Abstract
IntroductionIn 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).MethodsDiagnostic 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.ResultsTwo 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.ConclusionDiagnostic 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.
Highlights
In the past malaria rapid diagnostic tests (RDTs) for self-diagnosis by travelers were considered suboptimal due to poor performance
RDT Selection During the internet search eight RDT products were encountered and ordered. Three of these products were not included in the final selection: one (Malapack Travel test, http://www. vaccinations.com.au/product.htm) was not marketed anymore, the manufacturer of the second product (EZ-Trust Malaria Rapid Screen Test Kit, CS Innovation Pte Ltd, Singapore) replied not to start up the production for an order less than 10,000 tests
For 6/8 RDT products 100% sensitivity was reached for P. falciparum diagnosis, but Labstix and Onestep showed false positive lines in respectively 80% and 70% of malaria negative samples
Summary
In the past malaria rapid diagnostic tests (RDTs) for self-diagnosis by travelers were considered suboptimal due to poor performance. The present study assessed RDT products marketed for self-diagnosis for diagnostic accuracy and quality of labeling, content and instructions for use (IFU). In the SBET strategy, travelers and expatriates to low-resource endemic settings carry an emergency malaria treatment (with reliable activity against P. falciparum) for self-administration when no medical attention is rapidly available. This option may be considered where the risk of adverse reaction to malaria chemoprophylaxis outweighs the risk of malaria infection [7,8] and is increasingly promoted by some experts in travel medicine [9]. Self-diagnosis of febrile illness with reliable malaria RDTs could accelerate early therapy (with the standby treatment), preventing complications and death, or avoid unnecessary use of antimalarials [10,11]
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