Cher(e)s collègues,
Dans un article récemment publié dans le Malaria Journal, Jan Jacobs et al. décrivent une compilation des standards internationales, documents de règlementation et littérature scientifique concernant les spécifications et recommandations pour la conception, conditionnement et étiquetage des diagnostics in vitro pour le paludisme (ceux-ci incluent les tests diagnostiques rapides). La compilation a été commissionnée par le Roll Back Malaria Partnership. Elle contient un résumé des caractéristiques souhaitables pour l’étiquetage des tests diagnostiques rapides, qui peut être bien intéressant aussi dans le cadre d’autres pathologies tropicales. L’article peut être lu dans le site web du Malaria Journal :
http://www.malariajournal.com/content/13/1/505
L’abstract en anglais est copiée ci-dessous.
Amicalement,
Raffaella Ravinetto
Institut de Médicine Tropicale
Anvers, Belgique
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.
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