Startseite Allowable total error in CD34 cell analysis by flow cytometry based on state of the art using Spanish EQAS data
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Allowable total error in CD34 cell analysis by flow cytometry based on state of the art using Spanish EQAS data

  • Sara Fernández-Luis , Alejandra Comins-Boo ORCID logo , Fernando Pérez-Pla , Juan Irure-Ventura ORCID logo , Andrés Insunza Gaminde , Marcos López-Hoyos , Lydia Blanco-Peris , M. Carmen Martín Alonso und David San Segundo Arribas EMAIL logo
Veröffentlicht/Copyright: 18. November 2024
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 63 Heft 2

Abstract

Objectives

CD34+ hematopoietic stem cell (HSC) enumeration, crucial for HSC transplantation, is performed by flow cytometry to guide clinical decisions. Variability in enumeration arises from biological factors, assay components, and technology. External quality assurance schemes (EQAS) train participants to minimize inter-laboratory variations. The goal is to estimate total error (TE) values for CD34 cell enumeration using state-of-the-art (SOTA) methods with EQA data and to define quality specifications by comparing TE using different cutoffs.

Methods

A total of 3,994 results from 40 laboratories were collected over 11 years (2011–2022) as part of the IC-2 Stem Cells Scheme of the GECLID Program that includes absolute numbers of CD34 cells. The data were analyzed in two periods: 2011–2016 and 2017–2022. The TE value achieved by at least 60 %, 70 %, 80 %, and 90  % of laboratories was calculated across the two different periods and at various levels of CD34 cell counts: above 25, 25 to 15, and under 15 cells/μL.

Results

A decrease in the SOTA-based TE for CD34 cell enumeration was observed in the most recent period in 2017–2021 compared with 2012–2016. A significant increase of P75 TE values in the low CD34 range (<15 cells/μL) levels was found (p<0.001).

Conclusions

Technical advancements contribute to the decrease TE over time. The TE of CD34 cell FC counts is measure-dependent, making it responsive to precision enhancement strategies. The TE measured by EQAS in this study may serve as a quality specification for implementing ISO 15189 standards in clinical laboratories for CD34 cell enumeration.

Keywords: biological variability; allowable total error; CD34; proficiency testing; ISO15189; stem cells
Corresponding author: David San Segundo Arribas, Department of Immunology, Immunopathology Group, Marqués de Valdecilla University Hospital-IDIVAL, B-Tower, -1 floor, Avd Valdecilla s/n, CP 39008, Santander, Spain, E-mail:
M. Carmen Martín Alonso and David San Segundo Arribas share senior authorship. Sara Fernández-Luis and Alejandra Comins-Boo contributed equally to this work and share first authorship.

Acknowledgments

The authors want to acknowledge the Spanish Society for Immunology and the Iberian Society of Cytometry for their kind allowance to use EPT data, to every lab that took the interlaboratory comparisons over these 10 years for their contribution, and to all anonymous blood donors that consented to the use of their biological samples, as well as the Biobanco del Centro de Hemoterapia y Hemodonación de Castilla y León, that supplies the samples to the GECLID program.

  1. Research ethics: Not applicable.

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

  3. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  4. Author contributions: D.S.S., M.C.M.A.: contributed to the design of the project. D.S.S., F.P.P.: performed the analytic calculations, implemented the computer code, and performed supporting algorithms. S.F.L., D.S.S., A.C.B., A.I.G.: analyze the results and write the manuscript. M.C.M.A., S.F.L., A.I.G., J.I.V., M.L.H.: critical review, commentary, and revision. L.B.P., M.C.M.A.: provision of study materials. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  5. Conflict of interests: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: The raw data can be obtained on request from the corresponding author.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0956).

Received: 2024-08-16
Accepted: 2024-11-01
Published Online: 2024-11-18
Published in Print: 2025-01-29

