目的:参照美国国家实验室标准委员会(NCCLS)的EP9-A2文件,对测定血清中甲胎蛋白(AFP)含量的电化学发光免疫法和光激化学发光法进行方法学比对试验,比较二者结果的一致性.方法:收集40例患者血清标本,以罗氏Cobas601电化学发光免疫分析仪为比较仪器(x),博阳LICA光激化学发光免疫分析仪为实验仪器(y),同时检测血清中AFP的含量；分析2种生化仪测定结果之间的相关性和2种方法检测结果的一致性.结果:2种仪器测定的结果相关性良好(r=0.9925),预期偏倚可以接受.结论:在严格接操作规程进行检测的前提下,2种方法测定结果基本一致,其偏差可为临床所接受.当同一实验室同一检验项目存在2种以上检测方法时,应进行方法比对,判断其临床可接受性,以保证检验结果的可比性.%Objective: To compare the consistency of serum alpha fetoprotein(AFP) results determined by electrochemiluminescence immunoassay and light initiated chemiluminescence assay, referring to EP9-A2 files of NCCLS. Methods: To choose the electrochemiluminescence immunoassay as comparative method (x) and the light initiated chemiluminescence assay as experimental method (y). To analyze the correlativity and the consistency of the results determined by two methods in 40 clinical serum specimens. Results: The results of two groups were correlated (r=0.9925). The expected bias was in the range of acceptable bias. Conclusion: The bias between two methods can be clinically accepted on the premise of strict operation. If there are more than two methods for the same test used in a laboratory, method comparison and judgment of the clinical acceptivity are necessary in order to ensure the comparability of experimental results.
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