Global survey of malaria rapid diagnostic test (RDT) sales, procurement and lot verification practices: assessing the use of the WHO–FIND Malaria RDT Evaluation Programme (2011–2014)

• Published in: Malaria Journal
• Main Authors: Sandra Incardona, Elisa Serra-Casas, Nora Champouillon, Christian Nsanzabana, Jane Cunningham, Iveth J. González
• Format: Article in Journal/Newspaper
• Language: English
• Published: BMC 2017
• Subjects: Malaria; Rapid diagnostic test; Quality control; Product testing; Lot testing; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic
• Online Access: https://doi.org/10.1186/s12936-017-1850-8; https://doaj.org/article/4d4feec2571748d5aa5ed782b62e4270

Abstract Background Malaria rapid diagnostic tests (RDTs) play a critical role in malaria case management, and assurance of quality is a key factor to promote good adherence to test results. Since 2007, the World Health Organization (WHO) and the Foundation for Innovative New Diagnostics (FIND) have coordinated a Malaria RDT Evaluation Programme, comprising a pre-purchase performance evaluation (product testing, PT) and a pre-distribution quality control of lots (lot testing, LT), the former being the basis of WHO recommendations for RDT procurement. Comprehensive information on malaria RDTs sold worldwide based on manufacturers’ data and linked to independent performance data is currently not available, and detailed knowledge of procurement practices remains limited. Methods The use of the PT/LT Programme results as well as procurement and lot verification practices were assessed through a large-scale survey, gathering product-specific RDT sales and procurement data (2011–14 period) from a total of 32 manufacturers, 12 procurers and 68 National Malaria Control Programmes (NMCPs). Results Manufacturers’ reports showed that RDT sales had more than doubled over the four years, and confirmed a trend towards increased compliance with the WHO procurement criteria (from 83% in 2011 to 93% in 2014). Country-level reports indicated that 74% of NMCPs procured only ‘WHO-compliant’ RDT products, although procurers’ transactions datasets revealed a surprisingly frequent overlap of different products and even product types (e.g., Plasmodium falciparum-only and Plasmodium-pan) in the same year and country (60 and 46% of countries, respectively). Importantly, the proportion of ‘non-complying’ (i.e., PT low scored or not evaluated) products was found to be higher in the private health care sector than in the public sector (32% vs 5%), and increasing over time (from 22% of private sector sales in 2011 to 39% in 2014). An estimated 70% of the RDT market was covered by the LT programme. The opinion about the PT/LT Programmes was ...