국내 임상검사실의 검사법 평가절차 현황 고찰
Current Status of Method Evaluation Procedures Used by Clinical Laboratories in Korea
2
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
배경: 본 연구는 검사법 평가에 대한 국내 현황을 조사하는 연구이다. 방법: 국내 진단검사의학과 전문의들을 대상으로 설문조사를 시행하였으며, 설문의 내용은 먼저 기관의 기본 정보를 조사하였고, 검사법 평가에 대해서는 정밀도, 직선성, 방법 간 비교, 기타 등 총 4개 파트 32문항으로 구성하였다. 결과: 총 60개 기관에서 설문에 응답하였다. 검사법 평가에 사용하는 통계 프로그램은 기관별, 항목별로 다양하였다. 정밀도에 대해서는 5×5 프로토콜을 주로 사용하였고, 평가 기준은 제조사 제시 변이계수가 가장 많았다. 직선성에 대해서는 회수율을 바탕으로 평가하는 경우가 가장 많았고, 제조사에서 제시하는 희석배수를 별도의 검정 없이 사용하는 기관이 절반 이상이었다. 방법 간 비교는 주로 40개 검체로 시행하여 최소제곱 선형회귀 혹은 Passing-Bablok 회귀분석으로 분석하는 경우가 가장 많았고, 평행 검사의 판정 기준으로는 임계 차이를 이용하는 경우가 적었다. 측정능, 잔효, 참고구간, 정성검사 성능평가에 있어서도 기관마다 상이하였다. 결론: 각 기관마다 검사법 평가에 대한 지침과 시행 현황이 다양함을 알 수 있었다. 본 연구는 검사법 평가에 대한 국내 현황을 반영하는 최초의 연구이다. 후속 연구를 통해 검사법 평가에 대한 표준화된 국내 지침을 제공하고, 지속적인 교육 및 관리를 통해 검사실의 질 향상을 위한 노력이 이루어져야 할 것이다.
Abstract
Background: The aim of this study was to investigate the current status of method evaluation in Korea. Methods: A questionnaire was provided to domestic medical laboratory professionals to survey the method evaluation practices of their institutions. The survey consisted of 32 questions divided into four parts: precision, linearity, method comparison, and others. Results: In total, 60 institutions responded to this questionnaire survey. According to the responses, the statistical programs used for method evaluation varied among the institutions and test items. The 5×5 protocol was mainly used for precision testing, with the manufacturer’s claim being the main acceptance criterion. Linearity was most often evaluated on the basis of the recovery rate, and more than half of the institutions directly used the dilution factor provided by the manufacturer without verifying it. Method comparison was mainly conducted with 40 samples, and the results were analyzed using the least squares linear regression or Passing–Bablok regression analysis methods. The respondents indicated a low use of critical difference as a criterion for judging parallel tests. The institutions varied greatly in detection capabilities, carryover, reference interval, and qualitative testing. Conclusions: Among the laboratories, variations in method evaluation protocols and the current status were observed. This is the first study to elucidate the current status of method comparison in medical laboratories. Further studies as well as continuous education and management are needed to provide standardized domestic guidelines for method evaluation and to improve the quality of laboratories.
참고문헌 (27)
- Loh TP, "Method evaluation in the clinical laboratory", Clin Chem Lab Med, 61, pp.751~758 (2022)
- Topic E, "How to assess the quality of your analytical method?", Clin Chem Lab Med, 53, pp.1707~1718 (2015)
- Woollard G, "Total pathway to method validation", Clin Chem Lab Med, 58, pp.e257~e261 (2020)
- Theodorsson E, "Validation and verification of measurement methods in clinical chemistry", Bioanalysis, 4, pp.305~320 (2012)
- Milevoj Kopčinović L, "Verification policies in Croatian medical biochemistry laboratories : a survey of the practice", Biochem Med(Zagreb), 32, pp.020703~ (2022)
- Hand M, "A survey of clinical laboratory instrument verification in the UK and New Zealand", Ann Clin Biochem, 56, pp.275~282 (2019)
- Laboratory Medicine Foundation, "Accreditation checklists-Basic B 400.010", ~ (2024)
- Clinical, Laboratory Standard Institute, "User verification of precision and estimation of bias; Approved guideline-" (2014), Clinical and Laboratory Standards Institute
- Clinical, Laboratory Standard Institute, "Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-" (2014), Clinical and Laboratory Standards Institute
- Clinical, Laboratory Standard Institute, "Evaluation of Linearity of Quantitative Measurement Procedures" (2020), Clinical and Laboratory Standards Institute
- Clinical, Laboratory Standard Institute, "Evaluation of the linearity of quantitative measurement procedures: A statistical approach; Approved guideline" (2003), Clinical and Laboratory Standards Institute
- Clinical, Laboratory Standard Institute, "Establishing and verifying an extended measuring interval through specimen dilution and spiking" (2018), Clinical and Laboratory Standards Institute
- Clinical, Laboratory Standard Institute, "User evaluation of between-reagent lot variation; Approved guideline" (2013), Clinical and Laboratory Standards Institute
- Clinical, Laboratory Standard Institute, "Verification of comparability of patient results within one health care system; Approved guideline" (2008), Clinical and Laboratory Standards Institute
- Clinical, Laboratory Standard Institute, "Verification of comparability of patient results within one health care system; Approved guideline (interim revision)" (2012), Clinical and Laboratory Standards Institute
- Plebani M, "A manifesto for the future of laboratory medicine professionals", Clin Chim Acta, 489, pp.49~52 (2019)
- Greaves RF, "Key questions about the future of laboratory medicine in the next decade of the 21st century : a report from the IFCC-Emerging Technologies Division", Clin Chim Acta, 495, pp.570~589 (2019)
- Haeckel R, "Validation of quantitative analytical procedures in laboratory medicine", J Lab Med, 36, pp.111~118 (2012)
- Clinical, Laboratory Standard Institute, "A framework for using CLSI documents to evaluate clinical laboratory measurement procedures" (2015), Clinical and Laboratory Standard Institute
- "International vocabulary of metrology - Basic and general concepts and associated terms (VIM). Joint Committee for Guides in Metrology, JCGM 200:2012, 3rd edition" (2012)[URL]
- The International Organization for Standardization, "Medical laboratories - Requirements for quality and competence. ISO 15189;2022", International Standard Organization, ~ (2022)
- Roelofsen-de Beer R, "Validation and verification of examination procedures in medical laboratories : opinion of the EFLM Working Group Accreditation and ISO", CEN standards(WG-A, Clin Chem Lab Med, pp.2020, 58[DOI]
- Korean Society for Laboratory Medicine, "Laboratory Medicine" (2021), Panmun Education
- Korean Society for Laboratory Medicine, "Practical Handbook of Laboratory Medicine" (2021), Panmun Education
- Clinical, Laboratory Standard Institute, "Measurement procedure comparison and bias estimation using patient samples" (2018), Clinical and Laboratory Standards Institute
- Clinical, Laboratory Standard Institute, "Defining, establishing, and verifying reference intervals in the clinical laboratory; Approved guideline-" (2010), Clinical and Laboratory Standards Institute
- Clinical, Laboratory Standard Institute, "User protocol for evaluation of qualitative test performance; Approved guideline-" (2008), Clinical and Laboratory Standards Institute