Commutability assessment of reference materials for the enumeration of lymphocyte subsets

Chenbin Li; Mingting Peng; Dongsheng Xu; Hong Lu; Wenbin Zhou; Yanhong Liu; Xiuli Liu; Wenxiang Chen

doi:10.1515/cclm-2018-0915

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Article

Commutability assessment of reference materials for the enumeration of lymphocyte subsets

Chenbin Li , Mingting Peng , Dongsheng Xu , Hong Lu , Wenbin Zhou , Yanhong Liu , Xiuli Liu and Wenxiang Chen

Published/Copyright: December 20, 2018

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 57 Issue 5

Abstract

Background

Flow cytometric enumeration of lymphocyte subsets in peripheral blood can provide important information about immune status. Commutable reference materials (RM) are crucial for maintaining accurate and comparable measurement results over time and space. Commutability assessment of RMs for lymphocyte subsets enumeration has not been reported elsewhere.

Methods

Lymphocyte subsets were measured in triplicate on 56 patient samples and eight RMs using two measuring systems commonly used in laboratories (FACS Canto II and Cytomics FC500). The first step was to determine the suitability of RMs and comparability of different systems with patient samples. After the requirements of suitability and comparability were met, the second step was to assess commutability following regression approach and difference in bias approach.

Results

Two RMs were not measurable on FC500 system for CD3-CD16/56+ and CD3-CD19+ percentages. The results of comparability showed no significant difference in the two systems. Eight RMs for CD3+CD4+ cell count, six RMs for CD3+ and CD3+CD8+ percentages, five RMs for CD3-CD16/56+ percentage, and three RMs for CD3-CD19+ percentage were commutable using the two approaches. For CD3+, CD3+CD8+ and CD3-CD19+ percentages, the results of regression approach showed that one RM was non-commutable for each parameter, while the other approach showed that the RM was commutable.

Conclusions

The suitability of RM and comparability of different measuring systems are prerequisites for assessing commutability. This study indicated that different approaches led to different results. The difference in bias approach is recommended for criteria relating to medical requirements and performance characteristics of measuring systems in use.

Keywords: commutability; flow cytometry; lymphocyte subset; reference material

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: National Special Project of Science and Technology Basic Work of Ministry of Science and Technology of China, Grant Number: 2013FY113800.
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. Levering WH, van Wieringen WN, Kraan J, van Beers WA, Sintnicolaas K, van Rhenen DJ, et al. Flow cytometric lymphocyte subset enumeration: 10 years of external quality assessment in the Benelux countries. Cytometry B Clin Cytom 2008;74:79–90.10.1002/cyto.b.20370Search in Google Scholar PubMed

2. Deprez L, Toussaint B, Zegers I, Schimmel H, Grote-Koska D, Klauke R, et al. Commutability assessment of candidate reference materials for pancreatic alpha-amylase. Clin Chem 2018;64:1193–202.10.1373/clinchem.2018.289744Search in Google Scholar PubMed

3. Carobene A, Ceriotti F, Infusino I, Frusciante E, Panteghini M. Evaluation of the impact of standardization process on the quality of serum creatinine determination in Italian laboratories. Clin Chim Acta 2014;427:100–6.10.1016/j.cca.2013.10.001Search in Google Scholar PubMed

4. Korzun WJ, Nilsson G, Bachmann LM, Myers GL, Sakurabayashi I, Nakajima K, et al. Difference in bias approach for commutability assessment: application to frozen pools of human serum measured by 8 direct methods for HDL and LDL cholesterol. Clin Chem 2015;61:1107–13.10.1373/clinchem.2015.240861Search in Google Scholar PubMed

5. Bjerke M, Andreasson U, Kuhlmann J, Portelius E, Pannee J, Lewczuk P, et al. Assessing the commutability of reference material formats for the harmonization of amyloid-beta measurements. Clin Chem Lab Med 2016;54:1177–91.10.1515/cclm-2015-0733Search in Google Scholar PubMed

6. Jansen R, Jassam N, Thomas A, Perich C, Fernandez-Calle P, Faria AP, et al. A category 1 EQA scheme for comparison of laboratory performance and method performance: an international pilot study in the framework of the Calibration 2000 project. Clin Chim Acta 2014;432:90–8.10.1016/j.cca.2013.11.003Search in Google Scholar PubMed

7. Robijns K, Boone NW, Jansen RT, Kuypers AW, Neef C, Touw DJ. Commutability of proficiency testing material containing tobramycin: a study within the framework of the Dutch Calibration 2.000 project. Clin Chem Lab Med 2017;55:212–7.10.1515/cclm-2015-1254Search in Google Scholar PubMed

8. Ding T, Bergeron M, Seely P, Yang X, Diallo TO, Plews M, et al. Compatibility of stabilized whole blood products with CD4 technologies and their suitability for quality assessment programs. PLoS One 2014;9:e103391.10.1371/journal.pone.0103391Search in Google Scholar PubMed PubMed Central

9. CLSI. Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline. CLSI document EP30-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2010.Search in Google Scholar

10. Nilsson G, Budd JR, Greenberg N, Delatour V, Rej R, Panteghini M, et al. IFCC Working Group Recommendations for Assessing Commutability Part 2: using the difference in bias between a reference material and clinical samples. Clin Chem 2018;64:455–64.10.1373/clinchem.2017.277541Search in Google Scholar PubMed PubMed Central

