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Study of total error specifications of lymphocyte subsets enumeration using China National EQAS data and Biological Variation Data Critical Appraisal Checklist (BIVAC)-compliant publications

  • Chenbin Li ORCID logo , Yu Wang , Hong Lu , Zhongli Du , Chengshan Xu and Mingting Peng EMAIL logo
Published/Copyright: July 22, 2020
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 59 Issue 1

Abstract

Objectives

It is important to select proper quality specifications for laboratories and external quality assessment (EQA) providers for their quality control and assessment. The aim of this study is to produce new total error (TE) specifications for lymphocyte subset enumeration by analyzing the allowable TE using EQAS data and comparing them with that based on reliable biological variation (BV).

Methods

A total of 54,400 results from 1,716 laboratories were collected from China National EQAS for lymphocyte subset enumeration during the period 2017–2019. The EQA data were grouped according to lower limits of reference intervals for establishing concentration-dependent specifications. The TE value that 80% of laboratories can achieve were considered as TE specifications based on state of the art. The BV studies compliant with Biological Variation Data Critical Appraisal Checklist (BIVAC) were used to calculate the three levels of TE specifications. Then these TE specifications were compared for determining the recommended TE specifications.

Results

Four parameters whose quality specifications could achieve the optimum criteria were as follows: the percentages of CD3+, CD3+CD4+ (high concentration) and CD3–CD16/56+ cells, and the absolute count of CD3–CD16/56+ cells. Only the TE specifications of CD3–CD19+ cells could achieve the minimum criteria. The TE specifications of remaining parameters should reach the desirable criteria.

Conclusions

New TE specifications were established by combining the EQA data and reliable BV data, which could help laboratories to apply proper criteria for continuous improvement of quality control, and EQA providers to use robust acceptance limits for better evaluation of EQAS results.

Keywords: biological variation; external quality assessment; lymphocyte subset enumeration; state of the art; total error
Corresponding author: Prof. Mingting Peng, National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, P.R. China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, P.R. China; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, P.R. China; and Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, P.R. China, E-mail:
Chenbin Li and Yu Wang: contributed equally to this work.

Funding source: Ministry of Science and Technology of China

Award Identifier / Grant number: 2013FY113800

Funding source: National key research and development program

Award Identifier / Grant number: 2017YFC0910003

Funding source: National Natural Science Foundation of China

Award Identifier / Grant number: 81772254

  1. Research funding: The work was supported by the research fund of National Special Project of Science and Technology Basic Work of Ministry of Science and Technology of China (Grant No. 2013FY113800), National key research and development program (Grant No. 2017YFC0910003) and National Natural Science Foundation of China (Grant No. 81772254).

  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.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-0741).

Received: 2020-05-17
Accepted: 2020-06-19
Published Online: 2020-07-22
Published in Print: 2021-01-26

© 2020 Walter de Gruyter GmbH, Berlin/Boston

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  41. Acknowledgment
  42. Letter to the Editors
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  46. Performance of perpendicular drop versus tangent skimming gating of M-protein in proficiency testing challenges
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https://doi.org/10.1515/cclm-2020-0741
Keywords for this article
biological variation; external quality assessment; lymphocyte subset enumeration; state of the art; total error

Articles in the same Issue

  1. 10.1515/cclm-2020-frontmatter1
  2. Mario Plebani turns 70
  3. Editorial
  4. Measurement uncertainty and the importance of correlation
  5. Reviews
  6. Untangling the association between prostate-specific antigen and diabetes: a systematic review and meta-analysis
  7. The emerging role of cell senescence in atherosclerosis
  8. Mini Review
  9. Minimum retesting intervals in practice: 10 years experience
  10. Opinion Paper
  11. Cardiotoxic effects and myocardial injury: the search for a more precise definition of drug cardiotoxicity
  12. EFLM Papers
  13. The CRESS checklist for reporting stability studies: on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)
  14. Thoughts and expectations of young professionals about the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
  15. Guidelines and Recommendations
  16. Evidence on clinical relevance of cardiovascular risk evaluation in the general population using cardio-specific biomarkers
  17. Genetics and Molecular Diagnostics
  18. A systematic evaluation of stool DNA preparation protocols for colorectal cancer screening via analysis of DNA methylation biomarkers
  19. General Clinical Chemistry and Laboratory Medicine
  20. The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care
  21. Evaluation of serum electrolytes measurement through the 6-year trueness verification program in China
  22. Feasibility for aggregation of commutable external quality assessment results to evaluate metrological traceability and agreement among results
  23. Sample size and rejection limits for detecting reagent lot variability: analysis of the applicability of the Clinical and Laboratory Standards Institute (CLSI) EP26-A protocol to real-world clinical chemistry data
  24. Effects of calcium dobesilate (CaD) interference on serum creatinine measurements: a national External Quality Assessment (EQA)-based educational survey of drug-laboratory test interactions
  25. Mass spectrometric sample identification with indicator compounds introduced via labeled sample tubes
  26. Automation and validation of a MALDI-TOF MS (Mass-Fix) replacement of immunofixation electrophoresis in the clinical lab
  27. A new strategy implementing mass spectrometry in the diagnosis of congenital disorders of N-glycosylation (CDG)
  28. Analytical evaluation of four faecal immunochemistry tests for haemoglobin
  29. Reference Values and Biological Variations
  30. Study of total error specifications of lymphocyte subsets enumeration using China National EQAS data and Biological Variation Data Critical Appraisal Checklist (BIVAC)-compliant publications
  31. Mass spectrometric quantification of urinary 6-sulfatoxymelatonin: age-dependent excretion and biological variation
  32. Establishment of international autoantibody reference standards for the detection of autoantibodies directed against PML bodies, GW bodies, and NuMA protein
  33. Hematology and Coagulation
  34. Appropriate thresholds for accurate screening for β-thalassemias in the newborn period: results from a French center for newborn screening
  35. Cardiovascular Diseases
  36. Analysis of B-type natriuretic peptide impurities using label-free data-independent acquisition mass spectrometry technology
  37. Diabetes
  38. Hemoglobin variants in southern China: results obtained during the measurement of glycated hemoglobin in a large population
  39. Potential of MALDI-TOF mass spectrometry to overcome the interference of hemoglobin variants on HbA1c measurement
  40. Acknowledgment
  41. Acknowledgment
  42. Letter to the Editors
  43. Measurement uncertainty estimation for derived biological quantities
  44. Non-reproducible cardiac troponin results occurring with a particular reagent lot
  45. Successfully meeting analytical expectations for the fast 0/1-h algorithm for NSTEMI by internal control procedures for cardiac troponin T
  46. Performance of perpendicular drop versus tangent skimming gating of M-protein in proficiency testing challenges
  47. Analytical evaluation of Reebio procalcitonin latex-enhanced immunoturbidimetric assay on the HITACHI Labospect 008AS
  48. Assessment of intraindividual agreement in prolactin results after post-polyethylene glycol precipitation test for the estimation of macroprolactin. Should the precipitation procedure be repeated in the same patient?
  49. Aggregation kinetic and temperature optimum of an EDTA-dependent pseudothrombocytopenia
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