RDT Evaluation Programme

Product Testing Round 1

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), involving 40 products from 21 manufacturers. 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. 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 first testing round. A further round of product testing is expected to be announced later in 2008. Manufacturers who have not received previous notifications should contact WHO through the contact addresses below.

25 APRIL 2009
RESULTS OF PRODUCT TESTING ROUND 1
Full Report
Executive Summary (English)
Résumé d'orientation (Français)


INTERACTIVE RDT PERFORMANCE GUIDE:

Interactive programme to assist in selection of malaria RDTs based on performance in the WHO Product Testing round one report, located on the FIND website.


CHARACTERISTICS OF EVALUATION PANEL USED IN ROUND 1


15 JUNE 2008
STABILITY ASSESSMENT AT MANUFACTURING SITE

1. Letter to Manufacturers

2. Attachments
Information on Manufacturing Site Stability Test
Stability Test Protocol
Manufacturing Site Stability test results form 036a


2 JUNE 2008
MALARIA RAPID DIAGNOSTIC TESTS ACCEPTED INTO THE CURRENT ROUND OF PRODUCT TESTING
Round 1 Product Summary List


15 MAY 2008
METHODS MANUAL FOR PRODUCT TESTING OF MALARIA RAPID DIAGNOSTIC TESTS (WHO-FIND MALARIA RDT EVALUATION PROGRAMME)
Methods Manual Version One


24 MARCH 2008
EVALUATION OF RAPID DIAGNOSTICS FOR MALARIA

Letter to Manufacturers for Round One of Product Testing
Annex One
Annex Two
Annex Three


05 MARCH 2008
OVERVIEW OF MALARIA RDT PRODUCT TESTING PROGRAMME AND TESTING PANELS AGAINST WHICH EVALUATION WILL TAKE PLACE
Product Testing Overview


28 JANUARY 2008
AVAILABILITY OF MANUFACTURER PANELS - FURTHER INFORMATION ON PRODUCT TESTING


1. Letter to Manufacturers

2. Information in attachments for manufacturers previously notified of acceptance into the product-testing programme:

(1) Limit on products to be submitted by each manufacturer (3 products per manufacturer).
(2) Availability of panels of recombinant antigen for preliminary testing of products by manufacturers.
(3) Details of payment to be made on submission of RDTs for testing.
(4) Summary of product testing procedure.
(5) Provisional timeline for product testing.
(6) Relationship of product testing to WHO RDT procurement, and to WHO prequalification of malaria RDTs.

Details of actual submission of product will be available at a later date. Note that panels are currently available only to manufacturers notified of acceptance to the first round of product testing, to assist manufacturers in decisions on product submission. Further panels will be available to all manufacturers later in 2008.


31 OCTOBER 2007
EXPRESSION OF INTEREST IN FIRST ROUND OF PRODUCT TESTING (CLOSED)

1. Clarification of implications for WHO procurement and prequalification of malaria rapid diagnostic tests, and extension of deadline for submission of EOI.

WHO Malaria Diagnostics Evaluation Programme, WHO Procurement Through Webbuy and Prequalification

Overview of malaria RDT product testing programme and testing panels against which evaluation will take place.


28 AUGUST 2007
SEEKING EXPRESSION OF INTEREST IN PARTICIPATING IN WHO MALARIA DIAGNOSTICS EVALUATION PROGRAM

1. Letter to Manufacturers

2. Attachments
Annex 1: Information for Manufacturers on WHO Malaria Diagnostics Evaluation Programme
Annex 2: Sample WHO Standard Confidentiality Agreement


CONTACT INFORMATION

For further information, please contact:


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