Self-diagnosis of malaria by travelers and expatriates: assessment of malaria rapid diagnostic tests available on the internet

J. Maltha, P. Gillet, M. Heutmekers, E. Bottieau, A. Van Gompel, J. Jacobs

Research output: Contribution to journalA1: Web of Science-article

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Abstract

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.
Original languageEnglish
JournalPLoS ONE
Volume8
Issue number1
Pages (from-to)e53102
ISSN1932-6203
DOIs
Publication statusPublished - 2013

Keywords

  • Protozoal diseases
  • Malaria
  • Plasmodium falciparum
  • Plasmodium vivax
  • Plasmodium ovale
  • Plasmodium malariae
  • Vectors
  • Mosquitoes
  • Anopheles
  • Diagnosis
  • Rapid diagnostic tests
  • Health care seeking behavior
  • Travelers
  • Availability
  • Internet
  • Assessment
  • Accuracy
  • Quality control
  • Labeling
  • Reliability

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