一种简便直接半定量检测抗HEV-IgG的方法及其临床观察

A simple semi-quantitative direct method for the measurement of HEV-IgG antibody

目的:改良抗HEV-IgG检测方法,并采用ELISA直接法半定量检测抗HEV-IgG滴度。方法:采用ELISA法结合标准曲线拟合计算抗HEV-IgG滴度,并与传统ELISA检验结果进行比较,如结果与传统ELISA不符,则采用检测HEV-RNA法(RT-PCR)进行验证。结果:改良抗HEV-IgG检测法与传统ELISA法相比,结果差异无统计学意义(P>0.05),且变异系数(CV)大大减小(P<0.05),批内、批间CV在3.7%～5.7%间,优于传统法(CV10.2%～20.0%)。改良法直接检测抗HEV-IgG线性可达1∶69.9,且无需样品稀释,对HEV近期感染的检测灵敏度提高至77.8%。结论:改良抗HEV-IgG检测方法简单、实用,精密度和准确度较好,适用于一般实验室操作,可作为常规方法推广。

Objective To measure semi-quantitatively the HEV-IgG antibody using a modified direct ELISA assay. Methods HEV-IgG antibody titer was measured by ELISA matched against an established standard curve. The test results with traditional ELISA and intrabatch and interbatch coefficient of variation （CV） were analyzed. If the result did not match with the result of traditional ELISA, RT-PCR was used for validation. Results No significant difference was found between the test results of this modified method and the traditional method. CV of this method was significantly lower than that of the traditional method. The intrabatch and interbatch CV of these two methods were 3.7%-5.7% and 10.2%-20.0%, respectively. The linear range of this modified method could be up to 1：69.9, and no dilution of sample was necessary. The sensitivity for recent HEV infection was 77.8%. Conclusions This modified method is suitable for routine use in ordinary laboratories for its simplicity, practicality, precision and accuracy.