Call for expressions of interest for Round 8 of the WHO Malaria RDT Product Testing Programme
WHO, together with the Foundation for Innovative New Diagnostics (FIND), coordinates a global product testing programme for malaria rapid diagnostic tests (RDTs). The evaluation is undertaken at the Division of Parasitic Diseases and Malaria of the United States Centers for Disease Control and Prevention (CDC). Performance assessment is based on testing RDTs against a panel derived from a global specimen bank of cryo-preserved malaria parasite samples.
Seven rounds of testing have been completed since 2008. Results for Round 7 are expected to be published during the first quarter of 2017.
Round 8 of the WHO Product Testing Programme is due to commence in February 2017. The deadline for submitting an expression of interest (EOI) is 10 November 2016.
If your company did not automatically receive a login to the EOI web-form, then you may request one by sending an email to: email@example.com with the subject heading: "Round 8 request login for EOI"
Revision to WHO recommendations for malaria RDT procurement
Following on changes to WHO procedures for malaria RDT procurement eligibility announced in May 2016, participation in the product testing scheme also requires an application to the WHO Prequalification of in vitro diagnostics programme. In addition to responding to this Expression of Interest and submitting a product for evaluation in Round 8, participants will be required:
Information concerning the programme and requirements for participation in Round 8 are provided in the documents below.
The list of annexes and forms includes:
- General information on programme and timelines
- Definition of a 'product' and 'lot' and product variations
- Requirements for resubmission: product list
- WHO standard confidentiality and material transfer agreement
For further details on the requirements for product inclusion, please write to: firstname.lastname@example.org
* Per Product: Payment 1: US$ 8000 for lab evaluation; Payment 2: US$ 4000 for dossier review; Payment 3 (upon satisfactory performance in lab evaluation and dossier assessment): US$ 8000 for manufacturer site inspection.