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




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Introduction

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.



Author: Jessica Maltha , Philippe Gillet, Marloes Heutmekers, Emmanuel Bottieau, Alfons Van Gompel, Jan Jacobs

Source: http://plos.srce.hr/



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