1. Defining the next generation of Plasmodium vivax diagnostic tests for control and elimination: Target product profiles
- Author
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Naomi W. Lucchi, Jack S. Richards, Xavier C. Ding, Maria Paz Ade, Arsène Ratsimbason, Sócrates Herrera, Mehul Dhorda, Iveth J. González, Ivo Mueller, Jetsumon Sattabongkot, Alfredo Mayor, Jane Cunningham, Marcel Tanner, Matthias Harbers, Chris Drakeley, Dionicia Gamboa, Ingrid Felger, Qin Cheng, J. Kevin Baird, Foundation for Innovative New Diagnostics (FIND), Pan American Health Organization, World Health Organization (PANAFTOSA), Eijkman Institute for Molecular Biology [Jakarta], Australian Army Malaria Institute, Global Malaria Programme, Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), University of Oxford, Churchill Hospital [Breast Care Unit], Churchill Hospital Oxford Centre for Haematology, London School of Hygiene and Tropical Medicine (LSHTM), Swiss Tropical and Public Health Institute [Basel], Universidad Peruana Cayetano Heredia (UPCH), RIKEN Center for Life Science Technologies (RIKEN CLST), RIKEN - Institute of Physical and Chemical Research [Japon] (RIKEN), Caucaseco scientific research center = Centro de Investigación Científica Caucaseco, Centers for Disease Control and Prevention [Atlanta] (CDC), Centers for Disease Control and Prevention, Barcelona Centre for International Health Research, Hospital Clinic (CRESIB), Universitat de Barcelona (UB), The Walter and Eliza Hall Institute of Medical Research (WEHI), Département Parasites et Insectes vecteurs - Department of Parasites and Insect Vectors, Institut Pasteur [Paris] (IP), Mahidol University [Bangkok], Université d'Antananarivo, Burnet Institute [Melbourne, Victoria], University of Melbourne, University of Basel (Unibas), This work was supported by funds from the Department of Foreign Affairs and Trade, Australian Government., University of Oxford [Oxford], and Institut Pasteur [Paris]
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Plasmodium ,Physiology ,Plasmodium vivax ,Psychological intervention ,Plasmodium vivax/isolation & purification ,0302 clinical medicine ,[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,Epidemiology ,Medicine and Health Sciences ,030212 general & internal medicine ,Malaria, Falciparum ,MESH: Plasmodium falciparum ,Protozoans ,biology ,lcsh:Public aspects of medicine ,MESH: Malaria, Falciparum ,Malarial Parasites ,Parasitic diseases ,3. Good health ,MESH: Plasmodium vivax ,MESH: Point-of-Care Systems ,Body Fluids ,Malalties parasitàries ,[SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology ,Blood ,Infectious Diseases ,Malaria, Vivax/diagnosis/parasitology/prevention & control ,Anatomy ,purl.org/pe-repo/ocde/ford#3.03.06 [https] ,Research Article ,medicine.medical_specialty ,lcsh:Arctic medicine. Tropical medicine ,Infectious Disease Control ,lcsh:RC955-962 ,Point-of-Care Systems ,030231 tropical medicine ,Plasmodium falciparum ,03 medical and health sciences ,Species Specificity ,Diagnostic Medicine ,parasitic diseases ,Parasite Groups ,medicine ,Gametocyte ,Malaria, Vivax ,Parasitic Diseases ,MESH: Species Specificity ,Humans ,Malaria, Falciparum/diagnosis/parasitology/prevention & control ,Intensive care medicine ,MESH: Diagnostic Tests, Routine ,MESH: Humans ,Plasmodium falciparum/isolation & purification ,Diagnostic Tests, Routine ,Public health ,Public Health, Environmental and Occupational Health ,Organisms ,MESH: Malaria, Vivax ,Biology and Life Sciences ,lcsh:RA1-1270 ,medicine.disease ,biology.organism_classification ,Tropical Diseases ,Parasitic Protozoans ,Malaria ,Parasitology ,Immunology ,Apicomplexa - 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., Author summary Plasmodium vivax is the second most prevalent Plasmodium species amongst the five that can infect humans and cause malaria. The control and elimination of P. vivax is complicated by its specific biology, such as hard-to-detect low densities of blood-circulating parasites in infected individuals, the existence of persistent liver forms causing relapse, or the early appearance of sexual stages of the parasite during the course of an infection, which facilitates its transmission. These difficulties are reinforced by the fact that most antimalarial tools have been developed primarily for P. falciparum, the most prevalent malaria species, and are not always as effective for P. vivax. Current tools for the diagnosis of P. vivax are of limited effectiveness. Rapid diagnostic tests exist but show, in average, lower performance than similar test for P. falciparum. P. vivax diagnosis often relies on light microscopy which is challenging to maintain at a high quality and not sensitive enough to detect a large fraction of all infections. Recognizing that better diagnostic tools for P. vivax are needed, we report in this study the development of new target product profiles to define the specific characteristics of such tests. The establishment of these consensus-based documents is an important first step to guide research and development efforts toward better diagnostic solutions for P. vivax malaria and to accelerate the elimination of this species alongside P. falciparum.
- Published
- 2016
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