title: 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, 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.
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium. jjacobs@itg.be.
authors.forename: Jan
authors.initials: J
authors.lastname: Jacobs
authors.forename: Barbara
authors.initials: B
authors.lastname: Barbé
authors.forename: Philippe
authors.initials: P
authors.lastname: Gillet
authors.forename: Michael
authors.initials: M
authors.lastname: Aidoo
authors.forename: Elisa
authors.initials: E
authors.lastname: Serra-Casas
authors.forename: Jan
authors.initials: J
authors.lastname: Van Erps
authors.forename: Joelle
authors.initials: J
authors.lastname: Daviaud
authors.forename: Sandra
authors.initials: S
authors.lastname: Incardona
authors.forename: Jane
authors.initials: J
authors.lastname: Cunningham
authors.forename: Theodoor
authors.initials: T
authors.lastname: Visser
mesh_terms: D003955:Diagnostic Tests, Routine / Q000379:methods*; D006801:Humans; D008288:Malaria / Q000175:diagnosis*; D017410:Practice Guidelines as Topic; D011356:Product Labeling / Q000592:standards*