Sigma Metrics를 이용한 자동화학분석기의 성능 평가
Evaluating the Performance of an Automated Chemistry Analyzer Using Sigma Metrics
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배경: 정도관리는 임상검사실에서 정확하고 신뢰성 있는 검사결 과를 얻기 위해서 중요하게 시행되고 있다. 이번 연구는 Westgard 가 제안한 sigma metrics를 이용하여 자동화학분석기의 검사항목 별로 sigma value를 계산하여 개별 내부정도관리 물질의 개수 및 rule의 기준을 설정해보았다. 방법: 자동화학분석기에서 검사하는 37개 항목을 대상으로, 6개 월 기간 동안 하루에 두 번씩, 동시에 두 가지 다른 농도의 내부정 도관리 물질을 측정한 데이터를 분석하였다. 총 허용오차, 바이어 스%, 변이계수를 통해 sigma value를 계산하였고, 값에 따라서 Westgard rule을 개별 적용하였다. 결과: 계산된 sigma value가 6보다 큰 검사항목은 haptoglobin, ALP, AST High level, ALT, amylase, direct & total bilirubin, CK, Fe, Mg High level, GGT, lipase, LD, HDL-cholesterol High level, protein High level, TG, TIBC High level, ferritin High level, uric acid 이었고, 그중에서 direct bilirubin이 가장 큰 sigma value를 보였다. 5-6 sigma value를 보인 항목은 IgA, RF High level, protein Low level, TIBC Low level이었고, 3-5 sigma value를 보인 항목은 RF Low level, AST Low level, creatinine, Cl, K, Na, Mg Low level, glucose, HDL-cholesterol Low level, ferritin Low level이었으며 Ca, LDL-cholesterol, total cholesterol, BUN, total CO2는 sigma value 가 Low level, 2 모두에서 3보다 작은 값을 보였다. Low level, 2중에 서 하나라도 3보다 작은 sigma value값을 보인 검사항목은 C4, IgM, IgG, albumin, Pi였다. 결론: 임상검사실에서 sigma metrics는 검사항목별로 다른 Westgard rule 채택의 근거이자 효율적인 정도관리 및 운영을 위해 활 용해야만 한다. 또한 sigma value가 3 미만을 보인 항목에 대해서 는 검사프로세스에 대한 점검이 즉각적으로 필요하다
Abstract
Background: Quality control (QC) is important for producing reliable test results in the clinical laboratory. Sigma metrics is used to evaluate the performance of laboratory instruments. It calculates the sigma value and determines the number of quality control material and strategy for the internal QC of the laboratory according to the sigma value. Methods: This study was conducted in the clinical laboratory of Korea University Anam Hospital for 6 months. We evaluated internal quality control data of 37 analytes on the automated chemistry analyzer. By Sigma metrics, we calculated the sigma value by (TEa-bias%)/coefficient of variance. Results: The analytes that exceeded the 6 sigma value were haptoglobin, ALP, AST High level, ALT, amylase, direct & total bilirubin, CK, Fe, Mg High level, GGT, lipase, LD, HDL-cholesterol High level, protein High level, triglyceride, TIBC High level, ferritin High level, and uric acid. IgA, RF High level, protein Low level, and TIBC Low level showed 5–6 Sigma values. RF Low level, AST Low level, creatinine, Cl, K, Na, Mg Low level, glucose, HDL-cholesterol Low level, and ferritin Low level showed 3–5 sigma values. Sigma values below 3 at both Low and High level QC materials were Ca, LDL-cholesterol, total cholesterol, BUN, and total CO2. Conclusions: In clinical laboratories, sigma metrics should be used as a basis for adopting different Westgard rules for each test and for efficient quality control operations. Also, in the case of analytes with sigma values below 3, improvement in the overall test process is needed.
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