酶联免疫吸附试验和微粒子酶免疫分析法检测血清甲型肝炎总抗体的比较研究

Comparison on Two Methods of ELISA and MEIA in Detecting Total AntiHAV Antibody

目的评估酶联免疫吸附试验(ELISA)和微粒子酶免疫分析法(MEIA)检测血清甲型肝炎(甲肝)总抗体的检测性能,从而说明两种方法在各自实际应用中的区别。方法用ELISA和MEIA法检测血清甲肝总抗体,再进行两种方法的互相比较。结果检测同一批血清甲肝总抗体样品,定量检测时ELISA法试剂盒敏感度为57.57毫国际单位/毫升(mIU/ml),变异系数(C V)为10.65%,其结果比MEIA法高;两种方法抗体几何平均浓度(GMC)分别为125.8mIU/ml、58.8mIU/ml;定性检测时,41例标本中ELISA法检测39例阳性,MEIA法40例阳性,两法的符合率为97.56%(40/41)。结论定量检测时,MEIA法比ELISA法更精确;定性检测时,ELISA法试剂盒能客观反映疫苗的免疫原性和保护效果,与MEIA法结合能大大提高敏感性。

Objective To compare the performance of ELISA and MEIA methods used in detecting of total anti-HAV antibody, and to illustrate their differences application. Methods ELISA and MEIA methods were used to detect total anti-HAV antibody, and compare their sensitivity and accordance. Result Quantitative detection of total anti-HAV antibody, the sensitivity of ELISA was 57.57mIU/mL, the coefficient of variation （CV）was 10. 65%, its value was higher than MEIA method,the GMT of the two methods were 125.8mIU/mL and 58.8mIU/mL respectively; when qualitative detection,positive cases of ELISA and MEIA methods were 39 cases vs 40 cases, then two methods＇ coincidence rates are 97.56% （40/41）. Conclusion In quantitative detection, MEIA method was more precise than ELISA method. In qualitative detection, the ELISA method can objectively reflect the immunogenicity and the protection efficacy of HAV vaccine, as combined to MEIA method its sensitivity can be greatly enhanced.