RDT Evaluation Programme

Product Testing Round 4

Information for Manufacturers and Procurers
on progress towards
Product Testing of Malaria Rapid Diagnostic Tests

The World Health Organization (WHO), with the Foundation for Innovative New Diagnostics (FIND), and other partners are conducting a global product testing programme for malaria RDTs (comparative performance evaluation of commercially-available antigen-detecting malaria rapid diagnostic tests), based on testing against a panel derived from a global specimen bank of cryo-preserved malaria parasite samples . The evaluation is undertaken at the Malaria Branch, Division of Parasitic Diseases, United States Centers for Disease Control and Prevention (CDC). Two rounds have been completed. Round 3, commenced in April 2010, is due to be completed in the first quarter of 2010, adding to existing comprehensive guidance on the potential performance characteristics of malaria RDTs to national malaria control programmes and other major procuring agencies.

Round 4 of the WHO Product Testing Programme is due to commence in June 2011, and requests for participation in Round 4 must be submitted to WHO by 01 February 2011 (see below). All information regarding Product Testing Round 4 will be listed on this page.

14 December 2012

RESULTS OF WHO MALARIA RDT PRODUCT TESTING ROUND 4 (2012)
Final report

INTERACTIVE RDT PERFORMANCE GUIDE
Interactive programme to asist in the selection of malaria RDTs based on the performance in the WHO Product Testing Round One Report, locatd on the FIND Website.

CHARACTERISTICS OF EVALUATION PANEL USED IN ROUND 4 

25 July 2011
FINAL LIST OF PRODUCTS ACCEPTED INTO ROUND 4 OF WHO MALARIA RDT PRODUCT TESTING PROGRAMME
Round 4 Product Summary List

31 May 2011
DEADLINE FOR RECEIPT OF RDTs AT US CDC

5 April 2011
CONFIRMATION OF THE FINAL LIST OF PRODUCTS FOR WHO MALARIA RDT PRODUCT TESTING PROGRAMME: ROUND 4 AND OTHER INFORMATION

  1. Letter 3 to Manufacturers
  2. Attachments
    Annex 1: SOPs for transportation of products to US CDC
    Annex 2: Temperature monitor envelope and information needed
    Annex 3: Availability of Panels of Cultured P. falciparum parasites for Preliminary Testing of Products by Manufacturers (optional)
    Annex 4: Information Pack on Manufacturing Site Stability Testing


8 February 2011
ACCEPTANCE OF EOI IN WHO MALARIA RDT PRODUCT TESTING PROGRAMME: ROUND 4

  1. Letter 2 to Manufacturers
  2. Attachments

17 December 2010
SEEKING EXPRESSION OF INTEREST IN PARTICIPATING IN THE WHO MALARIA RDT PRODUCT TESTING PROGRAMME

  1. Letter 1 to Manufacturers
  2. Attachments
    Annex 1: General Information on Programme and Timeline
    Annex 2: Definition on Production ‘Lot’
    Annex 3: Information on Internal Heat stability Protocol
    Appendix A: Expression of Interest (EOI)
    Appendix B: Material Transfer Agreement/Confidentiality Agreement
    (For information only – do not complete now)
    Appendix C: Products to be included for Evaluation
    (For information only – do not complete now)
    Appendix D: Joint-submission or Joint listing of products

CONTACT INFORMATION

Further details, and requirements for product inclusion, can be acquired by sending an email to:


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