title: Assessment of the knowledge of graphical symbols labelled on malaria rapid diagnostic tests in four international settings.
abstract: BACKGROUND
  Graphical symbols on in vitro diagnostics (IVD symbols) replace the need for text in different languages and are used on malaria rapid diagnostic tests (RDTs) marketed worldwide. The present study assessed the comprehension of IVD symbols labelled on malaria RDT kits among laboratory staff in four different countries.
  
  
  METHODS
  Participants (n = 293) in Belgium (n = 96), the Democratic Republic of the Congo (DRC, n = 87), Cambodia (n = 59) and Cuba (n = 51) were presented with an anonymous questionnaire with IVD symbols extracted from ISO 15223 and EN 980 presented as stand-alone symbols (n = 18) and in context (affixed on RDT packages, n = 16). Responses were open-ended and scored for correctness by local professionals.
  
  
  RESULTS
  Presented as stand-alone, three and five IVD symbols were correctly scored for comprehension by 67% and 50% of participants; when contextually presented, five and seven symbols reached the 67% and 50% correct score respectively. 'Batch code' scored best (correctly scored by 71.3% of participants when presented as stand-alone), 'Authorized representative in the European Community' scored worst (1.4% correct). Another six IVD symbols were scored correctly by less than 10% of participants: 'Do not reuse', 'In vitro diagnostic medical device', 'Sufficient for', 'Date of manufacture', 'Authorised representative in EC', and 'Do not use if package is damaged'. Participants in Belgium and Cuba both scored six symbols above the 67% criterion, participants from DRC and Cambodia scored only two and one symbols above this criterion. Low correct scores were observed for safety-related IVD symbols, such as for 'Biological Risk' (42.7%) and 'Do not reuse' (10.9%).
  
  
  CONCLUSIONS
  Comprehension of IVD symbols on RDTs among laboratory staff in four international settings was unsatisfactory. Administrative and outreach procedures should be undertaken to assure their acquaintance by end-users.
authors: Department of Clinical Sciences, Institute of Tropical Medicine, Unit of Tropical Laboratory Medicine, Nationalestraat 155, B 2000 Antwerp, Belgium.
authors: Veerle
authors: V
authors: Hermans
authors: Lianet
authors: L
authors: Monzote
authors: Björn
authors: B
authors: Van den Sande
authors: Pierre
authors: P
authors: Mukadi
authors: Thai
authors: T
authors: Sopheak
authors: Philippe
authors: P
authors: Gillet
authors: Jan
authors: J
authors: Jacobs
mesh_terms: D001530:Belgium; D002160:Cambodia; D003462:Cuba; D015023:Democratic Republic of the Congo; D003955:Diagnostic Tests, Routine; D005260:Female; D006282:Health Personnel; D006801:Humans; D008288:Malaria / Q000175:diagnosis*; D008297:Male; D011356:Product Labeling; D011361:Professional Competence / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires