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    Jan 17, 2021
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    A review of the WHO malaria rapid diagnostic test product testing programme (2008–2018): performance, procurement and policy

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    Cunningham et al 2019 A review ...
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    Authors
    Cunningham, J
    Jones, S
    Gatton, M
    Barnwell, J
    Cheng, Q
    Chiodini, P
    Glenn, J
    Gonzalez, I
    Kosack, C
    Nhem, S
    Gonzalez, I
    Rees-Channer, R
    Bell, D
    Menard, D
    Oyibo, W
    Luchavez, J
    Incardona, S
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    Issue Date
    2019-12-02
    Submitted date
    2019-12
    
    Metadata
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    Journal
    BMC Malaria Journal
    Abstract
    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.
    Publisher
    Springer Science and Business Media LLC
    URI
    http://hdl.handle.net/10144/619538
    DOI
    10.1186/s12936-019-3028-z
    Type
    journal-article
    Language
    en
    ISSN
    1475-2875
    ae974a485f413a2113503eed53cd6c53
    10.1186/s12936-019-3028-z
    Scopus Count
    Collections
    Malaria

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