© 2024 Walter de Gruyter GmbH, Berlin/Boston

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. CD34+ progenitor cells meet metrology
  4. Reviews
  5. Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems
  6. The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI): a meta-analysis
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  9. Clostebol and sport: about controversies involving contamination vs. doping offence
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  14. Comparative analysis of BCR::ABL1 p210 mRNA transcript quantification and ratio to ABL1 control gene converted to the International Scale by chip digital PCR and droplet digital PCR for monitoring patients with chronic myeloid leukemia
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  22. An immuno-DOT diagnostic assay for autoimmune nodopathy
  23. Evaluation of biochemical algorithms to screen dysbetalipoproteinemia in ε2ε2 and rare APOE variants carriers
  24. Reference Values and Biological Variations
  25. Allowable total error in CD34 cell analysis by flow cytometry based on state of the art using Spanish EQAS data
  26. Clinical utility of personalized reference intervals for CEA in the early detection of oncologic disease
  27. Agreement of lymphocyte subsets detection permits reference intervals transference between flow cytometry systems: direct validation using established reference intervals
  28. Cancer Diagnostics
  29. Atypical cells in urine sediment: a novel biomarker for early detection of bladder cancer
  30. External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA
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  32. Evaluation of the analytical and clinical performance of a high-sensitivity troponin I point-of-care assay in the Mersey Acute Coronary Syndrome Rule Out Study (MACROS-2)
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  34. Infectious Diseases
  35. Synovial fluid D-lactate – a pathogen-specific biomarker for septic arthritis: a prospective multicenter study
  36. Targeted MRM-analysis of plasma proteins in frozen whole blood samples from patients with COVID-19: a retrospective study
  37. Letters to the Editor
  38. Generative artificial intelligence (AI) for reporting the performance of laboratory biomarkers: not ready for prime time
  39. Urgent need to adopt age-specific TSH upper reference limit for the elderly – a position statement of the Belgian thyroid club
  40. Sigma metric is more correlated with analytical imprecision than bias
  41. Utility and limitations of monitoring kidney transplants using capillary sampling
  42. Simple flow cytometry method using a myeloma panel that easily reveals clonal proliferation of mature B-cells
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https://doi.org/10.1515/cclm-2024-0956
Schlagwörter für diesen Artikel
biological variability; allowable total error; CD34; proficiency testing; ISO15189; stem cells

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. CD34+ progenitor cells meet metrology
  4. Reviews
  5. Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems
  6. The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI): a meta-analysis
  7. Opinion Papers
  8. Advancing value-based laboratory medicine
  9. Clostebol and sport: about controversies involving contamination vs. doping offence
  10. Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement
  11. Perspectives
  12. An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results
  13. Genetics and Molecular Diagnostics
  14. Comparative analysis of BCR::ABL1 p210 mRNA transcript quantification and ratio to ABL1 control gene converted to the International Scale by chip digital PCR and droplet digital PCR for monitoring patients with chronic myeloid leukemia
  15. General Clinical Chemistry and Laboratory Medicine
  16. IVDCheckR – simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool
  17. Analytical performance specifications for trace elements in biological fluids derived from six countries federated external quality assessment schemes over 10 years
  18. The effects of drone transportation on routine laboratory, immunohematology, flow cytometry and molecular analyses
  19. Accurate non-ceruloplasmin bound copper: a new biomarker for the assessment and monitoring of Wilson disease patients using HPLC coupled to ICP-MS/MS
  20. Construction of platelet count-optical method reflex test rules using Micro-RBC#, Macro-RBC%, “PLT clumps?” flag, and “PLT abnormal histogram” flag on the Mindray BC-6800plus hematology analyzer in clinical practice
  21. Evaluation of serum NFL, T-tau, p-tau181, p-tau217, Aβ40 and Aβ42 for the diagnosis of neurodegenerative diseases
  22. An immuno-DOT diagnostic assay for autoimmune nodopathy
  23. Evaluation of biochemical algorithms to screen dysbetalipoproteinemia in ε2ε2 and rare APOE variants carriers
  24. Reference Values and Biological Variations
  25. Allowable total error in CD34 cell analysis by flow cytometry based on state of the art using Spanish EQAS data
  26. Clinical utility of personalized reference intervals for CEA in the early detection of oncologic disease
  27. Agreement of lymphocyte subsets detection permits reference intervals transference between flow cytometry systems: direct validation using established reference intervals
  28. Cancer Diagnostics
  29. Atypical cells in urine sediment: a novel biomarker for early detection of bladder cancer
  30. External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA
  31. Cardiovascular Diseases
  32. Evaluation of the analytical and clinical performance of a high-sensitivity troponin I point-of-care assay in the Mersey Acute Coronary Syndrome Rule Out Study (MACROS-2)
  33. Analytical verification of the Atellica VTLi point of care high sensitivity troponin I assay
  34. Infectious Diseases
  35. Synovial fluid D-lactate – a pathogen-specific biomarker for septic arthritis: a prospective multicenter study
  36. Targeted MRM-analysis of plasma proteins in frozen whole blood samples from patients with COVID-19: a retrospective study
  37. Letters to the Editor
  38. Generative artificial intelligence (AI) for reporting the performance of laboratory biomarkers: not ready for prime time
  39. Urgent need to adopt age-specific TSH upper reference limit for the elderly – a position statement of the Belgian thyroid club
  40. Sigma metric is more correlated with analytical imprecision than bias
  41. Utility and limitations of monitoring kidney transplants using capillary sampling
  42. Simple flow cytometry method using a myeloma panel that easily reveals clonal proliferation of mature B-cells
  43. Is sweat conductivity still a relevant screening test for cystic fibrosis? Participation over 10 years
  44. Hb D-Iran interference on HbA1c measurement
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