2000-09-21-世界卫生组织-WHO_Consultation_on_International_Biological_Standards_for_in_vitro_Diagnostic_procedures_19页_125kb

Summary of WHO Consultation: Development of International Biological Standards for In Vitro Diagnostic Procedures

• Background: Since the 1920s, WHO promoted biological standardization primarily for therapeutic products, transitioning in the last 30 years to include clinical diagnostics. A 2000 consultation aimed to address scientific issues and prioritize development of international biological reference materials for global public health relevance.

• Key Outcomes:

  • Proposed classification of analytes:
    • Category A: Traceable to SI units (mole/L), well-defined compounds (e.g., glucose).
    • Category B: Not traceable to SI units, expressed in arbitrary units (e.g., WHO International Units), include heterogeneous substances (e.g., proteins, allergens).
  • Defined the "Reference System" comprising reference material, reference measurement procedure (ICRMP), and reference laboratories to ensure traceability, uncertainty quantification, and commutability.

• Scientific Issues & Priority Projects:

  • For Category B analytes, standardization remains challenging due to heterogeneity (e.g., glycosylation affecting immunoreactivity). Gaps exist in:
    • Immunology (e.g., GAD65 antibodies)
    • Haematology (cell counting, haemoglobinopathies)
    • Virology (e.g., HBsAg, anti-HCV, HIV markers)
    • Diabetes (e.g., hemoglobin A1c, insulin units)
    • Microbial agents important for transfusion safety.
  • New reference materials proposed for HCG isoforms, Lp(a), myoglobin, Troponin, osteocalcin, and molecular markers.

• Regulatory Aspects:

  • EU harmonization via Directives, while Japan and USA focus on regional or international standards.
  • Called for global consensus to prevent duplication in calibration and avoid regional requirements.

• Recommendations:

  • Proceed cautiously with the reference system concept for Category B analytes, as it may not universally apply.
  • Develop reference systems with agreed-upon definitions and global collaboration via WHO.
  • Ensure commutability with clinical samples and reduce measurement uncertainty.

This consultation highlighted the need for continued international collaboration among WHO, professional societies, and regulatory agencies to standardize diagnostics and improve global public health.