目的探讨不同化学发光检测系统测定甲胎蛋白(AFP)和癌胚抗原(CEA)结果的可比性，为本实验室不同检测系统检验结果的一致性提供依据。方法分别在西门子ADVIACentaurXP和国产北京滨松BHP9504两种化学发光免疫分析系统测定AFP和CEA，依据美国临床实验室标准化协会(CLSI)EP9-A2文件的规定，以西门子ADVIACentaurXP为比较方法，以国产北京滨松BHP9504为实验方法，进行方法学比对试验。结果两种系统各项结果间均呈良好的线性关系，其相关系数r均大于0.99，预期偏倚和相对偏倚均小于可接受限。结论两种化学发光免疫分析系统比对结果可以被临床接受。
Objective To explore the comparability of alpha fetoprotein (AFP) and carcinoembryonic antigen (CEA) detection results and provide basis for result concordance in different chemiluminescence immunoassay systems. Methods Referring to the document of NCCLS EP9-A2, the testing Results derived from two analysis systems were analyzed comparatively and their biases was evaluated by analysis in SIEMENS ADVIA Centaur XP as a control method and analysis in BHP9504 as experimental method. Results The testing results of AFP and CEA by two different systems were linear correlation (r>0.99). Their anticipated biases were within accepted biases. Conclusion The test results of AFP and CEA by two different systems could be accepted by clinic.
[1] National Committee for Clinical Laboratory Standants.EP9-A2:Method Comparison and Bias Estimation Using Patient Samples, Approved Guideline [M].2nd.Wayne:NCCLS,2002.
[2] 丛玉隆,冯仁丰,陈晓东.临床实验管理学[M].北京:中国医药科技出版社,2004:111-114.
[3] 陈曲波,庄俊华,张秀明,等.不同检测系统间甲状腺激素测定结果的偏倚分析及其可比性研究[J].中华内分泌代谢杂志,2006,22(3):288-289.
[4] 李胜发,徐华建,张莉萍,等.多个血细胞分析系统结果准确性和可比性的方法保证分析[J].重庆医学,2009,38(19): 2416.
[5] 魏昊,丛玉隆.医学实验室质量管理与认可指南[M].北京:中国计量出版社,2004:72- 75.
