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당화혈색소에 대한 정확도 기반 신빙도조사의 6년간 경험
Six Years’ Experience of Accuracy-Based Proficiency Testing for HbA1c in Korea
J Lab Med Qual Assur 2015;37:92-100
Published online June 30, 2015
© 2015 Korean Association of Quality Assurance for Clinical Laboratory.

정소이1,2 ? 전선희3 ? 송운흥4 ? 송정한1,3
Soie Chung1,2, Sun Hee Jun3, Woon Heung Song4, and Junghan Song1,3

1서울대학교 의과대학 검사의학교실, 2서울대학교병원 헬스케어시스템 강남센터 진단검사의학과, 3분당서울대학교병원 진단검사의학과, 4신한대학교 보건과학대학 임상병리학과

1Department of Laboratory Medicine, Seoul National University College of Medicine; 2Department of Laboratory Medicine, Seoul National University Hospital, Healthcare System Gangnam Center, Seoul; 3Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam; 4Department of Biomedical Laboratory Science, Shinhan University, Uijeongbu, Korea
Correspondence to: Junghan Song
Department of Laboratory Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro 173beon-gil, Bundanggu, Seongnam 463-707, Korea
Tel: +82-31-787-7691
Fax: +82-31-787-4015
E-mail: songjhcp@snu.ac.kr
Received March 25, 2015; Revised April 26, 2015; Accepted May 19, 2015.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
 Abstract
배경: 대한임상검사정도관리협회에서 주관하는 당화혈색소(HbA1c)의 신빙도조사사업은 2007년에 처음 시작하였고 2007년부터 2008년까지는 동일 장비군 내 평균을 기준으로 평가하는 방식으로 진행하다가 2009년부터 정확도에 근거한 외부정도관리(accuracy-based proficiency testing)를 시행하였다. 본 연구는 2009년부터 2014년 현재까지 신빙도조사의 결과를 분석하고자 하였다.
방법: 2009년부터 2014년 현재까지 당화혈색소 신빙도조사사업의 결과를 바탕으로 각 연도별 참여기관 수, 응답률, 허용범위를 벗어난 참여기관 수, 각 방법 코드별 참값으로부터의 바이어스와 변이계수 등을 분석하였다.
결과: 2009년 신빙도조사사업의 초기단계에서 참여기관의 수는 180개에 불과하였으나 차기 5년 동안 점차 그 수가 늘어 2014년 현재 345기관이 참여하고 있고, 응답률은 93.8-99.1% 정도였다. 2009년 신빙도조사사업 초기에 비해 측정방법의 변화가 있었고 현재는 대부분의 기관이 highperformance liquid chromatography (HPLC) 측정법을 사용하고 있다. HPLC법은 참값과의 바이어스와 검사실 간 변이계수가 적어(<3.5%) 양호한 성적을 보였다. 면역측정법과 point-of-care testing (POCT)법은 HPLC법에 비하면 검사실 간 변이계수가 크고 방법에 따라서는 참값과의 차이 목표 한계인 ±8%를 벗어나는 것이 있어 성능이 상대적으로 좋지 않았다.
결론: 2014년 현재 신빙도조사사업은 규모가 비교적 큰 검사실에서 참여하고 있다. 신빙도조사결과에 따르면 POCT법은 허용범위를 벗어난 비율이 가장 높고 정밀도가 좋지 않아 POCT법을 사용하는 소규모 검사실의 신빙도조사사업 참여를 독려하고 사업을 확대할 필요성이 있다.
(J Lab Med Qual Assur 2015;37:92-100)
Background: The proficiency testing (PT) program for HbA1c, performed by the Korean Association of External Quality Assessment Service (KAEQAS), first started in 2007. From 2007 to 2008, the results were assessed using means as the standard within a peer group (identical method group). However, the assessment method changed to accuracy-based PT in 2009. This study aimed to analyse the results of an external quality assessment of HbA1c from 2009 to 2014.
Methods: Based on the data obtained from the external quality assessment of HbA1c from 2009 to 2014, we analysed the number of participating institutions, response rate, ‘unacceptable’ result rate, bias from the target value, and CVs according to each instrument code.
Results: The number of participating institutions was only 180 in 2009. However, it increased over the next 5 years, and as of 2014, 345 institutions were enrolled. The response rates were 93.8% to 99.1%. Since 2009, the measurement method changed and most of the participating institutions now use the high-performance liquid chromatography (HPLC) method. As of 2014, the HPLC method showed small bias from the target value and inter-laboratory CVs (<3.5%), demonstrating satisfactory performance. Immunoassays and point-of-care testing (POCT) demonstrated relatively unsatisfactory performance, showing larger inter-laboratory CVs compared to those obtained with the HPLC method, with some of them exceeding the acceptance limit of ±8% of the target value.
Conclusions
: As of 2014, relatively large-scale laboratories are participating in the accuracybased PT for HbA1c. According to the accuracy-based PT for HbA1c, POCT showed the highest ‘unacceptable’ rate and imprecision. Therefore, small-scale laboratories mostly using POCT for HbA1c measurement should be encouraged to participate in the accuracybased PT program for HbA1c, and the external quality assessment program undertaken by KAEQAS should be expanded.
(J Lab Med Qual Assur 2015;37:92-100)
Keywords : Glycated hemoglobin, HbA1c, Laboratory proficiency testing
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