化学发光免疫分析法和时间分辨免疫荧光法定量检测不同浓度HBsAg的对比分析

目的以雅培全自动化学发光免疫分析法(CMIA法)为标准,探讨时间分辨免疫荧光法(TRIFA)检测血清乙型肝炎表面抗原(HBsAg)的准确性和可行性,以便基层医院普遍开展此项目,为抗病毒个体化的策略及疗效的预测提供依据。方法分别用CMIA法和TRIFA法对157份乙型肝炎病毒(HBV)感染患者的血清进行检测,对于HBsAg滴度超过检测上限的样本,采用稀释液手动稀释后,再进行定量分析。将HBsAg水平分为4组:≤100 IU/mL、101~1 000 IU/mL、1 001~20 000 IU/mL、20 000 IU/mL,分析两种方法阳性标本定量相关性。结果两种方法的直线回归方程为:Y=2.323X-896.3,相关系数r=0.943,P0.001。以CMIA法检测值为参考,分为4组进行分析,结果显示在检测低浓度HBsAg样本时,TRIFA数值较CMIA法偏低,而高浓度样本以CMIA法检测值偏高。两种试剂在检测不同浓度的HBsAg均有较好的一致性(均P0.05),其中以浓度在1 001~20 000 IU/mL时相关性最好。结论两种试剂在HBsAg定量检测上的准确性基本相当,定量相关性以检测值在1 001~20 000 IU/mL之间最佳。TRIFA成本低廉、易操作,更适于基层医院使用,具有广泛的应用前景。

Quantitative detection on different HBsAg levels by chemiluminescence immunoassay and time resolved immunofluorescence assay

ObjectiveTo evaluate the accuracy and feasibility of time resolved immunofluorometric assay (TRIFA) for detection of HBsAg based on Abbott automated chemiluminescence immunoassay(CMIA), so as to carry out this project in primary hospitals, and provide reference for individual antiviral strategy and prediction of therapeutic effect. MethodsSerum of 157 patients infected with hepatitis B virus were detected with CMIA and TRIFA, specimens with HBsAg titers exceeding the detection limit were firstly diluted, then performed quantitative analysis. HBsAg levels were divided into 4 groups: ≤100 IU/mL, 101-1 000 IU/mL, 1 001-20 000 IU/mL, and ＞20 000 IU/mL， quantitative correlation between two methods was analyzed. ResultsThe linear regression equation of two methods was Y=2.323X-896.3, correlation coefficent r=0.943, P<0.001. CMIA was as a reference, 4 groups were divided for analysis, results showed that when detected specimens was at low concentration of HBsAg, TRIFA value was low compared with CMIA method, while detected specimens was at high concentration of HBsAg, CMIA value was high, two reagents had good consistency in the detection of different concentrations of HBsAg(both P<0.05), when concentration was at 1 001-20 000 IU/mL, consistency was the best. ConclusionThe accuracy of two reagents in the quantitative detection of HBsAg is similar, and the best correlation of detection value is 1 000-20 000 IU/mL. TRIFA assay has wide application for its low cost and easy to be operated, which is especially suitable for primary hospitals.