국내 29개 병원의 혈청단백 전기영동 및 면역고정 전기영동 검사현황 고찰 = Current Status of Serum Protein and Immunofixation Electrophoresis from 29 Hospitals in Korea

다국어 초록 (Multilingual Abstract)

Background: This study aimed to investigate the current status of serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE) in Korea.
Methods: Two structured questionnaires were developed using the Naver online platform and provided to clinical pathologists in charge of clinical chemistry. The first questionnaire consisted of 21 questions regarding the methods of testing, quantitation, and interpretation reports. A second questionnaire was administered on the name of the instrument and quality control.
Results: A total of 29 hospital clinical laboratories responded to our first survey, and among them, 15 hospitals participated in the second survey. Twenty-six (89.7%) laboratories reported both quantitative values and interpretation reports, and 24 (82.8%) laboratories presented the ratio of each globulin fraction along with the quantitative values. However, the reporting unit and decimal place, fractionation of each globulin, commentation, terminology, and quantitation method for a monoclonal protein varied among the participating laboratories. Seventeen (58.6%) laboratories performed the inter-laboratory proficiency test, and there were differences in the methods of internal and external quality control among the laboratories.
Conclusions: Variations in SPEP and IFE tests, including quantitation, interpretation reports, and quality control according to the laboratories, were observed. Although this study included a limited number of hospitals, it is the first to report the current status of SPEP and IFE in Korea. Harmonization of methods for reporting results and interpretation reports is needed to reduce the potential inconsistencies in the results.

국문 초록 (Abstract)

배경: 본 연구는 혈청단백 전기영동과 면역고정 전기영동의 국내 현황을 조사하는 연구이다.
방법: 임상화학 분야를 담당하는 국내 진단검사의학과 전문의들을 대상으로 네이버 웹 기반의 구조화된 설문조사를 2회에 걸쳐 진행하였다. 첫 번째 설문조사는 검사방법, 정량법, 판독 보고서와 관련된 21개 문항으로 구성되었고, 이어서 기기명 및 내 · 외부 정도관리에 대한 두 번째 설문조사가 시행되었다.
결과: 총 29개 병원이 1차 설문조사에, 그리고 그 중 15개 병원이 2차 설문조사까지 응답하였다. 26개(89.7%) 기관이 정량 값과 판독 보고서 모두를 보고하였고, 24개(82.8%) 기관이 각 글로불린 분획별 정량 값과 비율 모두를 제시하였다. 반면에 보고 단위 및 소수점 표기 단위, 각 글로불린 분획 방식, 추가적인 서술, 단클론성 단백에 대한 용어 및 정량법 등은 기관마다 상이하였다. 17개(58.6) 기관이 검사실 간 신빙도 평가를 시행하였으며, 내 · 외부 정도관리 방식은 기관별로 차이가 존재하였다.
결론: 각 기관마다 혈청단백 전기영동 및 면역고정 전기영동의 정량법, 판독 보고서, 정도관리 등의 방식이 다양함을 알 수 있었다. 비록 본 연구에 참여한 기관 수가 적다는 한계가 있지만, 본 연구는 혈청단백 전기영동 및 면역고정 전기영동의 국내 현황을 반영하는 최초의 연구이다. 결과 보고 및 해석 보고서 방식의 일치화를 통해 검사 결과의 불일치를 감소시키는 노력이 필요할 것이다.

참고문헌 (Reference)

1 O’Connell TX, "Understanding and interpreting the serum protein electrophoresis" 71 : 105-112, 2005

2 Kyle RA, "The monoclonal gammopathies" 40 : 2154-2161, 1994

3 McCudden CR, "Synoptic reporting for protein electrophoresis and immunofixation" 51 : 21-28, 2018

4 Vavricka SR, "Serum protein electrophoresis : an underused but very useful test" 79 : 203-210, 2009

5 Wijeratne N, "Report of the survey conducted by RCPAQAP on current practice for paraprotein and serum free light chain measurement and reporting : a need for harmonisation" 40 : 31-42, 2019

6 Schild C, "Reliability of M protein quantification : comparison of two peak integration methods on Capillarys 2" 46 : 876-877, 2008

7 Tate J, "Recommendations for standardized reporting of protein electrophoresis in Australia and New Zealand" 49 : 242-256, 2012

8 Keren DF, "Protein electrophoresis in clinical diagnosis" Hodder Arnold 2012

9 Tate JR, "Proposed addendum to 2012 recommendations for standardised reporting of protein electrophoresis in Australia and New Zealand" 40 : 23-30, 2019

10 Willrich MAV, "Performance of perpendicular drop versus tangent skimming gating of M-protein in proficiency testing challenges" 59 : e19-e22, 2020

11 McCudden CR, "Performance comparison of capillary and agarose gel electrophoresis for the identification and characterization of monoclonal immunoglobulins" 129 : 451-458, 2008

12 Regeniter A, "Peaks and tails : Evaluation of irregularities in capillary serum protein electrophoresis" 51 : 48-55, 2018

13 Chan PC, "On the path to evidence-based reporting of serum protein electrophoresis patterns in the absence of a discernible monoclonal protein-A critical review of literature and practice suggestions" 51 : 29-37, 2018

14 Clavijo A, "Measurement of monoclonal immunoglobulin protein concentration in serum protein electrophoresis : comparison of automated vs manual/human readings" 51 : 252-258, 2020

15 Bender LM, "Evaluation of digital images for identification and characterization of monoclonal immunoglobulins by immunofixation" 46 : 255-258, 2013

16 Azim W, "Diagnostic significance of serum protein electrophoresis" 20 : 40-44, 2004

17 Keren DF, "Challenges of measuring monoclonal proteins in serum" 54 : 947-961, 2016

18 Booth RA, "Candidate recommendations for protein electrophoresis reporting from the Canadian Society of Clinical Chemists Mono-clonal Gammopathy Working Group" 51 : 10-20, 2018

19 Jacobs JFM, "An international multi-center serum protein electrophoresis accuracy and M-protein isotyping study. Part II : limit of detection and follow-up of patients with small M-proteins" 58 : 547-559, 2020