不同电化学发光免疫分析仪测定结果的可比性分析

目的：探讨罗氏E601和E411两系统间相同项目的检测结果是否具有可比性，以确保不同仪器在检测相同项目时检测结果的准确性和一致性。方法按照美国临床实验室标准化委员会（NCCLS）EP9-A2文件要求，以E601电化学发光免疫分析仪为比对仪器，E411为实验仪器，促甲状腺激素（TSH）为比对项目进行比对分析。以美国临床实验室修正法规（CLIA′88）规定的室间质量评价允许误差范围的1/2TEa为标准，对两系统间的预期偏倚进行评估。结果两检测系统在医学决定水平处的预期偏倚在允许范围内，临床可以接受。结论临床实验室内同一检测项目同时在两套或以上系统检测时应进行比对和偏倚评估，以确保检测结果具有可比性。

Compare the results from different electro-chemiluminescence immunoassay analyzer

Objective To ensure the accuracy and consistency of Roche E 601 and E 411 in detection of TSH. Methods The val- ue of TSH of patient＇s serum was detected by Roche E411 （experimental method） andwas compared with Roche E601 （control method） according to the American Committee for clinical laboratory standards （NCCLS） approved EP9-A2. Using revised regula tions to American Clinical Laboratory （CLIA ＇88） provisions of the EQA allowable error range of 1/2TEa as the standard, the com- parability and bias of the two systems were evaluated. Results Two detection systems in the expected bias at medical decision level are within the allowable range and clinical acceptable. Conclusion It is necessary to analyze the bias of the results by two or more than two systems in clinical laboratory,which can insure the comparability.