6.5. Quality control and quality assurance

To guarantee inter-batch reproducibility and optimal performance of marketed RDT kits, production standards (good manufacturing practices) should be provided and followed. Standard reagents, such as positive controls, should be made available for quality control. The provision of standards for quality control and the management of a reference reagent bank are functions best performed by an agency such as WHO. An additional role for such a coordinating body would be to co-ordinate the production and distribution of antigen or antibody reagents. This could facilitate test development and decrease costs since 40-50% of the cost of manufacturing RDT kits may be attributable to the monoclonal antibodies. Such an arrangement, however, would need to be carried out under agreements that do not inhibit the development of improved assays.