INTERNATIONAL COLLABORATIVE STUDY OF POLIO REAGENTS

一种测定灭活剂效价的标准重复性方法 脊髓灰质炎病毒(IPV)体外疫苗将是迈向 根除小儿麻痹症。对脊髓灰质炎的保护是由 具有“D”抗原特异性的中和抗体。我们已经开发出一种 使用多克隆抗体(D特异性)进行的酶联免疫吸附试验 用来侦测。用我们的试剂作为我们检测血清的标准 其他合作实验室能够测量 IPV疫苗。我们能够检测在四个月内制备的多克隆血清 不同的物种包括：兔子、奶牛、马和山羊。我们也是 能够比较两种不同的IPV疫苗制剂，其中一种是由 野生脊髓灰质炎病毒株和其他来自Sabin株的病毒。此外，我们 能够检测用野生型或沙宾制备的试剂 脊髓灰质炎病毒株。我们已经完成了对可用的 多克隆血清，并正在评估不同的单抗 抗体与各种多克隆抗体相结合。我们发现， 针对野生型脊髓灰质炎病毒株的试剂在ELISA法中起作用 用Sabin来源的IPV进行检测，反之亦然。这些发现表明， 制备灭活疫苗时的减毒株(沙宾) 保留与灭活的野生型菌株相同的抗原。是否 用于配制三价IPV的等量D抗原单位 从野生型毒株派生的IPV必须来自萨宾 菌株尚不清楚。我们计划继续进行这项评估，并 在进行酶联免疫吸附试验评估的同时，包括体内效力研究。 此外，血清将在我们的实验室进行中和试验 抗体。我们的单抗的位置特异性将是 是由我们的一个合作者决定的。

A standard reproducible method for determining the potency of inactivated poliovirus (IPV) vaccines in vitro would be an important advance toward the eradication of polio. Protection against polio is provided by neutralizing antibodies with "D" antigen specificity. We have developed an ELISA test in which polyclonal antibody (which is "D" specific) is used for detection. Using our reagents as the standard we examined sera from other collaborating laboratories for the ability to measure the potency of IPV vaccines. We were able to examine polyclonal sera prepared in four different species including: rabbits, cows, horses and goats. We were also able to compare two different vaccine preparations of IPV, one made from wild poliovirus strains and the other from Sabin strains. Furthermore, we were able to examine reagents prepared with either the wildtype or Sabin strains of poliovirus. We have completed our evaluation of the available polyclonal sera and are in the process of evaluating different monoclonal antibodies with the various polyclonal antibodies. We have found that reagents prepared against wildtype poliovirus strains work in the ELISA assay with Sabin derived IPV and vice versa. These findings suggest that the attenuated strains (Sabin) when prepared as an inactivated vaccine retain antigens in common with the inactivated wildtype strains. Whether equivalent amounts of D antigen units used to formulate trivalent IPV derived from wildtype strains is necessary for IPV derived from Sabin strains is not yet known. We plan to continue with this evaluation and to include in vivo studies of potency in parallel with the ELISA evaluation. In addition, the sera will be tested in our laboratory for neutralizing antibodies. The site-specificity of our monoclonal antibodies will be determined by one of our collaborators.