing and on the method of HbA_1c molecular typing by mass spectrometry at different level laboratories”; and the Beijing Municipal Administration of Hospitals for “Investigation on the quality control and the study on countermeasures of continuous improvement of municipal hospitals.”
Employment or leadership: None declared.
Honorarium: None declared.
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. JCGM. International vocabulary of metrology-basic and general concepts and associated terms (VIM), 200:2012.Search in Google Scholar

2. Dallas Jones GR. Measurement uncertainty for clinical laboratories – a revision of the concept. Clin Chem Lab Med 2016;54:1303–7.10.1515/cclm-2016-0311Search in Google Scholar PubMed

3. 15189: Medical laboratories-particular requirements for quality and competence. Geneva: International Organization for Standardization (ISO), 2012.Search in Google Scholar

4. Fuentes AX. Uncertainty of measurement in clinical microbiology. In: eJIFCC 2004;13. Available from: http://www.ifcc.org/ifccfiles/docs/130401006.pdf. Accessed: Dec 2016.Search in Google Scholar

5. International Laboratory Accreditation Cooperation (ILAC). ILAC G-17:2002. Available from: http://www.ilac.org. Accessed: Dec 2016.Search in Google Scholar

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

7. 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

8. 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

9. 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

10. CNAS-TRL-001: Evaluation and Expression of Measurement Uncertainty in the Medical Laboratory, China: China national accreditation service for conformity assessment (CNAS), 2012.Search in Google Scholar

11. Companyo R, Rubio R, Sahuquillo A, Boque R, Maroto A, Riu J. Uncertainty estimation in organic elemental analysis using information from proficiency tests. Anal Bioanal Chem 2008;392:1497–505.10.1007/s00216-008-2438-5Search in Google Scholar PubMed

12. Jarvis B, Corry JE, Hedges AJ. Estimates of measurement uncertainty from proficiency testing schemes, internal laboratory quality monitoring and during routine enforcement examination of foods. J Appl Microbiol 2007;103:462–7.10.1111/j.1365-2672.2006.03258.xSearch in Google Scholar PubMed

13. Rodomonte AL, Montinaro A, Bartolomei M. Uncertainty evaluation in the chloroquine phosphate potentiometric titration: application of three different approaches. J Pharm Biomed Anal 2006;42:56–63.10.1016/j.jpba.2006.05.026Search in Google Scholar PubMed

14. EUROLAB Technical Report N.1/2007. Measurement uncertainty revisited:alternative approaches to uncertainty evaluation, Technical Committee for Quality Assurance in Testing (TCQA), Paris, France, 2007.Search in Google Scholar

15. Meijer P, de Maat MP, Kluft C, Haverkate F, van Houwelingen HC. Long-term analytical performance of hemostasis field methods as assessed by evaluation of the results of an external quality assessment program for antithrombin. Clin Chem 2002;48:1011–5.10.1093/clinchem/48.7.1011Search in Google Scholar

16. ISO13528: Statistical methods for use in proficiency testing by interlaboratory comparisons. Geneva: International Organization for Standardization (ISO), 2005.Search in Google Scholar

17. ISO17043: Conformity assessment-general requirements for proficiency testing. Geneva: International Organization for Standardization (ISO), 2010.Search in Google Scholar

18. CLIA Proficiency Testing Criteria, Fed. Regist. 57(40) (February 28, 1992) 7002–7186 (See also www.westgard.com/clia.htm).Search in Google Scholar

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

20. Padoan A, Antonelli G, Aita A, Sciacovelli L, Plebani M. An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes. Clin Chem Lab Med 2017;55:1696–701.10.1515/cclm-2016-0896Search in Google Scholar PubMed

21. 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

22. Zhou R, Qin Y, Yin H, Yang Y, Wang Q. Measurement uncertainty of gamma-glutamyltransferase (GGT) in human serum by four approaches using different quality assessment data. Clin Chem Lab Med 2018;56:242–8.10.1515/cclm-2017-0511Search in Google Scholar PubMed

Received: 2017-12-22

Accepted: 2018-03-13

Published Online: 2018-04-23

Published in Print: 2018-08-28

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Articles in the same Issue

https://doi.org/10.1515/cclm-2017-1199

Keywords for this article

bias; measurement uncertainty; proficiency testing/external quality assessment; reproducibility; standardized