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目的制备抗乙型脑炎病毒阳性血清抗体效价参考品。方法评估乙脑病毒IgG酶联免疫试剂盒定量检测不同浓度阳性血清抗体的线性范围、准确性、精密性及特异性,并以正常血清及其他免疫球蛋白产品为对照,对该参考品抗体效价定位进行适用性比较。结果不同浓度阳性血清的线性范围为0.625～10IU/ml,抗体效价回收率为91.2%～112.8%,试验内变异系数≤7.8%,正常血清与阳性血清的乙脑抗体效价相差15倍。试验用的阳性血清乙脑病毒抗体效价设为10U/ml时,在特定的疫苗免疫程序下,效价峰值期能够实现合格血浆≥50%的收获率。结论兼顾原料血浆的可获取性与产品临床效果的难以替代性,特定阳性血清定位为10U/ml。
Objective To prepare anti-Japanese encephalitis virus-positive serum antibody titers. Methods To evaluate the linear range, accuracy, precision and specificity of quantitative ELISA for the detection of antibodies against Japanese encephalitis virus (JEV) by enzyme linked immunosorbent assay (ELISA) with normal serum and other immunoglobulin products. Price positioning for applicability comparison. Results The linear range of the positive serum of different concentrations was 0.625-10IU / ml, the titer of the antibody was 91.2% ~ 112.8%, the coefficient of variation within the experiment was less than or equal to 7.8%, and the titer of JE antibody between normal serum and positive serum was 15 times different. Test positive for serum JE virus titer set to 10U / ml, under the specific vaccine immunization program, peak titers can achieve the qualified plasma ≥ 50% yield. Conclusions Taking both the availability of raw plasma and the intractability of the clinical efficacy of the product, the specific positive serum is located at 10 U / ml.