两种方法检测促甲状腺受体抗体的比对研究

Comparison of Two Methods for Detection of Thyroid Receptor Antibodies

目的探讨不同免疫分析系统检测促甲状腺受体抗体(TRAb)结果的可比性,以评估国产新产业化学发光法检测TRAb能否满足临床需求。方法分别用新产业化学发光免疫分析(CLIA)仪和罗氏电化学发光免疫分析(ECLIA)仪测定TRAb,依据美国国家临床实验室标准化协会(NCCLS)EP9-A2文件,将ECLIA法作为参比方法,以CA法为试验方法,进行方法学比对试验。并应用Bland-Aman分析法评估其一致性。结果定性判断CLIA法检测假阳性率、假阴性率和总符合率分别为0、11.8%和95%,Kappa值为0.896;两种方法定量检测TRAb结果差异无统计学意义,P=0.55,并在0~30IU/L具有较好的线性相关性,其相关系数r=0.98,Passing-Bablock回归方程为Y=-0.04+1.06X,截距A的系统差异95%CI为-0.16~0.09,斜率B的比例差异95%CI为0.97~1.12,线性度无明显偏差(P=0.38),且BlandAman差异图显示,配对数据差值的平均值为-0.3IU/L,95%一致性界限为-3.9IU/L、4.5IU/L,在临床上可以接受。结论国产新产业化学发光免疫分析(CLIA)仪TRAb检测结果可以满足临床需求。

Objective To investigate the comparability of the results of different immune system analyses to detect thyroid stimulating hormone receptor antibody （TRAb）, so to evaluate whether the domestic New Industrial Chemistry Luminous Immunoassay can meet the clinical needs of TRAb test. Methods The TRAb was measured by the New Industrial Chemiluminescence Immunoassay （CLIA） and the Roche Electrochemiluminescence Immunoassay （ECLIA）. According to the National Laboratory for Clinical Laboratory Accreditation （NCCLS） EP9-A2, the ECLIA method was used as the reference method, and the CLIA method was used as the experimental method. And their identicalness was assessed by Bland-Altman analysis. Results Qualitative judgment of CLIA method to detect false positive rate, false negative rate and the total compliance rate were 0,11.8 % and 95 %, kappa value is 0. 896 ; there was no significant difference between the two methods in quantitative detection of TRAb, P = 0.55, And they had a good linear correlation at 0-30IU/L, the correlation coefficient r = 0.98. Passing-Bablock regression equation is Y = -0.04 ＋ 1.06 X, with the systematic difference of intercept A 95% CI was -0.16 -0.09, the ratio of slope B 95% CI was 0.97 - 1. 12. The linearity had no obvious deviation （ P = 0.38 ）. And the Bland-Altman difference graph shows that the mean of the pairing data difference is - 0.3IU / L and the 95% consensus limit is -3.9IU/L, 4.5IU / L, which is clinically acceptable. Conclusion The results of TRAb detection of the domestic New Industrial Chemistry Luminous Immunoassay can meet the clinical demand.