11. Glencross D, Scott LE, Jani IV, Barnett D, Janossy G. CD45-assisted PanLeucogating for accurate, cost-effective dual-platform CD4+ T-cell enumeration. Cytometry 2002;50:69–77.10.1002/cyto.10068Search in Google Scholar PubMed

12. CLSI. Measurement procedure comparison and bias estimation using patient samples; Approved Guideline – Third Edition. CLSI document EP09-A3. Wayne, PA: Clinical Laboratory Standards Institute, 2013.Search in Google Scholar

13. Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb) 2015;25:141–51.10.11613/BM.2015.015Search in Google Scholar PubMed PubMed Central

14. U.S. National Institutes of Health. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Available at: https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/458/plasma-hiv-1-rna--viral-load--and-cd4-count-monitoring. Accessed: Aug 14th.Search in Google Scholar

15. Tosato F, Bernardi D, Sanzari MC, Pantano G, Plebani M. Biological variability of lymphocyte subsets of human adults’ blood. Clin Chim Acta 2013;424:159–63.10.1016/j.cca.2013.06.001Search in Google Scholar PubMed

16. Miller WG, Myers GL. Commutability still matters. Clin Chem 2013;59:1291–3.10.1373/clinchem.2013.208785Search in Google Scholar PubMed

17. Miller WG. The role of proficiency testing in achieving standardization and harmonization between laboratories. Clin Biochem 2009;42:232–5.10.1016/j.clinbiochem.2008.09.004Search in Google Scholar PubMed

18. Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem 2011;57:1670–80.10.1373/clinchem.2011.168641Search in Google Scholar PubMed

19. World Health Organization. WHO Expert Committee on Biological Standardization: Sixty-First Report. Available at: http://www.who.int/biologicals/expert_committee/TRS_978_61st_report.pdf. Accessed: 14 Aug 2018.Search in Google Scholar

20. BIPM. JCTLM-WG1 Quality Manual. Available at: https://www.bipm.org/en/committees/jc/jctlm/jctlm-wg1/wg1_quality-manual.html. Accessed: 23 Aug 2018.Search in Google Scholar

21. UK NEQAS for Leucocyte Immunophenotyping. Immune Monitoring (Alternative Technologies). Available at: http://www.ukneqasli.co.uk/eqa-pt-programmes/flow-cytometry-programmes/immune-monitoring-alternative-technologies/. Accessed: 14 Aug 2018.Search in Google Scholar

22. Hayden RT, Preiksaitis J, Tong Y, Pang X, Sun Y, Tang L, et al. Commutability of the First World Health Organization International Standard for human cytomegalovirus. J Clin Microbiol 2015;53:3325–33.10.1128/JCM.01495-15Search in Google Scholar PubMed PubMed Central

23. Carobene A, Guerra E, Ceriotti F. A mechanism-based way to evaluate commutability of control materials for enzymatic measurements. The example of gamma-glutamyltransferase. Clin Chim Acta 2013;424:153–8.10.1016/j.cca.2013.06.012Search in Google Scholar PubMed

24. Zhang S, Zeng J, Zhang C, Li Y, Zhao H, Cheng F, et al. Commutability of possible external quality assessment materials for cardiac troponin measurement. PLoS One 2014;9:e102046.10.1371/journal.pone.0102046Search in Google Scholar PubMed PubMed Central

25. Ceriotti F, Fernandez-Calle P, Klee GG, Nordin G, Sandberg S, Streichert T, et al. Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference. Clin Chem Lab Med 2017;55:189–94.10.1515/cclm-2017-0772Search in Google Scholar PubMed

26. Aarsand AK, Roraas T, Fernandez-Calle P, Ricos C, Diaz-Garzon J, Jonker N, et al. The Biological Variation Data Critical Appraisal Checklist: A Standard for Evaluating Studies on Biological Variation. Clin Chem 2018;64:501–14.10.1373/clinchem.2017.281808Search in Google Scholar PubMed

27. Bratescu A, Teodorescu M. Circannual variations in the B cell/T cell ratio in normal human peripheral blood. J Allergy Clin Immunol 1981;68:273–80.10.1016/0091-6749(81)90151-2Search in Google Scholar

28. Abo T, Miller CA, Cloud GA, Blach CM. Annual stability in the levels of lymphocyte subpopulations identified by monoclonal antibodies in blood of healthy individuals. J Clin Immunol 1985;5:13–20.10.1007/BF00915163Search in Google Scholar PubMed

29. Ritchie AW, Oswald I, Micklem HS, Boyd JE, Elton RA, Jazwinska E, et al. Circadian variation of lymphocyte subpopulations: a study with monoclonal antibodies. Br Med J (Clin Res Ed) 1983;286:1773–5.10.1136/bmj.286.6380.1773Search in Google Scholar PubMed PubMed Central

30. Backteman K, Ledent E, Berlin G, Ernerudh J. A rapid and reliable flow cytometric routine method for counting leucocytes in leucocyte-depleted platelet concentrates. Vox Sang 2002;83:29–34.10.1046/j.1423-0410.2002.00196.xSearch in Google Scholar PubMed

31. Backteman K, Ernerudh J. Biological and methodological variation of lymphocyte subsets in blood of human adults. J Immunol Methods 2007;322:20–7.10.1016/j.jim.2007.01.021Search in Google Scholar PubMed

32. German Reference Institute for Bioanalytics Surveys Immunphenotyping (flow cytometry) 2018. Available at: https://www.rfb.bio/cgi/results?rv_type=IS&rvTypeForDetails=IS&year=2018&rv_num=1&analyte=all&searchType=rv_type. Accessed: 24 Jul 2018.Search in Google Scholar