title: Defining the next generation of Plasmodium vivax diagnostic tests for control and elimination: Target product profiles.
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.
authors.affiliation: FIND, Geneva, Switzerland.
authors.forename: Xavier C
authors.identifier: 0000-0001-8409-3678
authors.initials: XC
authors.lastname: Ding
authors.affiliation: Department of Communicable Diseases and Health Analysis, Pan American Health Organization/World Health Organization, Washington, DC, Unites States of America.
authors.forename: Maria Paz
authors.initials: MP
authors.lastname: Ade
authors.affiliation: Eijkman-Oxford Clinical Research Unit, Jakarta, Indonesia.|The Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
authors.forename: J Kevin
authors.initials: JK
authors.lastname: Baird
authors.affiliation: Australian Army Malaria Institute, Brisbane, Australia.
authors.forename: Qin
authors.initials: Q
authors.lastname: Cheng
authors.affiliation: Global Malaria Programme, World Health Organization, Geneva, Switzerland.
authors.forename: Jane
authors.initials: J
authors.lastname: Cunningham
authors.affiliation: Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.|World Wide Antimalarial Resistance Network, Churchill Hospital, Oxford, United Kingdom.
authors.forename: Mehul
authors.initials: M
authors.lastname: Dhorda
authors.affiliation: Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, United Kingdom.
authors.forename: Chris
authors.initials: C
authors.lastname: Drakeley
authors.affiliation: University of Basel, Basel, Switzerland.|Swiss Tropical and Public Health Institute, Basel, Switzerland.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Felger
authors.affiliation: Institute of Tropical Medicine Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.|Departamento de Ciencias Celulares y Moleculares, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Peru.
authors.forename: Dionicia
authors.initials: D
authors.lastname: Gamboa
authors.affiliation: RIKEN Center for Life Science Technologies, Division of Genomic Technologies, Yokohama, Japan.
authors.forename: Matthias
authors.initials: M
authors.lastname: Harbers
authors.affiliation: Caucaseco Scientific Research Center, Cali, Colombia.
authors.forename: Socrates
authors.initials: S
authors.lastname: Herrera
authors.affiliation: Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
authors.forename: Naomi
authors.initials: N
authors.lastname: Lucchi
authors.affiliation: ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.|Centro de Investigação em Saúde da Manhiça (CISM), Maputo, Mozambique.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Mayor
authors.affiliation: Population Health and Immunity Division, Walter and Eliza Hall Institute, Parkville, Australia.|Department of Parasites and Insect Vectors, Institut Pasteur, Paris, France.
authors.forename: Ivo
authors.initials: I
authors.lastname: Mueller
authors.affiliation: Mahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
authors.forename: Jetsumon
authors.initials: J
authors.lastname: Sattabongkot
authors.affiliation: Programme National de Lutte contre le Paludisme, Antananarivo, Madagascar.|University of Antananarivo, Antananarivo, Madagascar.
authors.forename: Arsène
authors.initials: A
authors.lastname: Ratsimbason
authors.affiliation: Centre for Biomedical Research, Burnet Institute, Melbourne, Victoria, Australia.|Department of Medicine, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Jack
authors.initials: J
authors.lastname: Richards
authors.affiliation: University of Basel, Basel, Switzerland.|Swiss Tropical and Public Health Institute, Basel, Switzerland.
authors.forename: Marcel
authors.initials: M
authors.lastname: Tanner
authors.affiliation: FIND, Geneva, Switzerland.
authors.forename: Iveth J
authors.initials: IJ
authors.lastname: González
mesh_terms: D003955:Diagnostic Tests, Routine; D006801:Humans; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000469:parasitology / Q000517:prevention & control; D016780:Malaria, Vivax / Q000175:diagnosis* / Q000469:parasitology / Q000517:prevention & control; D010963:Plasmodium falciparum / Q000302:isolation & purification*; D010966:Plasmodium vivax / Q000302:isolation & purification*; D019095:Point-of-Care Systems; D013045:Species Specificity