微量细胞病变法检测原料血浆中肠道病毒71型中和抗体水平

Determination of Neutralizing Antibody Level against Enterovirus 71 in Source Plasma by Micro-cytopathic Method

目的应用微量细胞病变法检测原料血浆中肠道病毒71型(Enterovirus 71,EV71)中和抗体水平,以确定可供EV71免疫球蛋白生产用的原料血浆筛选标准。方法建立检测EV71中和抗体效价的微量细胞病变法,检测3批质控血浆,验证该方法的重复性;并对1 238份原料血浆进行检测。结果微量细胞病变法检测高(1∶400)、低(1∶50)效价质控血浆EV71中和抗体效价的变异系数分别为22.7%和27.3%;约40%的原料血浆中和抗体效价<1∶8,约60%的中和抗体效价≥1∶8。结论微量细胞病变法可用于原料血浆中EV71中和抗体的检测,约23%的献浆员的EV71中和抗体效价达1∶32以上,可用于EV71免疫球蛋白的生产。

Objective To test the neutralizing antibody level against enterovirus 71（EV71） in source plasma by micro-cytopathic method so as to determine the criteria for screening of source plasma for production of EV71 immunoglobulin.Methods The micro-cytopathic method for determination of neutralizing antibody titer against EV71 was developed,of which the reproducibility was verified by using three batches of quality control plasma.A total of 1 238 source plasma samples were determined by the developed method.Results The variation coefficients of determination results of quality control plasma samples with high（1 ∶ 400） and low（1 ∶ 50） neutralizing antibody titers against EV71 by micro-cytopathic method were 22.7% and 27.3% respectively.The neutralizing antibody titers against EV71 were less than 1 ∶ 8 in about 40% of the source plasma samples,while was not less than 1 ∶ 8 in about 60% of the samples.Conclusion Micro-cytopathic method may be used for the determination of neutralizing antibody against EV71 in source plasma.The plasma of about 23% of donors reached neutralizing antibody titers against EV71 of more than 1 ∶ 32,which might be used for production of EV71 immunoglobulin.