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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 detect the neutralizing antibody level of enterovirus 71 (EV71) in the plasma of raw materials by using the method of microcytopathology to determine the screening standard of plasma for the production of EV71 immunoglobulin. Methods We established a micro-cytopathic method to detect the neutralizing antibody titer of EV71. Three batches of quality control plasma were tested to verify the repeatability of the method. Results The coefficient of variation (CV) of the titer of plasma neutralizing antibody (EV71) in the plasma of high (1: 400) and low (1:50) mice were 22.7% and 27.3%, respectively Titer <1: 8, about 60% neutralizing antibody titers ≥ 1: 8. Conclusion Microtubular cytopathic effect assay can be used to detect the neutralizing antibody of EV71 in the plasma of raw material. About 23% of the antibody titer of neutralizing antibody of EV71 reaches 1:32, which can be used in the production of EV71 immunoglobulin.