2015-10-24-世界卫生组织-WHO_BS_2015.2275_Requests_to_initiate_new_WHO_reference_material_projects_for_in_vitro_diagnostic_devices_and_reagents_37页_565kb

WHO/BS/2015.2275 is a document from the World Health Organization (WHO) Expert Committee on Biological Standardization, outlining new proposals for international reference materials and reagents for in vitro diagnostic devices. It was published in October 2015 to invite expert comments by September 14, 2015, focusing on standardization for various diseases. Below is a summary of the key elements:

• Document Overview: This report details proposed WHO reference material projects aimed at improving global health through standardized diagnostics. Projects cover a range of infectious diseases (e.g., Ebola, malaria, HIV, hepatitis) and non-infectious conditions like cancer diagnostics. Each proposal includes rationale for urgency, anticipated uses in quality control, and requirements for expert committee endorsement (ECBS). Endorsement is needed for most, with ECBS meetings scheduled to review.

• Key Proposals: Many proposals address public health emergencies and neglected diseases. For example:

  • Ebola-related projects (antibodies, RNA NAT) support response to the Ebola crisis, enabling better assay calibration and serology standardization.
  • Hepatitis B and C projects aim to replace or validate standards for nucleic acid amplification tests (NATs) to improve blood safety and infection management.
  • HIV and malaria proposals focus on diagnostics for monitoring treatment and surveillance, with efforts to develop reference panels for antigens and antibodies.
  • Other projects cover rare conditions like Babesiosis and varicella, emphasizing the need for harmonized testing globally.

• Common Themes: The proposals stress the importance of standardization for reliable diagnostic performance in low- and middle-income countries, reduced errors in clinical practice, and better control of infectious diseases through improved assay validation and seroepidemiology. Most projects require collaborative studies to assess commutability and potency, ensuring materials are fit for international use.

• Call for Action: WHO invites comments from experts on all proposals to inform ECBS decisions. The outcomes, including formal endorsement and publication in WHO Technical Report Series, will guide future WHO priorities and enhance global health standards.