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Table 1 Number of RDTs (n = 42) with inadequacies in malaria RDT boxes, device packages, devices, buffer vials and package inserts*

From: Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts

Items considered to be inadequate Number (%)
Box: construction and design  
  Materials: plastic bag or simple cardboard (not humidity-resistant) 9 (21.4)
  No labels, no printed information or labels not humidity-resistant 6 (14.3)
  Differences in name on device packaging, device, buffer and information insert 27 (64.3)
Box: information displayed  
  No EC-REP mentioned on CE labelled RDTs, although required (n = 25) 3 (12.0)
  RDT kit's name nor additional information refer to intended use 3 (7.1)
  RDT kit's name incorrectly refers to P. vivax instead of non-falciparum species (n = 29) 4 (13.8)
  Kit components not displayed 26 (62%)
  Essential information lacking: expiry date, numbers of tests included, storage conditions 12 (28.6)
Kit contents:  
  Capillary sampling system (lancet and alcohol swap) not included or not optionally included 24 (57%)
  Blood transfer system (capillary, pipette or tube) not included 3 (7.1%)
Device package and content: construction and design  
  Material not humidity-resistant 4 (9.5)
  No desiccant or desiccant without saturation indicator 18 (42.9)
Device package and content: information displayed  
  Essential information lacking: expiry date, lot number, test kit name 9 (21.4)
  No warning label "do not swallow" on desiccant 6 (14.3)
Device: construction and design  
  Space for sample identification too small or not writable with standard pen (felt pen needed) 40 (95.2)
  No or incomplete RDT name on the device 29 (69.0)
  No reading label or simultaneous presence two reading labels consisting of symbols only 6 (14.3)
Buffer: construction and design  
  Buffer vial not leak proof 2 (4.8)
  Label does not stick well to the vial, prints are not humidity-resistant (n = 40) 16 (40.0)
Buffer: information displayed  
  Essential information lacking: expiry date, lot number, storage conditions, correct RDT kit's name (n = 41) 24 (58.5)
  No instructions included on how to pierce the buffer vial dropper (n = 15) 5 (33.3)
Package insert: information  
  Absence of date of release or version number 20 (47.6)
Package insert: content  
  Identity of target antigens not clearly mentioned 2 (4.8)
  No referral to biosafety precautions (gloves, safe waste disposal, etc.) 18 (42.9)
  Major differences between depicted and real device (n = 40) 8 (20.0)
  Use of figures with unrealistic colours (e.g. control and test lines depicted as green) 4 (9.5)
  No data on test characteristics (sensitivity, specificity) 8 (19.0)
  1. * Total number of RDT kits = 42 unless otherwise stated.