人免疫球蛋白中肠道病毒71型中和抗体效价的测定

采用经典微量细胞病变法,应用近两年分离自中国手足口病(HFMD)高发区的3株肠道病毒71型(EV71)病毒株,对中国不同血液制品厂家生产的35批人免疫球蛋白制品进行抗-EV71中和效价检测。结果显示,3株不同EV71病毒株间的抗-EV71中和效价差异均在4倍以内,差异无显著的统计学意义(F=2.323,P0.05)。根据这3株毒株检测结果判定,35批人免疫球蛋白的抗-EV71均为阳性,肌肉注射用免疫球蛋白(简称肌丙)的抗-EV71-GMTs(525.9)显著高于静脉注射用免疫球蛋白(简称静丙)的GMTs(252.3,F=66.518,P0.01)。30批静丙的抗-EV71-GMTs中和效价分布在128.0~384.0之间。应开展原料血浆中抗-EV71中和效价的筛选,研制高效价的EV71特异性免疫球蛋白制品,用于HFMD的治疗和预防。

The detection of anti-EV71 neutralizing titers in human immunoglobulins

To explore the anti-EV71 titers in human immunoglobulins in blood products made by different manufacturers in China.Thirty-five Lots of human immunoglobulins were tested for neutralizing antibodies to EV71 by microneutralization test with 3 different EV71 virus which were isolated from HFMD high-incidence area of China in the past two years.The results showed that the difference of anti-EV71 titers of human immunoglobulins was within 4-times between three different EV71 viruses.There is no significantly statistical difference among three groups（F=2.323,P〉0.05）.Based on different virus strains,the neutralizing antibodies to EV71 are all positive in thirty-five Lots of human immunoglobulins.The anti-EV71-GMTs of human immunoglobulins for intramuscular injection（IMIG;525.9,95%CI：372.6-679.1）are significantly higher than those of human immunoglobulins for intravenous injection（IVIG;252.3;F=66.518,P〈0.01）.The anti-EV71-GMTs of IVIG distributed from 128.0 to 384.0.In order to apply the human immunoglobulin for the treatment and prevention of HFMD more effectively,the anti-EV71 titers in plasma of raw materials should be tested to develop the high titers of EV71-specific immunoglobulin products.