WHO-Malaria Product Testing Programme – Round 2

APPENDIX A:Expression of Interest – Notification of interest to submit an antigen- detecting malaria rapid diagnostic test to the WHO Malaria RDT Product Testing Programme

Company name / Product Name / Catalogue Number / Plasmodium species targeted1 / Target antigen(s) / Format2
Dipstick: D
Cassette: Ca
Card: Cd / Packaging
(Individual or bulk). / Number of tests per box / All materials can be included?
(lancets, swabs,
wells if required)
A
B
C
D
E
Product name / Shelf life / Storage temperature recommended by manufacturer / Temperature stability data on which shelf-life is based('Accelerated'
or 'Real time') / Contact person
(If appropriate) / Address
(for procuring tests) / Email
URL
Contact numbers
A
B
C
D
E
  1. P: falciparum, V: vivax, O: ovale, M: malariae, Pan: all. 2.'Dipstick' refers to simple nitrocellulose strip which requires placement in well. Cassette / card indicates strip enclosed in (plastic) cassette or card.

Signature______Name ______Designation / position ______

NOTES:

  • Please note that the information submitted on this form should be accurate for WHO publication purposes
  • This Expression of Interest should be submitted to WHO [, and David Bell, WHO – Regional Office for the Western Pacific, UN Avenue, Ermita, Manila, Philippines] by 14th November 2008.
  • Manufacturers should ensure that receipt is acknowledged. The provision of the required product details in this table, and the provision of evidence demonstrating compliance with the requirements set forth in Annex 1 point C, is necessary in order for the products to be considered by WHO for inclusion in the initial round of product testing.
  • Only products listed above maybe included in the list of products finally submitted to the Product Testing Programme. WHO reserves the right to limit the maximum number of products that can be submitted by manufacturers, if the listed products in the EOI is beyond the capacity for testing by the Programme in a single round of Product testing.Manufacturer will be notified accordingly.
  • If co-listing any product, Appendix D must also be completed and submitted with the EOI.
  • WHO will notify a manufacturer if and when products have been accepted for this round of Product Testing Programme.
  • The submission of an Expression of Interest and/or the aforesaid evidence will neither obligate WHO to accept, nor obligate the manufacturer to actually provide, the listed products for product testing.

CHECKLISTS for Submission of EOI

1. ISO Certificate

2. Heat Stability Protocol

3. Completed and signed product specifics (Appendix A)
4. Completed and signed Co-listing details (if relevant) (Appendix D)
(signed by both the manufacturer and the owner of the product)

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