Initiative for quality assurance of malaria rapid diagnostic tests: Outline of product testing and associated protocols (archived)
This document provides an overview of the product testing scheme for antigen-detecting malaria rapid diagnostic tests under the WHO – FIND Malaria RDT Evaluation Programme. It describes the composition, characterization and management of the specimen bank, the protocols for product testing and use of product testing results, as well as the evidence and methods on which the specimen bank and protocols are based. The evaluation described provides performance data against a panel designed to mimic natural infections as closely as possible while fulfilling the necessity for standardization of testing. It is not, therefore, intended to fully replace field testing of RDTs.