Malaria

Changes to the WHO-FIND Malaria RDT Lot Testing Programme

29 November 2017

This information note replaces the earlier note on the malaria RDT lot testing programme issued on 6 November 2017. The pilot implementation of decentralized malaria RDT lot testing has been postponed due to insufficient financial resources. The current model of lot testing will continue with some modifications described below.

Background

For the last 9 years, FIND and WHO have coordinated an independent global quality assessment programme for malaria rapid diagnostic test (RDT) lots. The programme was funded initially by the Bill and Melinda Gates Foundation and the Global Fund to Fight AIDS, Tuberculosis and Malaria, and over the last 5 years, has been supported by UNITAID and USAID/JSI.

The programme is designed to assess lot-to-lot variations in RDT performance in order to ensure that only malaria RDT lots that meet performance standards are used in endemic countries. Since 2011, lot testing has been mandatory for all Global Fund grant recipients and has been adopted by all other major RDT procurers.

From 2007 through 2016, the WHO-FIND global lot testing programme tested more than 5000 RDT lots (representing over 900 million RDTs) destined for more than 70 endemic countries. The testing has been conducted free of charge for health ministries, malaria control programmes, RDT procurers, implementing organizations and RDT manufacturers, using reference laboratories in Cambodia (Institut Pasteur [IPC]) and the Philippines (Research Institute for Tropical Medicine [RITM]).

Malaria RDT Lot Testing: modification of procedures

Effective 5 December 2017, the Foundation for Innovative New Diagnostics (FIND) and the Institute Pasteur (IPC) will no longer be involved in the coordination or conduct of the international malaria RDT lot testing scheme. However, the Research Institute for Tropical Medicine (RITM) will continue to operate as the lot testing laboratory serving the global community and WHO will coordinate lot testing activities. The standard WHO-FIND lot testing protocols will be followed with minor revisions.

Steps for submission

i) All requests for lot testing should be made by sending the form below to: Malaria_rdt@who.int

ii) All shipments should be directed to the Research Institute for Tropical Medicine (RITM), in the Philippines.1 Taxes and duties should be pre-paid and a copy of the lot testing request form should be inserted in one of the boxes with the RDTs.

Research Institute for Tropical Medicine
WHO Collaborating Centre
Filinvest Compound Alabang
Muntinlupa City Philippines
Tel. +632-8072628-32 local 227
Attn. Christian Anthony B Luna and Jennifer Luchavez

iii) Due to the increased workload at RITM in the short term, there may be delays before results are issued. Results will be provided in 7 working days from receipt of the RDTs at RITM.

iv) Services will continue to be free of charge at RITM.

WHO will continue efforts to mobilize resources and to review options to support the pilot project of partially decentralized lot testing using malaria recombinant antigen panels in national reference laboratories. Further updates on the pilot lot testing scheme can be expected by mid-2018.

Information

Please do not hesitate to contact WHO should you require more information about this transition.

Contact person: Jane A Cunningham


Notes:
1 WHO has commissioned annual independent, external quality laboratory assessments of the National Institute of Malaria Research (NIMR), New Delhi, India and the ANDI Centre of Excellence for Malaria Diagnosis, University of Lagos, Nigeria and these laboratories are compliant with WHO malaria RDT lot testing standard operating procedures. These laboratories will be conducting lot verification for RDT batches imported into their respective countries.