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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.    Conclusion  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.

Self-Diagnosis of Malaria by Travelers and Expatriates: Assessment of Malaria Rapid Diagnostic Tests Available on the Internet