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Defining the next generation of Plasmodium vivax diagnostic tests for control and elimination: Target product profiles

X.C. Ding 1, * M.P. Ade 2 J.K. Baird 3 Qin Cheng 4 Jane Cunningham 5 Mehul Dhorda 6, 7 Chris Drakeley 8 Ingrid Felger 9 Dionicia Gamboa 10 Matthias Harbers 11 Socrates Herrera 12 Naomi Lucchi 13 Alfredo Mayor 14 Ivo Mueller 15, 16 Jetsumon Sattabongkot 17 Arsène Ratsimbason 18 Jack Richards 19, 20 Marcel Tanner 21, 9 I.J. González 22
Abstract : The global prevalence of malaria has decreased over the past fifteen years, but similar gains have not been realized against Plasmodium vivax because this species is less responsive to conventional malaria control interventions aimed principally at P. falciparum. Approximately half of all malaria cases outside of Africa are caused by P. vivax. This species places dormant forms in human liver that cause repeated clinical attacks without involving another mosquito bite. The diagnosis of acute patent P. vivax malaria relies primarily on light microscopy. Specific rapid diagnostic tests exist but typically perform relatively poorly compared to those for P. falciparum. Better diagnostic tests are needed for P. vivax. To guide their development, FIND, in collaboration with P. vivax experts, identified the specific diagnostic needs associated with this species and defined a series of three distinct target product profiles, each aimed at a particular diagnostic application: (i) point-of-care of acutely ill patients for clinical care purposes; (ii) point-of-care asymptomatic and otherwise sub-patent residents for public health purposes, e.g., mass screen and treat campaigns; and (iii) ultra-sensitive not point-of-care diagnosis for epidemiological research/surveillance purposes. This report presents and discusses the rationale for these P. vivax-specific diagnostic target product profiles. These contribute to the rational development of fit-for-purpose diagnostic tests suitable for the clinical management, control and elimination of P. vivax malaria.
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Submitted on : Friday, July 28, 2017 - 4:21:15 PM
Last modification on : Thursday, December 17, 2020 - 3:06:57 AM

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X.C. Ding, M.P. Ade, J.K. Baird, Qin Cheng, Jane Cunningham, et al.. Defining the next generation of Plasmodium vivax diagnostic tests for control and elimination: Target product profiles. PLoS Neglected Tropical Diseases, Public Library of Science, 2017, 11 (4), pp.e0005516. ⟨10.1371/journal.pntd.0005516⟩. ⟨pasteur-01570234⟩

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