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

Ding XC; Ade MP; Baird JK; Cheng Q; Cunningham J; Dhorda M; Drakeley C; Felger I; Gamboa D; Harbers M; Herrera S; Lucchi N; Mayor A; Mueller I; Sattabongkot J; Ratsimbason A; Richards J; Tanner M; González IJ

doi:10.1371/journal.pntd.0005516

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Journal article

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

Ding XC FIND, Geneva, Switzerland.
Ade MP Department of Communicable Diseases and Health Analysis, Pan American Health Organization/World Health Organization, Washington, DC, Unites States of America.
Baird JK Eijkman-Oxford Clinical Research Unit, Jakarta, Indonesia.
Cheng Q Australian Army Malaria Institute, Brisbane, Australia.
Cunningham J Global Malaria Programme, World Health Organization, Geneva, Switzerland.
Dhorda M Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Drakeley C Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Felger I University of Basel, Basel, Switzerland.
Gamboa D Institute of Tropical Medicine Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
Harbers M RIKEN Center for Life Science Technologies, Division of Genomic Technologies, Yokohama, Japan.
Herrera S Caucaseco Scientific Research Center, Cali, Colombia.
Lucchi N Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
Mayor A ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.
Mueller I Population Health and Immunity Division, Walter and Eliza Hall Institute, Parkville, Australia.
Sattabongkot J Mahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Ratsimbason A Programme National de Lutte contre le Paludisme, Antananarivo, Madagascar.
Richards J Centre for Biomedical Research, Burnet Institute, Melbourne, Victoria, Australia.
Tanner M University of Basel, Basel, Switzerland.
González IJ FIND, Geneva, Switzerland.

2017-04-04

Published in:

PLoS neglected tropical diseases. - 2017

English 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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