혈청단백 전기영동 및 면역고정 전기영동 검사의 국내 외부정도관리 평가
External Quality Assessment of Serum Protein and Immunofixation Electrophoresis in Korea
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초록
국내의 많은 검사실에서 혈청단백 전기영동과 면역고정 전기영동의 외부 정도관리를 검사실 간 숙련도 평가에 의존하고 있다. 이에 본 연구에서는 국내 12곳의 임상검사실을 대상으로 외부 정도관리 평가를 시행하였다. 본원 검사실의 잔여 검체 중 전기영동 패턴 혹은 단클론성 단백의 유무에 따라 혼합하여 5개의 시험용 검체를 제조하였고 이를 소분하였다. 각 검사실에서 검사를 시행하였고 각 검사실의 방식에 따라 판독 보고서를 작성하였다. 5개의검체 중 2개에서 단클론성 단백이 검출되었고, 단클론성 단백의검출 여부 및 개별형에 대해서는 모든 참가 기관 간에 결과가 일치하였다. 알부민, 알파-1, 2 글로불린, 베타-감마 영역의 정량 값에는별 차이가 없었으나, 베타-1, 2, 감마 글로불린 영역의 정량 값은 기관별로 큰 차이를 보였다. 접선절삭법을 사용하는 경우 다른 방법에 비해 이상단백의 정량 값이 가장 작았다. 본 연구에서 판독 보고서는 기관 간에 대체적으로 일치하였으나, 정량 값은 다소 차이가 있었다. 본 연구는 국내에서 혈청단백 전기영동과 면역고정 전기영동의 외부 정도관리에 대한 첫 연구로서, 후속 연구들을 통해위 검사들에 대한 국내의 외부 정도관리 지침이 마련되어야 할 것이다.
Abstract
In Korea, many laboratories rely on inter-laboratory proficiency testing for external quality control of serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE). Therefore, we conducted an external quality assessment in 12 clinical laboratories. Five test samples were prepared by pooling residual samples together in our laboratory according to the SPEP pattern or the existence of monoclonal proteins, and then aliquoting them. Each clinical laboratory carried out SPEP and IFE tests, quantified each fraction and monoclonal protein (if present), and produced the interpretation reports according to the method of each laboratory. Monoclonal protein was detected in two of the five test samples, and the detection of monoclonal proteins and the isotyping results were consistent in all participating institutions. There were no significant variations in the quantities of albumin, alpha-1, and -2 globulin fractions, and the whole beta-gamma region. However, the values of beta-1, -2, and gamma globulin fractions differed significantly, and there was a large variation in the reported monoclonal protein concentrations. The quantitative values obtained using the tangent skimming method were much lower than those obtained using the other methods. In this study, the interpretation reports were generally consistent, but the quantitative values were different between the participating laboratories. This is the first study to approach the external quality assessment of SPEP and IFE in Korea. Further studies are required to establish external quality control management for these tests.
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