CAJ | 학술논문

目的：改进 EP9-A2指南使之可用于全线性范围内多个定量检测系统间的偏倚评估。方法在4套检测系统（A、B、C、D）上检测40份患者标本的血清总胆固醇浓度，以 A 系统为参考系统，按 EP9-A2指南评估 B、C、D 系统的偏倚；在此基础上，计算两两系统间偏倚可接受距离 DD（偏倚与分析质量目标之间的距离），以置信区间包含0为标准来识别系统间不可接受的偏倚。结果与 A 系统相比，B、C 两系统呈负向偏倚，D 系统呈正向偏倚，但 B、C、D 与 A 系统的偏倚均可接受；各系统间 DD 呈正态分布；除DD BD 置信区间包含0，B、D 两系统间偏倚不可接受外，其余系统间偏倚均可被接受；将 D 系统结果经 A 系统校正后，各系统间偏倚均可接受；作图可提供全线性范围内的偏倚评估。结论DD 均值的置信区间，可在全线性范围内有效评估3个或更多系统间的偏倚，可用于评估系统间的结果可比性。
목적：개진 EP9-A2지남사지가용우전선성범위내다개정량검측계통간적편의평고。방법재4투검측계통（A、B、C、D）상검측40빈환자표본적혈청총담고순농도，이 A 계통위삼고계통，안 EP9-A2지남평고 B、C、D 계통적편의；재차기출상，계산량량계통간편의가접수거리 DD（편의여분석질량목표지간적거리），이치신구간포함0위표준래식별계통간불가접수적편의。결과여 A 계통상비，B、C 량계통정부향편의，D 계통정정향편의，단 B、C、D 여 A 계통적편의균가접수；각계통간 DD 정정태분포；제DD BD 치신구간포함0，B、D 량계통간편의불가접수외，기여계통간편의균가피접수；장 D 계통결과경 A 계통교정후，각계통간편의균가접수；작도가제공전선성범위내적편의평고。결론DD 균치적치신구간，가재전선성범위내유효평고3개혹경다계통간적편의，가용우평고계통간적결과가비성。
Objective To improve EP9-A2 for Bias estimation among multiple quantitative detection systems within full range of AMR.Methods 40 patients specimens were determined twice for serum total cholesterol by four detection systems(A,B,C and D).With system A served as comparative method,Bias between A and the other three was evaluated according to CLSI EP9-A2 separately.Furthermore,DD(distance from deviation to tolerable error)and its average confidence intervals between every two sys-tem were calculated and compared with zero.The confidence interval of greater than zero was served as criteria for accepting bias between every two system.Results Bias between A and the other three meet the analytical quality specification according to EP9-A2,although that of D system was positive,and those of B and C system were negative.DD between every two system obeyed nor-mality distribution.All biases between every two system wes acceptable except that between B and D,causing of their interval con-taining zero.After correcting of results from system D,Biases between every two system were all acceptable.Plots of confidence in-terval could provide a full range bias assessment within AMR.Conclusion Comparability and Bias estimation in full range of AMR for results between every two system among 3 or more systems could be evaluated by confidence intervals.