RDT Evaluation Programme

Product Testing Round 3

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), is coordinating the development of a global specimen bank of cryo-preserved malaria parasite samples to support product testing (comparative performance evaluation of commercially-available antigen-detecting malaria rapid diagnostic tests - RDTs). The second round of testing commenced in April 2009 at the Malaria Branch, Division of Parasitic Diseases, United States Centers for Disease Control and Prevention (CDC). Testing is due to be completed in late 2009, and will give a comprehensive guidance on the potential performance characteristics of malaria RDTs to national malaria control programmes and other major procuring agencies. The Round 3 of the Product Testing Programme is due to commence in April 2010. All information regarding the Product Testing Round 3 will be listed on this page.

An outline of the testing programme (Methods Manual for Product Testing of Malaria Rapid Diagnostic Tests, v3) and notices to manufacturers concerning Round 3 of Product Testing are outlined below. Manufacturers who have not received previous notifications should contact WHO through the contact address below.

20 DECEMBER 2011
WHO information note on recommended selection criteria for procurement of malaria rapid diagnostic tests (RDTs)


16 DECEMBER 2011
Performance des tests de diagnostic rapide du paludisme
Bilan des résultats d’évaluation des produits par l’OMS : Séries 1-3 (2008-2011)

11 OCTOBER 2011
RESULTS OF WHO MALARIA RDT PRODUCT TESTING ROUND 3 (2010-2011)
 
Full Report
Summary Rounds 1-3

INTERACTIVE RDT PERFORMANCE GUIDE: http://www.finddiagnostics.org/programs/malaria/find_activities/
product_testing/malaria-rdt-product-testing/index.jsp


Interactive programme to assist in the selection of malaria RDTs based on the performance in the WHO Product Testing Round One Report, located on the FIND Website.


29 AUGUST 2011
CHARACTERISTICS OF EVALUATION PANEL USED IN ROUND 3

4 MAY 2010
FINAL LIST OF PRODUCTS ACCEPTED INTO ROUND 3 OF WHO/TDR-FIND MALARIA RDT PRODUCT TESTING PROGRAMME Round 3 Product Summary List

31 MARCH 2010

DEADLINE FOR SHIPMENT OF RDTs TO US CDC

22 FEBRUARY 2010
CONFIRMATION OF THE FINAL LIST OF PRODUCTS FOR WHO/TDR-FIND MALARIA RDT PRODUCT TESTING PROGRAMME: ROUND 3 AND OTHER INFORMATION

1. Letter 3B to Manufacturers

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

31 JANUARY 2010
ACCEPTANCE OF APPLICATION INTO WHO/TDR-FIND MALARIA RDT PRODUCT TESTING PROGRAMME: ROUND 3 AND OTHER INFORMATION

1. Letter 3A to Manufacturers

2. Attachments
Annex 1: Products to be Included for Evaluation
Annex 2: Order Form ; 'Manufacturers' Panel' - culture-derived P. falciparum samples
Annex 3: Information Pack on Manufacturing Site Stability Testing

10 DECEMBER 2009
ACCEPTANCE OF EOI IN WHO/TDR-FIND MALARIA RDT PRODUCT TESTING PROGRAMME: ROUND 3

1. Letter 2 to Manufacturers

2. Attachments
Annex 1: Order Form ; 'Manufacturers' Panel' - culture-derived P. falciparum samples

19 OCTOBER 2009
SEEKING EXPRESSION OF INTEREST IN PARTICIPATING IN THE WHO/TDR-FIND 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 fill out now)
Appendix C: Products to be included for Evaluation
(For information only – do not fill out now)
Appendix D: Joint-submission or Joint listing of products


CONTACT INFORMATION

For further information, please contact:



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