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目的:对人免疫球蛋白和肠道病毒71型和抗体效价进行测定。方法:采用微量细胞病变法,以试验和毒株-01、毒株-02进行检测,对比三种试验检测结果的差异。结果:检测人免疫球蛋白中肠道病毒71型中和抗体效价范围在105~256之间,效价≥239为12批,占总批数的40%,效价≥256为10批,占总批数的33.3%;毒株-01检测效价范围约为224~476,平均滴度为334。3批静注肠道病毒71型平均滴度为1400,高于3个厂家10批人免疫球蛋白含量,(P<0.05)。毒株-02检测效价范围在195~620之间,平均滴度为330,与毒株-01的检测结果差异不明显,不具有统计学意义(P>0.05)。毒株-01和毒株-02检测的17批人免疫球蛋白的肠道病毒71型中和抗体平均滴度为333,效价≥256,可应用于临床重症治疗。结论:经检测,我国各厂家中的人免疫球蛋白中的肠道病毒71型中核抗体效价均为阳性,静注肠道病毒71型免疫球蛋白高于普通人免疫球蛋白的中和效价。
Objective: To determine the titer of human immunoglobulin and enterovirus 71 and antibody. Methods: The micro-cytopathic method was used to test and test strains-01, strain-02, compare the differences between the three test results. Results: The titer of neutralizing antibody against enterovirus 71 in human immunoglobulin ranged from 105 to 256, the titer of ≥239 was 12 batches, accounting for 40% of the total batches, the titer ≥256 was 10 batches, Accounting for 33.3% of the total number of batches; strain-01 detection potency range of about 224 ~ 476, the average titer of 334.3 batch intravenous enterovirus 71 average titer of 1400, higher than the three manufacturers 10 Human immunoglobulin content, (P <0.05). The detection range of strain-02 ranged from 195 to 620 with an average titer of 330, which was not significantly different from that of strain-01 (P> 0.05). The average titer of enterovirus 71 neutralizing antibody of 17 batches of human immunoglobulin detected by strain-01 and strain-02 was 333 and the titer was ≥256, which could be used in clinical critically ill treatment. CONCLUSIONS: The detection of enterotoxigenic 71 nucleocapsid antibody in human immunoglobulin in each manufacturer in our country was positive. The neutralizing effect of IVECV 71 immunoglobulin was higher than that of normal human immunoglobulin price.