2015-10-24-世界卫生组织-WHO_BS_2015.2274_Requests_to_initiate_new_WHO_reference_material_projects_for_blood_products_9页_246kb

This document, prepared by the WHO Secretariat with inputs from WHO Collaborating Centres, presents four proposals for new WHO reference material projects focused on blood products. The Expert Committee on Biological Standardization (ECBS) is invited to consider these proposals, and comments must be submitted by 14 September 2015. The proposals address the need for global measurement standards to ensure the quality and safety of biological medicines, particularly in the context of blood-derived products. Key aspects include:

• Proposal 1: Establishing the first international reference reagent for human activated factor Xa (FXa) to replace a bovine-based non-WHO reference material. This aims to standardize measurements for products like Factor Eighth Aug正常的activated prothrombin complex concentrate (FEIBA) and therapeutic Factor X concentrates, with potential applications in inhibitor measurement.

• Proposal 2: Developing a first international reference panel for procoagulant activity in human immunoglobulins (IVIG), following concerns over thrombotic events from IVIG administration. This will aid in harmonizing assay methods for safety monitoring, with low, intermediate, and high activity materials needed. No unit assignment is required, and it will serve as a control standard.

• Proposal 3: Requesting endorsement for the fifth WHO International Standard for thromboplastin, rabbit plain, due to stock depletion. This will involve an international collaborative study to assign the International Sensitivity Index, supporting calibration for reagents in point-of-care devices.

• Proposal 4: Seeking endorsement for the fifth WHO International Standard for recombinant thromboplastin, human, addressing similar depletion issues as Proposal 3. It will support vitamin K-antagonist therapy monitoring globally.

Overall, these proposals underscore the importance of timely reference materials for regulatory compliance, public health safety, and standardized quality control in the global healthcare system. The ECBS decision, based on stakeholder input, will influence future WHO activities.