A review of the WHO malaria rapid diagnostic test product testing programme (2008-2018): performance, procurement and policy.

Autor: Cunningham J; World Health Organization (WHO), Global Malaria Programme, 20 Appia Avenue, 1211, Geneva, Switzerland. cunninghamj@who.int., Jones S; Independent Consultant, Bedford Hill, Balham, London, SW12 9HR, UK.; Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention (CDC), Bldg. 23, Room 10-169, 1600 Clifton Road, Mailstop D-67, Atlanta, GA, 30329, USA., Gatton ML; School of Public Health and Social Work, Queensland University of Technology (QUT), 2 George St, Brisbane, QLD, Australia., Barnwell JW; Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention (CDC), Atlanta, GA, 30329, USA., Cheng Q; Australian Defence Force Malaria and Infectious Disease Institute (ADFMIDI), Gallipoli Barracks Enoggera, 4051, Brisbane, Australia., Chiodini PL; Department of Clinical Parasitology, Hospital for Tropical Diseases (HTD), Mortimer Market Centre, Mortimer Market, Capper St, Fitzrovia, London, UK.; London School of Hygiene and Tropical Medicine (LSHTM), London, UK., Glenn J; Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention (CDC), Bldg. 23, Room 10-169, 1600 Clifton Road, Mailstop D-67, Atlanta, GA, 30329, USA., Incardona S; Foundation for Innovative New Diagnostics (FIND), Campus Biotech, Building B, Level 0, Chemin des Mines 9, 1202, Geneva, Switzerland., Kosack C; Médecins Sans Frontières (MSF), Plantage Middenlaan 14, 1018 DD, Amsterdam, The Netherlands., Luchavez J; Parasitology Department of the Research Institute of Tropical Medicine (RITM), 9002 Research Dr, Alabang, Muntinlupa, The Philippines., Menard D; Laboratoire d'Epidémiologie Moléculaire du Paludisme, Institut Pasteur du Cambodge, Monivong Boulevard, PO 983, Phnom Penh, Cambodia., Nhem S; Laboratoire d'Epidémiologie Moléculaire du Paludisme, Institut Pasteur du Cambodge, Monivong Boulevard, PO 983, Phnom Penh, Cambodia., Oyibo W; Department of Medical Microbiology and Parasitology, College of Medicine, University of Lagos (UL), Private Mail Bag 12003, Lagos, Nigeria., Rees-Channer RR; Department of Clinical Parasitology, Hospital for Tropical Diseases (HTD), Mortimer Market Centre, Mortimer Market, Capper St, Fitzrovia, London, UK.; Foundation for Innovative New Diagnostics (FIND), Campus Biotech, Building B, Level 0, Chemin des Mines 9, 1202, Geneva, Switzerland., Gonzalez I; Foundation for Innovative New Diagnostics (FIND), Campus Biotech, Building B, Level 0, Chemin des Mines 9, 1202, Geneva, Switzerland., Bell D; Foundation for Innovative New Diagnostics (FIND), Campus Biotech, Building B, Level 0, Chemin des Mines 9, 1202, Geneva, Switzerland.
Jazyk: angličtina
Zdroj: Malaria journal [Malar J] 2019 Dec 02; Vol. 18 (1), pp. 387. Date of Electronic Publication: 2019 Dec 02.
DOI: 10.1186/s12936-019-3028-z
Abstrakt: Malaria rapid diagnostic tests (RDTs) emerged in the early 1990s into largely unregulated markets, and uncertain field performance was a major concern for the acceptance of tests for malaria case management. This, combined with the need to guide procurement decisions of UN agencies and WHO Member States, led to the creation of an independent, internationally coordinated RDT evaluation programme aiming to provide comparative performance data of commercially available RDTs. Products were assessed against Plasmodium falciparum and Plasmodium vivax samples diluted to two densities, along with malaria-negative samples from healthy individuals, and from people with immunological abnormalities or non-malarial infections. Three measures were established as indicators of performance, (i) panel detection score (PDS) determined against low density panels prepared from P. falciparum and P. vivax wild-type samples, (ii) false positive rate, and (iii) invalid rate, and minimum criteria defined. Over eight rounds of the programme, 332 products were tested. Between Rounds 1 and 8, substantial improvements were seen in all performance measures. The number of products meeting all criteria increased from 26.8% (11/41) in Round 1, to 79.4% (27/34) in Round 8. While products submitted to further evaluation rounds under compulsory re-testing did not show improvement, those voluntarily resubmitted showed significant increases in P. falciparum (p = 0.002) and P. vivax PDS (p < 0.001), with more products meeting the criteria upon re-testing. Through this programme, the differentiation of products based on comparative performance, combined with policy changes has been influential in the acceptance of malaria RDTs as a case-management tool, enabling a policy of parasite-based diagnosis prior to treatment. Publication of product testing results has produced a transparent market allowing users and procurers to clearly identify appropriate products for their situation, and could form a model for introduction of other, broad-scale diagnostics.
Databáze: MEDLINE
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