Harmonization of malaria rapid diagnostic tests: best practices in labelling including instructions for use.

ABSTRACT:

Background

Rapid diagnostic tests (RDTs) largely account for the scale-up of malaria diagnosis in endemic settings. However, diversity in labelling including the instructions for use (IFU) limits their interchangeability and user-friendliness. Uniform, easy to follow and consistent labelling, aligned with international standards and appropriate for the level of the end user's education and training, is crucial but a consolidated resource of information regarding best practices for IFU and labelling of RDT devices, packaging and accessories is not available.

Methods

The Roll Back Malaria Partnership (RBM) commissioned the compilation of international standards and regulatory documents and published literature containing specifications and/or recommendations for RDT design, pa

SUBMITTER: Jacobs J 

PROVIDER: S-EPMC4302121 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature