Improvement of EP9-A2 for bias estimation among multiple quantitative detection systems in full range of AMR / 国际检验医学杂志

ABSTRACT

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.