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.
PurposeThe purpose is to understand the role of public leadership during the COVID-19 pandemic and advocate for a more active role of public health professionals in helping manage the crisis.Design/methodology/approachThe authors use the framework developed by Boin et al. (2005) on crisis leadership. The authors focus on three of the core tasks – sense-making, decision-making and meaning-making – that are relevant to explain the role of public leaders during the ongoing crisis. The authors draw from the experience of three countries – Chile, France and the United States – to illustrate how these tasks were exercised with concrete examples.FindingsSeveral examples of the way in which public leaders reacted to the crisis are found in the selected countries. Countries show different responses to the way they assessed and reacted to the COVID-19 as a crisis, the decisions taken to prevent infections and mitigate consequences, and the way they communicate information to the population.Practical implicationsA better understanding public leadership as a key for better crisis management, particularly for designing policy responses to public health crises. Public health leaders need to assume a more active role in the crisis management process, which also implies the emergence of a new class of public health leaders and a more prominent role for public health in the public eye.Originality/valueThe use of examples from three different countries, as well as the focus on the core leadership tasks during an ongoing crisis help not only assessing the crisis management but also extracting lessons for the coming months, as well as future public health emergencies. The three authors have a first-hand experience on the evolution of the crisis in their countries and the environment, since they are currently living and working in public health in Chile, France and the United States.
BackgroundMalaria rapid diagnostic tests (RDTs) are appropriate for case management, but persistent antigenaemia is a concern for HRP2-detecting RDTs in endemic areas. It has been suggested that pan-pLDH test bands on combination RDTs could be used to distinguish persistent antigenaemia from active Plasmodium falciparum infection, however this assumes all active infections produce positive results on both bands of RDTs, an assertion that has not been demonstrated.MethodsIn this study, data generated during the WHO-FIND product testing programme for malaria RDTs was reviewed to investigate the reactivity of individual test bands against P. falciparum in 18 combination RDTs. Each product was tested against multiple wild-type P. falciparum only samples. Antigen levels were measured by quantitative ELISA for HRP2, pLDH and aldolase.ResultsWhen tested against P. falciparum samples at 200 parasites/μL, 92% of RDTs were positive; 57% of these on both the P. falciparum and pan bands, while 43% were positive on the P. falciparum band only. There was a relationship between antigen concentration and band positivity; ≥4 ng/mL of HRP2 produced positive results in more than 95% of P. falciparum bands, while ≥45 ng/mL of pLDH was required for at least 90% of pan bands to be positive.ConclusionsIn active P. falciparum infections it is common for combination RDTs to return a positive HRP2 band combined with a negative pan-pLDH band, and when both bands are positive, often the pan band is faint. Thus active infections could be missed if the presence of a HRP2 band in the absence of a pan band is interpreted as being caused solely by persistent antigenaemia.
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