RDT Evaluation Programme

Lot testing: Pre- and Post-purchase

It is recommended that all lots (batches) of RDTs be tested before deployment to the field. A 'lot' to be tested is normally defined as a production run using a particular batch of monoclonal antibodies and nitrocellulose. They are normally defined by number in this way by the manufacturer, and usually consist of 40000 to 80000 tests. Lot testing can be done:
(1) before purchase, directly arranged with the manufacturer and a lot-testing centre (note: WHO WebBuy can not arrange this)
(2) after purchase, before distribution to the field (more common).

Why lot-test?

  • Lot-lot variation noted in most products
  • Ensure no damage during transport to country
  • Need to convince clinicians / users / regulatory authorities that tests are working

Lot-testing is readily accessible now

Lot-testing capacity has been developed through a joint programme of the WHO and the Foundation for Innovative New Diagnostics (FIND), and can be facilitated by WHO. It is currently performed at lot-testing centres in the Western Pacific Region which can test for programmes globally, and capacity is currently being developed in Africa (Ethiopia). WHO and FIND will provide information on further lot testing laboratories with full contact details as soon as they will become fully operational.


Requesting Lot testing

*** IMPORTANT NOTICE ***
CHANGES TO LOT TESTING PROCEDURES
HYPER LINK TO THE PDF ATTACHED : CHANGES TO LOT-TESTING PROTOCOL AUGUST 2011.PDF

Requests for more information related to lot-testing should be made by sending the attached Malaria RDT Request Form to WHO/FIND at:  malaria_rdt@who.int and

Lot-testing is currently conducted through the WHO-FIND network at no charge, but the sending institution covers transport costs. At least 2 weeks prior notice should be given before to arrange for testing.

Testing is performed on a sample of about 125 P. falciparum-only RDTs or 175 combined P. falciparum and pan-specific RDTs, for each production lot in the order. The lot-testing centres follow procedures developed by WHO for this purpose , and usually return initial results within five (5) working days. Retained RDTs are then monitored every six (6) months throughout the shelf-life at close to the manufacturer's recommended maximum storage temperature, and the procuring agency informed of results throughout the shelf-life (Example Report Form). The procedures followed by laboratories contracted by WHO and FIND for this purpose are found in the Methods Manual for Laboratory Control Testing of Malaria Rapid Diagnostic tests


Lot testing results (2007-2009)

Lot testing results (2007-2009)
 

Lot Testing of Malaria Rapid Diagnostic Tests brochure

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