title: Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts.
abstract: BACKGROUND
  The present study assessed malaria RDT kits for adequate and correct packaging, design and labelling of boxes and components. Information inserts were studied for readability and accuracy of information.
  
  
  METHODS
  Criteria for packaging, design, labelling and information were compiled from Directive 98/79 of the European Community (EC), relevant World Health Organization (WHO) documents and studies on end-users' performance of RDTs. Typography and readability level (Flesch-Kincaid grade level) were assessed.
  
  
  RESULTS
  Forty-two RDT kits from 22 manufacturers were assessed, 35 of which had evidence of good manufacturing practice according to available information (i.e. CE-label affixed or inclusion in the WHO list of ISO13485:2003 certified manufacturers). Shortcomings in devices were (i) insufficient place for writing sample identification (n=40) and (ii) ambiguous labelling of the reading window (n=6). Buffer vial labels were lacking essential information (n=24) or were of poor quality (n=16). Information inserts had elevated readability levels (median Flesch Kincaid grade 8.9, range 7.1-12.9) and user-unfriendly typography (median font size 8, range 5-10). Inadequacies included (i) no referral to biosafety (n=18), (ii) critical differences between depicted and real devices (n=8), (iii) figures with unrealistic colours (n=4), (iv) incomplete information about RDT line interpretations (n=31) and no data on test characteristics (n=8). Other problems included (i) kit names that referred to Plasmodium vivax although targeting a pan-species Plasmodium antigen (n=4), (ii) not stating the identity of the pan-species antigen (n=2) and (iii) slight but numerous differences in names displayed on boxes, device packages and information inserts. Three CE labelled RDT kits produced outside the EC had no authorized representative affixed and the shape and relative dimensions of the CE symbol affixed did not comply with the Directive 98/79/EC. Overall, RDTs with evidence of GMP scored better compared to those without but inadequacies were observed in both groups.
  
  
  CONCLUSIONS
  Overall, malaria RDTs showed shortcomings in quality of construction, design and labelling of boxes, device packages, devices and buffers. Information inserts were difficult to read and lacked relevant information.
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine (ITM), Unit of Tropical Laboratory Medicine, Nationalestraat 155, B 2000 Antwerp, Belgium. pgillet@itg.be
authors.forename: Philippe
authors.initials: P
authors.lastname: Gillet
authors.forename: Jessica
authors.initials: J
authors.lastname: Maltha
authors.forename: Veerle
authors.initials: V
authors.lastname: Hermans
authors.forename: Raffaella
authors.initials: R
authors.lastname: Ravinetto
authors.forename: Cathrien
authors.initials: C
authors.lastname: Bruggeman
authors.forename: Jan
authors.initials: J
authors.lastname: Jacobs
mesh_terms: D003955:Diagnostic Tests, Routine / Q000379:methods / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D008288:Malaria / Q000175:diagnosis*; D019064:Product Packaging / Q000592:standards*; D011785:Quality Assurance, Health Care; D011933:Reagent Kits, Diagnostic / Q000592:standards*
chemical_list: D011933:Reagent Kits, Diagnostic