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

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, packaging and labelling of in vitro diagnostics (IVD) (which includes RDTs), complemented with a questionnaire based survey of RDT manufacturers and implementers. A summary of desirable RDT labelling characteristics was compiled, which was reviewed and discussed during a RBM Stakeholder consultation meeting and subsequently amended and refined by a dedicated task force consisting of country programme implementers, experts in RDT implementation, IVD regulatory experts and manufacturers. RESULTS: This process led to the development of consensus documents with a list of suggested terms and abbreviations as well as specifications for labelling of box, device packaging, cassettes, buffer bottle and accessories (lancets, alcohol swabs, transfer devices, desiccants). Emphasis was placed on durability (permanent printing or water-resistant labels), legibility (font size, letter type), comprehension (use of symbols) and ease of reference (e.g. place of labelling on the box or cassette packaging allowing quick oversight). A generic IFU template was developed, comprising background information, a template for procedure and reading/interpretation, a selection of appropriate references and a symbol key of internationally recognized symbols together with suggestions about appropriate lay-out, style and readability. CONCLUSIONS: The present document together with its additional files compiled proposes best practices in labelling and IFU for malaria RDTs. It is expected that compliance with these best practices will increase harmonization among the different malaria RDT products available on the market and improve their user-friendliness.

Preparedness for infectious threats: public-private partnership to develop an affordable vaccine for an emergent threat: the trivalent Neisseria meningitidis ACW135 polysaccharide vaccine.

With the emergence of epidemic Neisseria meningitidis W135 meningitis in Burkina Faso during early 2002, the public health community was faced with the challenge of providing access to an appropriate and affordable vaccine in time for the upcoming 2003 epidemic season. Recognizing the implications of the emergent threat, the World Health Organization developed a strategy, established a public-private partnership to provide the needed vaccine, and then ensured that a stockpile was available for future use. The trivalent N meningitidis ACW135 polysaccharide vaccine that resulted is now one of the primary tools for epidemic response in African meningitis belt countries. It will remain so for the foreseeable future and until appropriate and affordable conjugate vaccines become part of national immunization programs in the region.