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Mass Value Assignment of Total and Subclass Immunoglobulin G in a Human Standard Anthrax Reference Serum

机译:人类标准炭疽参考血清中总和亚类免疫球蛋白G的质量值分配

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An anti-Anthrax Vaccine Adsorbed (anti-AVA) standard human reference serum pool, AVR414, has been prepared, and the total and protective antigen (PA)-specific immunoglobulin G (IgG) were quantified. AVR414 was prepared by plasmapheresis of healthy adults who had received a minimum of four subcutaneous injections of AVA. Mass values (in milligrams per milliliter) for total IgG and IgG subclasses 1 to 4 were determined by radial immunodiffusion. Anti-PA-specific IgG assignment (in micrograms per milliliter) was done by consensus of two complementary approaches: homologous enzyme-linked immunosorbent assay (ELISA) with affinity-purified anti-PA IgG as a calibrator and summation of mean PA-specific IgG subclass concentrations determined by IgG subclass-specific ELISA using the United States National Reference Preparation for Human Serum Proteins as a standard. The total IgG concentration assigned to AVR414 reference serum was 8.33 mg/ml. IgG subclass concentrations were the following: for IgG1, 4.48 mg/ml; for IgG2, 3.35 mg/ml; for IgG3, 0.37 mg/ml; and for IgG4, 0.30 mg/ml. The assigned mass value for total anti-PA-specific IgG was 141.2 μg/ml. Anti-PA-specific IgG subclass concentrations were the following: for IgG1, 79.6 μg/ml; for IgG2, 35.3 μg/ml; for IgG3, 3.2 μg/ml; and for IgG4, 25.3 μg/ml. Human reference serum pool AVR414 will have direct application in the standardization of anthrax serological assays, in reagent qualification, and as a standard for quantification of PA-specific IgG in humans who have been vaccinated with or otherwise exposed to Bacillus anthracis PA.
机译:制备了抗炭疽疫苗吸附标准人参考血清AVR414,并对总抗原和保护性抗原(PA)特异性免疫球蛋白G(IgG)进行了定量。 AVR414是通过健康成年人的血浆置换术制备的,他们至少接受了四次AVA皮下注射。通过放射免疫扩散测定总IgG和IgG亚类1至4的质量值(毫克每毫升)。通过两种互补方法的共识来完成抗PA特异性IgG的分配(以微克每毫升为单位):采用亲和纯化的抗PA IgG作为校准物的同源酶联免疫吸附测定(ELISA)和平均PA特异性IgG的总和IgG亚类特异性ELISA,以美国国家人血清蛋白国家参考制剂为标准,确定亚类浓度。分配给AVR414参考血清的总IgG浓度为8.33 mg / ml。 IgG亚类浓度如下:IgG1为4.48 mg / ml;对于IgG2,为3.35 mg / ml;对于IgG3,为0.37 mg / ml;对于IgG4,为0.30 mg / ml。总抗PA特异性IgG的指定质量值为141.2μg/ ml。抗PA特异性IgG亚类的浓度如下:IgG1为79.6μg/ ml;对于IgG2,为35.3μg/ ml;对于IgG3,为3.2μg/ ml;对于IgG4,为25.3μg/ ml。人类参考血清库AVR414将直接应用于炭疽血清学测定的标准化,试剂的鉴定,以及作为已经接种或暴露于炭疽芽孢杆菌的人类中PA特异性IgG定量的标准。 em> PA。

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