We have been receiving applications from several manufacturers of malaria RDTs, either as new product applications or as Change Requests, regarding the inclusion single-test configurations in their products.
For some time WHO PQ has taken the approach that there is a risk that such configurations could be misused in self testing. As a result, we have not considered these product configurations as being eligible for PQ assessment.
WHO PQ has reviewed its position regarding these product configurations and how the risk of misuse can be managed.WHO PQ wishes to advise manufacturers that single-test configurations of malaria RDTs are now eligible for PQ assessment, provided that all product labelling (IFU, packaging, and component labels) makes clear that the product must not be used as a self-test.
Manufactures of new products that include single-test configurations are invited to submit an application for assessment of their malaria RDT. Manufacturers who wish to add such configurations to their already listed product may do so by submitting an Change Request application.