To address the biosafety and biosecurity concerns related to the manufacture of inactivated polio vaccine (IPV), several manufacturers started producing it from attenuated Sabin strains. Slight immunological differences between wild and attenuated strains create a challenge for testing IPV potency, which is defined as the content of protective D-antigen determined in an ELISA test. Some ELISA reagents selected for testing conventional IPV made from wild strains (cIPV) may not be suitable for testing Sabin IPV (sIPV). This paper describes an ELISA procedure using human monoclonal antibodies selected to capture equally well both wild and attenuated strains of poliovirus. A unique monoclonal antibody neutralizing all three serotypes of poliovirus was used as the detection antibody. The method was shown to detect only D-antigen of both conventional and Sabin IPV and to be strictly serotype-specific. The method is highly sensitive and robust and produces linear results in a wide range of concentrations. We have also found that reference standards used for measuring potency of cIPV and sIPV must be made from respective vaccines. This makes it impossible to cross-calibrate potency reagents made from heterologous vaccine and requires the establishment of a new unit to measure potency of sIPV that is different from conventional D-antigen unit.

中文翻译：

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通用ELISA用于定量灭活脊髓灰质炎疫苗中D抗原。

为了解决与生产灭活脊髓灰质炎疫苗（IPV）有关的生物安全性和生物安全问题，一些制造商开始使用减毒的Sabin毒株生产这种疫苗。野生株和减毒株之间的轻微免疫学差异为测试IPV效能提出了挑战，IPV效能的定义是在ELISA测试中确定的保护性D抗原含量。选择用于测试由野生株（cIPV）制成的常规IPV的某些ELISA试剂可能不适合测试Sabin IPV（sIPV）。本文介绍了一种使用人单克隆抗体的ELISA程序，该单克隆抗体被选择为能同时很好地捕获脊髓灰质炎病毒的野生株和减毒株。中和脊髓灰质炎所有三种血清型的独特单克隆抗体用作检测抗体。结果表明，该方法仅检测常规和Sabin IPV的D抗原，并且严格血清型特异性。该方法具有很高的灵敏度和稳定性，并能在各种浓度范围内产生线性结果。我们还发现，用于测量cIPV和sIPV效力的参考标准必须由各自的疫苗制成。这使得不可能交叉校准由异源疫苗制得的效价试剂，并且需要建立一种不同于常规D抗原单位的新单位来测量sIPV的效价。