The WHO international standard for anti-rubella was first established in the 1960s when clinical diagnostics were in their infancy. Since the endorsement of the first international standard for anti-rubella IgG (RUBI-1-94), new rubella vaccines have been developed and global coverage of rubella vaccination has increased. Methods used to measure concentrations of anti-rubella IgG have also evolved to rapid, high-throughput binding assays, which have replaced often cumbersome and highly technical functional assays. During this timeframe, the protective concentration of antibody was set at 10 IU/mL by extrapolation of functional assay correlates; however, the subpopulation of antibodies within a polyclonal serum that confer protection remained undefined. Anti-rubella assays have variable formats, including antigens used, such that the same clinical sample tested on different assays can report different values with potentially devastating consequences, such as recommending to terminate pregnancy. WHO convened a meeting of experts in the rubella field to discuss the use of RUBI-1-94 and the potential future role of this international standard. The main conclusions of this meeting questioned the appropriateness of 10 IU/mL as the cutoff for protection and acknowledged the continuing role of RUBI-1-94 as a reference preparation to address analytical sensitivity and assay variation.

中文翻译：

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世卫组织抗风疹国际标准：从其应用中学习。

世卫组织抗风疹国际标准于1960年代首次建立，当时其临床诊断还处于婴儿期。自第一个抗风疹IgG国际标准（RUBI-1-94）获得认可以来，新的风疹疫苗已经开发出来，风疹疫苗的全球覆盖率也有所提高。用于测量抗风疹IgG浓度的方法也已演变为快速，高通量的结合测定法，该测定法已取代了通常繁琐且技术含量高的功能测定法。在这段时间内，通过外推功能分析相关性将抗体的保护浓度设置为10 IU / mL。然而，在多克隆血清中赋予保护作用的抗体亚群仍然不确定。抗风疹的测定形式多种多样，包括使用的抗原，这样，在不同测定方法下测试的同一临床样品可能会报告具有潜在破坏性后果的不同值，例如建议终止妊娠。世卫组织召开了一次风疹领域专家会议，讨论RUBI-1-94的使用以及该国际标准的潜在未来作用。这次会议的主要结论质疑10 IU / mL作为保护的临界值是否合适，并承认RUBI-1-94作为参考制剂在解决分析灵敏度和测定变异方面的持续作用。世卫组织召开了一次风疹领域专家会议，讨论RUBI-1-94的使用以及该国际标准的潜在未来作用。这次会议的主要结论质疑10 IU / mL作为保护的临界值是否合适，并承认RUBI-1-94作为解决分析灵敏度和测定变异的参考制剂的持续作用。世卫组织召开了一次风疹领域专家会议，讨论RUBI-1-94的使用以及该国际标准的潜在未来作用。这次会议的主要结论质疑10 IU / mL作为保护的临界值是否合适，并承认RUBI-1-94作为解决分析灵敏度和测定变异的参考制剂的持续作用。