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pISSN 2950-9114 eISSN 2950-9122
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Original Article

Lab Med Qual Assur 2024; 46(1): 43-54

Published online March 31, 2024


Copyright © Korean Association of External Quality Assessment Service.

External Quality Assessment and Clinical Laboratory Guidelines for Serum Protein and Immunofixation Electrophoresis in Korea

Jooyoung Cho1 , Dong Hyun Lee1 , Jisu Jeon1 , John Hoon Rim2 , Jong-Han Lee1 , and Juwon Kim1

1Department of Laboratory Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju; 2Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea

Correspondence to:Jooyoung Cho
Department of Laboratory Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju 26426, Korea
Tel +82-33-741-1595
E-mail purelove0927@yonsei.ac.kr

Received: October 27, 2023; Revised: November 27, 2023; Accepted: November 28, 2023

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.


Background: This study implemented an external quality assessment (EQA) of serum protein electrophoresis (SPEP) and immunofixation electrophoresis/immunotyping (IFE/IT) tests and aimed to present domestic guidelines regarding the interpretation report.
Methods: We conducted the EQA of SPEP and IFE/IT tests similar to the proficiency testing (PT) program of the Korean Association of External Quality Assessment (KEQAS). We prepared four test samples by pooling residual serum specimens, according to the SPEP pattern, and the existence and isotype of monoclonal proteins. Each test sample was aliquoted and sent to 29 clinical laboratories, each laboratory conducted SPEP and IFE/IT tests and returned quantitative values and interpretation reports.
Results: Variations in the quantitative values (g/dL) of each fraction and ratios (%) of each fraction to total protein were observed. The differences between the electrophoresis methods or manufacturers were not statistically significant. Of the four EQA samples, two samples had a monoclonal protein, and the presence and absence of monoclonal protein and isotypes were consistent in all participating institutions. However, there were statistically significant differences in the numerical values and ratios of monoclonal proteins between institutions.
Conclusions: This study examined the possibility of SPEP and IFE/IT tests being included in the PT program of the KEQAS, and we identified what should be supplemented for future assessments. Furthermore, we have presented the guidelines regarding SPEP and IFE/IT tests in Korea for the first time, and further studies are required to establish the EQA programs and standardized guidelines.

Keywords: Serum protein electrophoresis, Immunofixation electrophoresis, Immunotyping, External quality assessment, Proficiency testing program, Korean Association of External Quality Assessment

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