In recent years, several modified recombinant factor (F) VIII and FIX therapeutics with extended half-life have been licensed internationally for the treatment of haemophilia. Safe and effective use of these products requires monitoring of factor activity in patient plasma. The potency of all FVIII and FIX products is currently assigned in International Units (IU) which anchors the relationship between potency labelling, dosing and clinical monitoring. However, varying degrees of discrepancies in factor activity assays are observed between and within the factor activity analytical methods (one-stage clotting and chromogenic), when measuring these modified products against plasma and plasma-derived (concentrate) International Standards (IS) or in-house reference standard traceable to the IS. Availability of product-specific reference reagents would mitigate assay discrepancies, facilitate independent testing of assay methods and reagents, and ensure long-term continuity of the IU related to each product. A hearing meeting was organised by the WHO to discuss the requirements for product-specific reference materials for these products and whether these reference materials should be produced by the WHO. Advantages and disadvantages of product-specific reference materials were identified and discussed.

近年来，几种具有延长半衰期的改良重组因子 (F) VIII 和 FIX 疗法已获得国际许可，用于治疗血友病。安全有效地使用这些产品需要监测患者血浆中的因子活性。目前，所有 FVIII 和 FIX 产品的效力均以国际单位 (IU) 为单位进行分配，该单位确定了效力标签、剂量和临床监测之间的关系。然而，当根据血浆和血浆来源（浓缩）国际标准 (IS) 或在测量这些改良产品时，在因子活性分析方法之间和内部观察到不同程度的差异。 - 可追溯到 IS 的内部参考标准。产品特定参考试剂的可用性将减少检测差异，促进检测方法和试剂的独立测试，并确保与每个产品相关的 IU 的长期连续性。WHO 组织了一次听证会，讨论这些产品对特定产品参考材料的要求，以及这些参考材料是否应该由 WHO 生产。确定并讨论了特定于产品的参考材料的优缺点。WHO 组织了一次听证会，讨论这些产品对特定产品参考材料的要求，以及这些参考材料是否应该由 WHO 生产。确定并讨论了特定于产品的参考材料的优缺点。WHO 组织了一次听证会，讨论这些产品对特定产品参考材料的要求，以及这些参考材料是否应该由 WHO 生产。确定并讨论了特定于产品的参考材料的优缺点。