INTERNATIONAL COLLABORATIVE STUDY OF POLIO REAGENTS

一个标准的可重复的方法来确定效力的 体外灭活脊髓灰质炎病毒疫苗（IPV）将是一种重要的 为消灭脊髓灰质炎而努力。 预防小儿麻痹症是 由具有“D”抗原特异性的中和抗体提供。 我们 已经开发了一种ELISA测试，其中单克隆抗体（即“D”） 特异性）用于检测。 使用我们的试剂作为标准品， 检查了来自其他合作实验室的血清， 衡量IPV的效力。 我们能够检测多克隆捕获 或在四种不同物种中制备的检测血清，包括： 兔子、牛、马和山羊。 我们还比较了两个 不同的IPV疫苗制剂，一种由野生脊髓灰质炎病毒制成， 另一个来自Sabin菌株。 此外，我们还可以检查 用野生型或Sabin株制备的多克隆血清 脊髓灰质炎病毒。 我们已经发现，针对野生型 脊髓灰质炎病毒株在ELISA中与Sabin衍生的IPV反应良好， 反之亦然 大多数单克隆抗体与野生型抗体反应良好。 或Sabin衍生的疫苗，无论其使用的菌株 准备. 这些发现表明减毒株（Sabin） 当制备成灭活疫苗时， 灭活的野生型菌株。几种单克隆抗体， 被发现是菌株特异性的，并且一些与任何菌株都不反应。 脊髓灰质炎病毒在ELISA中。 Sabin株中是否存在等效D Ag单位 和野生型IPV将提供相同的体内免疫原性， 还不知道。 一种ELISA试验，它结合了交叉反应，以及 菌株特异性单克隆抗体将是一种有用的工具， 在体外比较野生型和Sabin衍生疫苗的效力。

A standard reproducible method for determining the potency of inactivated poliovirus vaccines (IPV) 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 monoclonal 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. We were able to examine polyclonal capture or detection 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 and the other from Sabin strains. Furthermore, we were able to examine polyclonal sera prepared with either the wildtype or Sabin strains of poliovirus. We have found that reagents prepared against wildtype poliovirus strains react well in the ELISA with Sabin derived IPV and vice versa. The majority of monoclonal antibodies react well with wild or Sabin derived vaccines irrespective of the strain used in their preparation. These findings suggest that the attenuated strains (Sabin) when prepared as an inactivated vaccine retain antigens in common with the inactivated wildtype strains. Several monoclonal antibodies were found to be strain specific and a few non-reactive with either strain of poliovirus in the ELISA. Whether equivalent D Ag units in Sabin strain and wild type IPV will provide the same in vivo immunogenicity is not yet known. An ELISA test which incorporates cross-reactive as well as strain specific monoclonal antibodies will be a useful tool for comparing the potency of wild-type and Sabin derived vaccines in vitro.