Abstract
Rapid diagnostic tests (RDTs) are widely used for malaria diagnosis, but lack of quality control at point of care restricts trust in test results. Prototype positive control wells (PCW) containing recombinant malaria antigens have been developed to identify poor-quality RDT lots. This study assessed community and facility health workers' (HW) ability to use PCWs to detect degraded RDTs, the impact of PCW availability on RDT use and prescribing, and preferred strategies for implementation in Lao People's Democratic Republic (Laos) and Uganda. A total of 557 HWs participated in Laos (267) and Uganda (290). After training, most (88% to ≥ 99%) participants correctly performed the six key individual PCW steps; performance was generally maintained during the 6-month study period. Nearly all (97%) reported a correct action based on PCW use at routine work sites. In Uganda, where data for 127,775 individual patients were available, PCW introduction in health facilities was followed by a decrease in antimalarial prescribing for RDT-negative patients ≥ 5 years of age (4.7–1.9%); among community-based HWs, the decrease was 12.2% (P < 0.05) for all patients. Qualitative data revealed PCWs as a way to confirm RDT quality and restore confidence in RDT results. HWs in malaria-endemic areas are able to use prototype PCWs for quality control of malaria RDTs. PCW availability can improve HWs' confidence in RDT results, and benefit malaria diagnostic programs. Lessons learned from this study may be valuable for introduction of other point-of-care diagnostic and quality-control tools. Future work should evaluate longer term impacts of PCWs on patient management.
Highlights
Study area selection criteria were malaria Rapid diagnostic tests (RDTs) meeting World Health Organization (WHO) procurement criteria[18] already in routine use in clinical care according to plans/programs approved by the national malaria control authorities, representative sites in Africa and Asia, and local collaborators experienced in the conduct of operational research on malaria diagnosis
Steps that appeared challenging for some participants included filling the positive control wells (PCW) dropper with the correct amount of water, mixing the PCW solution for 120 seconds by counting or using a timer, and transferring a single drop of PCW solution to the correct RDT well
Results suggest that PCWs may improve health workers’ confidence in RDT results, and reduce antimalarial overtreatment of RDT-negative patients
Summary
Rapid diagnostic tests (RDTs) are widely used for malaria diagnosis, consistent with World Health Organization (WHO) recommendations for areas where good-quality malaria microscopy is not available, including peripheral health facilities and community-based fever management programs.[1,2] The need for stable, high-performing RDTs, especially under transport and storage conditions typical in malaria-endemic regions, has received considerable attention.[3,4,5] RDT lot-to-lot variation and susceptibility to deterioration upon exposure to high temperatures and humidity in supply chains have been documented.[6,7] In addition, some reports attribute health workers’ poor adherence to RDT results at least in part to lack of confidence in test results.[8,9] To maintain confidence in RDTs and optimize their utility, the tests must demonstrate consistently reliable results. RDT quality control, after field deployment, is currently difficult to implement in routine health-care contexts.[10,11,12]
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