title: Self-diagnosis of malaria by travelers and expatriates: assessment of malaria rapid diagnostic tests available on the internet.
abstract: BACKGROUND
  In the past malaria rapid diagnostic tests (RDTs) for self-diagnosis by travelers were considered suboptimal due to poor performance. Nowadays RDTs for self-diagnosis are marketed and available through the internet. The present study assessed RDT products marketed for self-diagnosis for diagnostic accuracy and quality of labeling, content and instructions for use (IFU).
  
  
  METHODS
  Diagnostic accuracy of eight RDT products was assessed with a panel of stored whole blood samples comprising the four Plasmodium species (n = 90) as well as Plasmodium negative samples (n = 10). IFUs were assessed for quality of description of procedure and interpretation and for lay-out and readability level. Errors in packaging and content were recorded.
  
  
  RESULTS
  Two products gave false-positive test lines in 70% and 80% of Plasmodium negative samples, precluding their use. Of the remaining products, 4/6 had good to excellent sensitivity for the diagnosis of Plasmodium falciparum (98.2%-100.0%) and Plasmodium vivax (93.3%-100.0%). Sensitivity for Plasmodium ovale and Plasmodium malariae diagnosis was poor (6.7%-80.0%). All but one product yielded false-positive test lines after reading beyond the recommended reading time. Problems with labeling (not specifying target antigens (n = 3), and content (desiccant with no humidity indicator (n = 6)) were observed. IFUs had major shortcomings in description of test procedure and interpretation, poor readability and lay-out and user-unfriendly typography. Strategic issues (e.g. the need for repeat testing and reasons for false-negative tests) were not addressed in any of the IFUs.
  
  
  CONCLUSIONS
  Diagnostic accuracy of RDTs for self-diagnosis was variable, with only 4/8 RDT products being reliable for the diagnosis of P. falciparum and P. vivax, and none for P. ovale and P. malariae. RDTs for self-diagnosis need improvements in IFUs (content and user-friendliness), labeling and content before they can be considered for self-diagnosis by the traveler.
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium. jmaltha@itg.be
authors.forename: Jessica
authors.initials: J
authors.lastname: Maltha
authors.forename: Philippe
authors.initials: P
authors.lastname: Gillet
authors.forename: Marloes
authors.initials: M
authors.lastname: Heutmekers
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Bottieau
authors.forename: Alfons
authors.initials: A
authors.lastname: Van Gompel
authors.forename: Jan
authors.initials: J
authors.lastname: Jacobs
mesh_terms: D059026:Diagnostic Self Evaluation; D005189:False Positive Reactions; D006801:Humans; D020407:Internet; D008288:Malaria / Q000175:diagnosis*; D015233:Models, Statistical; D015588:Observer Variation; D010963:Plasmodium falciparum / Q000302:isolation & purification*; D010965:Plasmodium malariae / Q000302:isolation & purification; D041122:Plasmodium ovale / Q000302:isolation & purification; D010966:Plasmodium vivax / Q000302:isolation & purification*; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D014195:Travel
chemical_list: D011933:Reagent Kits, Diagnostic