2021-11-30-世界卫生组织-WHO_lot_testing_programme_for_malaria_rapid_diagnostic_tests_RDTs_,_2007–2020_21页_365kb

WHO Malaria RDT Lot Testing Programme Summary (2007–2020)

Core Content

The WHO Malaria Rapid Diagnostic Test (RDT) Lot Testing Programme is an independent quality control initiative designed to assess the performance consistency of RDT lots. The goal is to ensure that only high-quality RDT lots are used in malaria-endemic countries. The programme is currently managed by the Research Institute for Tropical Medicine (RITM) in the Philippines, which evaluates RDT lots using standardized parasite samples.

Main Purpose

• Ensure Quality: Verify that RDT lots meet the required performance standards for clinical use.
• Track Performance: Monitor lot-to-lot variation in RDT performance.
• Support Procurement: Provide data to support the procurement of reliable and effective RDTs.

Key Information

• Testing Process: RDTs are sent globally for testing, and results are provided within 14 days of receipt.
• Testing Results: Reports include observations and photos of the RDTs, along with results of accessory assessments.
• Non-Routine Testing: Occasionally, non-routine testing is performed to confirm results from other labs, such as NIMR in India.

2020 Initial Testing Results

Summary of Results (2007–December 2020)

Summary of Annual Results (2007–2020)

2020 Pre-Qualified Products

• Percentage of Lots Included in WHO Pre-Qualified List: 99.60%
• Percentage of Lots Not Included: 0.40%
• Products Not Included:
  • Biocredit One Step Rapid Test Malaria Ag P.f/PAN (HRPII/pLDH); Catalog Number: C32RHA25; Manufacturer: RapiGEN, Inc.
  • Parabank Device Rapid Test for Malaria PAN; Catalog Number: 503040025; Manufacturer: Zephyr Biomedicals

Annual Demand for Malaria RDT Lot Testing

• The programme was launched in 2007.
• From 2011–2017, lot testing was mandatory for all Global Fund grant recipients.
• The peak demand was in 2013, followed by a decrease in subsequent years.
• There was a drastic drop in 2019, with a near two-fold increase in 2020.

Requesters and Recipient Countries in 2020

• Procurement Agencies: 31%

• RDT Manufacturers: 28%

• Country Programmes: 27%

• Other Requesters: 12%

• UN and NGOs: 2%

• Countries Represented:

  • Nigeria
  • Uganda
  • Sudan
  • Ghana
  • Laos
  • Côte d'Ivoire
  • Denmark
  • Non-EU
  • Bangladesh
  • Cambodia
  • Somalia
  • Mozambique
  • Angola
  • Kenya
  • Netherlands
  • Burundi
  • Papua New Guinea
  • Guinea
  • Nepal
  • Eritrea
  • Bangui
  • China
  • Togo
  • Niger
  • Malawi
  • Tanzania
  • Belgium
  • Mali
  • UAE
  • Zambia
  • Pakistan
  • Zimbabwe
  • Bhutan
  • Dominican Republic
  • Madagascar
  • Democratic Republic of Congo
  • France
  • Liberia
  • Indonesia
  • Burma
  • Senegal
  • Afghanistan
  • Austria
  • Botswana
  • Haiti
  • Burkina Faso
  • Philippines
  • Ivory Coast
  • Brazil
  • Chad
  • Sierra Leone
  • Cameroon
  • Amsterdam
  • South Africa
  • Saudi Arabia

Key Observations

• Most RDT lots passed initial and long-term testing.
• The number of failed lots has significantly decreased since 2013.
• The majority of lot testing requests in 2020 came from Procurement Agencies and RDT Manufacturers.
• The WHO Pre-Qualified List includes the vast majority of tested lots, with only a small percentage not meeting standards.