2014-10-24-世界卫生组织-WHO_BS_2014.2242_New_projects_requests_and_updates_for_development_of_WHO_reference_preparations_for_blood_products_and_in_vitro_diagnostic_devices_19页_296kb

Summary of WHO Expert Committee on Biological Standardization Document (2014)

Introduction

The World Health Organization (WHO) plays a critical role in providing global biological measurement standards, which are essential for ensuring the quality, safety, and efficacy of biological medicines and diagnostic devices. These standards support various assays and are used by manufacturers, regulatory authorities, blood establishments, and research institutions worldwide. The timely development and replacement of these standards are vital to keep up with scientific advancements and maintain global consistency in biological testing.

Proposed Projects for Endorsement

The following projects were proposed for the endorsement of the Expert Committee on Biological Standardization (ECBS):

1. WHO 2nd International Standard for Blood Coagulation Factor XI, Plasma

• Proposer: NIBSC
• Principal Contact: Elaine Gray
• Rationale: A new standard is required to replace the 1st IS, which is expected to run out in 2 years. The standard will be used for potency assignment and quality control of virus-inactivated plasma products.
• Anticipated Uses: Over 400 ampoules per year for laboratories and manufacturers.
• Materials: Normal plasma from a transfusion service.
• Collaborative Study: Value assignment relative to the 1st IS in an international study.
• Issues: Stability of FXI over long filling periods may limit batch size.
• Action Required: ECBS to endorse the proposal.
• Project Reference: NIBSC BIO-00076
• Priority Considerations:
  • Approval Status: 2 manufacturers of therapeutic FXI products.
  • Public Health Importance: Accurate measurement of FXI is essential for diagnosis and treatment of Haemophilia C.
  • Global Importance: Important for Haemophilia C and virus-inactivated plasma safety.
  • Global Need: High, as the current IS is widely used by regulators and manufacturers.

2. WHO 2nd International Standard for Activated Coagulation Factor IX (FIXa), Human

• Proposer: NIBSC
• Principal Contact: Elaine Gray
• Rationale: The 1st IS is nearing exhaustion, and a new standard is needed for potency control and quality assurance of FIX products.
• Anticipated Uses: At least 200 ampoules per year.
• Materials: Purified recombinant FIXa from a therapeutic manufacturer.
• Collaborative Study: Value assignment relative to the 1st IS, with molar concentration estimated by active site titration.
• Issues: None.
• Action Required: ECBS to endorse the proposal.
• Project Reference: NIBSC BIO-00075
• Priority Considerations:
  • Approval Status: 10 manufacturers of therapeutic FIX products.
  • Public Health Importance: Critical for Haemophilia B patients and reversal of oral anticoagulants.
  • Global Importance: High, as FIX is a major product for haemophilia treatment.
  • Global Need: High, due to the widespread use of the current IS.

3. WHO 1st International Reference Reagents for Anti-A and Anti-B in Intravenous Immunoglobulin

• Proposer: NIBSC
• Principal Contact: Susan Thorpe
• Rationale: Replacement of existing IRRs due to diminishing stocks.
• Anticipated Uses: Validation of haemagglutination tests for anti-A and anti-B in IVIG.
• Materials: IVIG.
• Collaborative Study: Collaborative study with EDQM and CBER/FDA.
• Issues: Criteria must be set for selecting laboratories to use the materials due to limited availability.
• Action Required: ECBS to endorse the proposal.
• Project Reference: BIO-00077
• Priority Considerations:
  • Approval Status: No antemortem diagnostic test for vCJD currently exists.
  • Public Health Importance: High, due to the risk of vCJD transmission via blood transfusion.
  • Global Importance: High, as IVIG is the leading plasma product globally.
  • Global Need: High, for validation of blood donor screening tests and prion removal devices.

4. WHO 2nd International Standards for Prostate Specific Antigen (Free) and Prostate Specific Antigen (90:10)

• Proposer: NIBSC
• Principal Contact: Chris Burns
• Rationale: Replacement of the 1st IS due to low stock and the need for harmonization of PSA assays.
• Anticipated Uses: Calibration of PSA immunoassays by manufacturers.
• Materials: PSA from a commercial source (Scripps Laboratories).
• Collaborative Study: Preparation using CLSI-recommended methods and value assignment by UV absorbance, amino acid analysis, and immunoassay.
• Issues: None.
• Action Required: ECBS to endorse the proposal.
• Project Reference: BIO00071
• Priority Considerations:
  • Approval Status: PSA assays are FDA approved and CE marked.
  • Public Health Importance: PSA testing is critical for prostate cancer diagnosis and management.
  • Global Importance: 8% of all cancers globally.
  • Global Need: Essential for accurate standardization and clinical decision-making.

5. WHO 1st International Standard for Anti-Mullerian Hormone (AMH), Human

• Proposer: NIBSC
• Principal Contact: Chris Burns/Jackie Ferguson
• Rationale: To improve the accuracy and comparability of AMH immunoassays, which are used in reproductive health and oncology.
• Anticipated Uses: Calibration and control of AMH immunoassays.
• Materials: Recombinant AMH.
• Collaborative Study: Two stages – pilot study and definitive evaluation by 8–10 laboratories.
• Issues: Stakeholders must agree on calibration approach.
• Action Required: ECBS to endorse the proposal.
• Project Reference: BIO-00072
• Priority Considerations:
  • Approval Status: CE marked IVD.
  • Public Health Importance: AMH is used in diagnosing ovarian reserve, hypogonadism, and reproductive conditions.
  • Global Importance: High, due to its inclusion in clinical guidelines.
  • Global Need: High, to harmonize and monitor emerging AMH assays.

6. Assignment of a Holotranscobalamin Value to the WHO International Standard for Folate and Vitamin B12

• Proposer: NIBSC
• Principal Contact: Susan Thorpe
• Rationale: To improve the measurement of vitamin B12 status by assigning a holotranscobalamin value to the existing IS.
• Anticipated Uses: Manufacturers of holoTC assays.
• Materials: WHO IS 03/178.
• Collaborative Study: Use of 12 labs using one or more of 3 methods.
• Issues: None.
• Action Required: ECBS to endorse the proposal.
• Project Reference: N/A
• Priority Considerations:
  • Approval Status: Intended for standardizing holoTC diagnostic tests.
  • Public Health Importance: Holotranscobalamin is the only biologically active form of B12.
  • Global Importance: High, due to the increasing use of holoTC in clinical diagnostics.
  • Global Need: High, for accurate measurement of B12 status and harmonization of assays.

Note on Submission

• Comments on the proposals must be received by 4 October 2014.
• Comments should be sent to WHO Secretariat, Technologies, Standards and Norms (TSN), or electronically to Dr David Wood (woodd@who.int).
• The outcome of the ECBS deliberations will be published in the WHO Technical Report Series.