RDT Evaluation Programme

Product Testing Round 2

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 first round of testing commenced in May 2008 at the Malaria Branch, Division of Parasitic Diseases, United States Centres for Disease Control and Prevention (CDC). Results of this testing round are expected to be available at the end of 2008, 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 2 of the Product Testing Programme is due to commence in April 2009. All information regarding the Product Testing Round 2 will be listed on this page.

An outline of the testing programme (Product Testing Overview), and the place of product testing within the quality assurance recommendations for malaria rapid tests of the WHO-FIND malaria RDT evaluation programme (WHO Malaria QA Update), are outlined below, together with notices to manufacturers concerning the Round 2 of Product Testing. Manufacturers who have not received previous notifications should contact WHO through the contact address below.


23 APRIL 2010
RESULTS OF WHO MALARIA RDT PRODUCT TESTING ROUND 2 (2009)
 
Full Report  
Summary Rounds 1 and 2


INTERACTIVE RDT PERFORMANCE GUIDE

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.

CHARACTERISTICS OF EVALUATION PANEL USED IN ROUND 2


25 APRIL 2009
MALARIA RAPID DIAGNOSTIC TESTS ACCEPTED INTO THE CURRENT ROUND OF PRODUCT TESTING Round 2 Product Summary List


METHODS MANUAL FOR PRODUCT TESTING OF MALARIA RAPID DIAGNOSTIC TESTS (WHO-FIND MALARIA RDT EVALUATION PROGRAMME)
Methods Manual Version Two


12 MARCH 2009
WHO MARALIA RDT PRODUCT TESTING PROGRAMME ROUND 2

1. Letter 4 to Manufacturers

2. Attachments
Annex 1: Changes to the Product Testing Standard Operating Procedures


09 JANUARY 2009
ACCEPTING FINAL LIST OF PRODUCTS FOR PARTICIPATING IN THE WHO MALARIA RDT PRODUCT TESTING PROGRAMME

1. Letter 3 to Manufacturers

2. Attachments
Annex 1: SOPs for RDT Product Submission to US CDC
Annex 2: Sample temperature monitor envelope with instructions on how
manufacturers should fill in information on envelopes. (Temperature monitors are optional - this information applies only to those who obtain temperature monitors from WHO)
Annex 3: Obtaining parasite dilution samples for own quality control testing (Optional)
Annex 4: Manufacturing site stability testing information pack

3. ISO issues: ISO 13485:2003 and ISO 9001:2000 (only for special cases)


25 NOVEMBER 2008
ACCEPTING EXPRESSION OF INTEREST IN PARTICIPATING IN THE WHO MALARIA RDT PRODUCT TESTING PROGRAMME

1. Letter 2 to Manufacturers

2. Attachments
Information for Manufacturers who have had Expression of Interest (EOI) accepted
Appendix B: Material Transfer Agreement/Confidentiality Agreement
Appendix C: Final Product list to be included in the program

30 SEPTEMBER 2008
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 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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