2009-02-19-世界卫生组织-Development_of_WHO_Biological_Reference_Preparations_for_Blood_Safety-related_in_vitro_Diagnostic_Tests_28页_184kb

WHO 2nd Meeting on Biological Reference Preparations Development (Blood Safety-related IVD Tests) – Summary

This report summarizes the key discussions and recommendations from the 2nd meeting concerning the development of WHO Biological Reference Preparations (BRPs) for blood safety-related in vitro diagnostic tests. The meeting, held Feb. 17-18, 2009, involved WHO Collaborating Centres (CCs) and focused on emerging and re-emerging infectious pathogens and standardization efforts in diagnostics. Below is the organized summary:

1. WHO BRP Development Priorities

• A. HBV (Hepatitis B Virus):

  • HBV Strains: Need to establish international standards and panels covering prevalence strains beyond genotype A2, which are underrepresented in current reference materials.

• B. HCV (Hepatitis C Virus):

  • HCV Genotypes: Develope reference panels and international standards for all major HCV genotypes to enhance NAT assay sensitivity and standardization.

Hygiene And Safety

• Other Blood-borne Pathogens (e.g., HIV, T. cruzi, Parasites, etc.):
  • Bio reference preparations for HBV, HIV, DENV, WNV, T. cruzi, Toxoplasma, HCV core antigen, etc., are discussed for development and standardization to improve diagnostic accuracy and blood safety.

Bacterial Contamination

• Examination And Standardization: Protocols and reference standards for blood components' contamination by bacteria (e.g., Staphylococcus epidermidis, Escherichia coli) are proposed to ensure safety.

Transmissible Spongiform Encephalopathies (TSE)

• Further evaluation needed to caution TSE tests and reference materials for screening, given the uncertainty around testing sensitivity and donation risk.

Conclusion

The meeting emphasized the urgent need for WHO biological reference preparations in diagnostics linked to blood safety. Final decisions are scheduled for endorsement by the ECBS in 2009–2010.