用患者样本进行电解质分析仪比对试验

目的:为了使同一临床实验室不同的电解质分析仪测定结果具有可比性。方法:按照EP9- A文件要求,用准确性和重复性都最佳的全自动生化仪Beckman L x- 2 0 (用A表示)作为参考仪器,用患者标本作为样本,对其他两台电解质分析仪深圳航创9886、DH5 0 5 (分别用B、C表示)进行相关性评估和偏差评估,对不符合要求的仪器进行校正。结果:B、C两仪器的K+ 、Na+ 、Cl- 测定结果与A仪器比较相关性都较好(r均>0 .975 )。B仪器的各项测定结果预期偏差和相对偏差均在美国CL IA88要求的临床允许误差之内,无需校正。C仪器K+、Na+测定相对偏差较大,有的超过了美国CL IA88要求的临床允许误差,用病人新鲜血清以Beckman L x- 2 0为参比仪器进行校正后,使其相对偏差缩小至美国CL IA88要求的临床允许误差范围内。结论:利用患者样本进行比对试验和偏差评估,并进行校正,可提高同一临床实验室不同电解质分析仪测定结果间的可比性。

Laboratory Analyzers be Corrected After Method Comparison with Serum Samples of Patients

Objective Inorder to improve the comparison of the results determined by different electrolytic analyzer in the same laboratory.Methods According to the profile NCCLS-EP9-A,Beckman Lx-20(A) with the best reproducibility and accuracy worked as a comparative one .H-9886 (B)and DH505(C) worked as laboratory ones. Fresh serum samples of patients were analyzed by the three analyers to obtain the correlation coefficient and evaluate the outcome bias between comparative one and laboratory one.Then we corrected the analyzer with unacceptable outcome biases.Results There were good relativity of the results of K+?Na+?Cl-between B and A,so do C and A(r>0.975). The deviation and outcome biases of the results of B were acceptable according to the allowable error of CLIA88. It is not necessary to correct B.The deviation and outcome biases of K+?Na+?Cl- of C were not acceptable.Some of the results were even over the allowable error of CLIA88. After correcting C with fresh serum samples of patients we made the deviation within the allowable error of CLIA88.Conclusions Laboratory analyzers should be corrected after method comparison and bias estimation were employed with serum samples of patients.Thus,comparison among various analyzers were improved.