泰莱-Ⅱ型时间分辨荧光免疫分析仪检测肿瘤标记物的方法学评价

Methodology evaluation of determination of tumor markers using TALENT- Ⅱ time-resolved fluorescence immunoassay instrument

目的 对广州丰华公司泰莱（TALENT）-Ⅱ型时间分辨荧光免疫分析仪定量检测肿瘤标记物的方法学予以评价。方法 参照NCCLS EP10-T2文件，对泰莱Ⅱ型时间分辨荧光免疫分析仪检测人血清中的甲胎蛋白（hAFP）、癌胚抗原（CEA）进行评价，内容主要为线性、偏差、不精密度等指标。结果 高、中、低三种浓度CEA的绝对偏差分别是0．33、9．15、7．54ng／ml，低于允许偏差的2．15、32．16、107．46ng／ml；三种浓度hAFP的绝对偏差分别是6．06、57．02、66．81U／ml，低于允许偏差的6．54、107．73、247．98U／ml；三种浓度CEA的总不精密度分别是26．65％、3．30％和0．94％；hAFP的总不精密度分别是21.44％、0．86％和0．35％，除低浓度外均小于NCCLS文件规定的15％。与电化学发光法有良好的相关性，两个项目的相关系数分别为0．9993、0．9946。结论 TALENT-Ⅱ型时间分辨荧光免疫分析仪检测CEA和hAFP线性好，准确度高，精密度好，与电化学发光定量分析法高度相关，仪器稳定性好，性能可靠。

Objective To evaluate the methodology of TALENT-Ⅱ time-resolved fluorescence immunoassay instrument detecting tumor markers, Methods Tne determinations of hAFP and CEA in human serum were evaiuated including the linearity, the bias and the imprecision based on NCCLS EP10-T2. Results The absolute bias of three different concentration levels of CEA were lower than the allowable error,which were 0. 33,9. 15 and 7, 54 ng/ml vs. 2. 15,32. 16 and 107. 46 ng/ml. And that of hAFP were lower than the allowable error,which were 6.06,57, 02 and 66.81 U/ml vs. 6, 54, 107.73 and 247, 89 U/ml. The total imprecision of three concentration levels of CEA were 26. 65%, 3.30% and 0. 94%. And that of hAFP were 21.44% ,0.86% and 0.35%. All of the total imprecision were lower that 15 % based on NCCLS except that of low concentration level. The correlation coefficient was 0. 999 3 between time-resolved fluorescence immunoassay method and chemiluminescence immunoassay method for CEA and was 0. 994 6 for hAFP. Conclusion The determination of CEA and hAFP using TALENT- Ⅱ time-resolved fluorescence immunoassay instrument has good linearity,accuracy and precision. And there is close correlation between this method and chemiluminescence immunoassay method.