title: Assessment of desiccants and their instructions for use in rapid diagnostic tests.
abstract: BACKGROUND
  Malaria rapid diagnostic tests (RDTs) are protected from humidity-caused degradation by a desiccant added to the device packaging. The present study assessed malaria RDT products for the availability, type and design of desiccants and their information supplied in the instructions for use (IFU).
  
  
  METHODS
  Criteria were based on recommendations of the World Health Organization (WHO), the European Community (CE) and own observations. Silica gel sachets were defined as self-indicating (all beads coated with a humidity indicator that changes colour upon saturation), partial-indicating (part of beads coated) and non-indicating (none of the beads coated). Indicating silica gel sachets were individually assessed for humidity saturation and (in case of partial-indicating silica gels) for the presence of indicating beads.
  
  
  RESULTS
  Fifty malaria RDT products from 25 manufacturers were assessed, 14 (28%) products were listed by the "Global Fund Quality Assurance Policy" and 31 (62%) were CE-marked. All but one product contained a desiccant, mostly (47/50, 94%) silica gel. Twenty (40%) RDT products (one with no desiccant and 19 with non-indicating desiccant) did not meet the WHO guidelines recommending indicating desiccant. All RDT products with self- or partial-indicating silica gel (n = 22 and 8 respectively) contained the toxic cobalt dichloride as humidity indicator. Colour change indicating humidity saturation was observed for 8/16 RDT products, at a median incidence of 0.8% (range 0.05%-4.6%) of sachets inspected. In all RDTs with partial-indicating silica gel, sachets with no colour indicating beads were found (median proportion 13.5% (0.6%-17.8%) per product) and additional light was needed to assess the humidity colour. Less than half (14/30, 47%) IFUs of RDT products with indicating desiccants mentioned to check the humidity saturation before using the test. Information on properties, safety hazards and disposal of the desiccant was not included in any of the IFUs. There were no differences between Global Fund-listed and CE marked RDT products compared to those which were not. Similar findings were noted for a panel of 11 HIV RDTs that was assessed with the same checklist as the malaria RDTs.
  
  
  CONCLUSIONS
  RDTs showed shortcomings in desiccant type and information supplied in the IFU.
authors.affiliation: Unit of Tropical Laboratory Medicine, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Barbara
authors.initials: B
authors.lastname: Barbé
authors.forename: Philippe
authors.initials: P
authors.lastname: Gillet
authors.forename: Greet
authors.initials: G
authors.lastname: Beelaert
authors.forename: Katrien
authors.initials: K
authors.lastname: Fransen
authors.forename: Jan
authors.initials: J
authors.lastname: Jacobs
mesh_terms: D003955:Diagnostic Tests, Routine / Q000379:methods / Q000592:standards*; D019983:Guideline Adherence; D006302:Health Services Research; D006801:Humans; D058427:Hygroscopic Agents / Q000494:pharmacology*; D008288:Malaria / Q000175:diagnosis*; D011356:Product Labeling
chemical_list: D058427:Hygroscopic Agents