Prototype Positive Control Wells for Malaria Rapid Diagnostic Tests: Prospective Evaluation of Implementation Among Health Workers in Lao People's Democratic Republic and Uganda

Prototype Positive Control Wells for Malaria Rapid Diagnostic Tests: Prospective Evaluation of Implementation Among Health Workers in Lao People's Democratic Republic and Uganda

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...

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Bibliographic Details
Published in:The American journal of tropical medicine and hygiene Vol. 96; no. 2; pp. 319 - 329
Main Authors: Bell, David, Bwanika, John Baptist, Cunningham, Jane, Gatton, Michelle, González, Iveth J, Hopkins, Heidi, Kibira, Simon Peter S, Kyabayinze, Daniel J, Mayxay, Mayfong, Ndawula, Bbaale, Newton, Paul N, Phommasone, Koukeo, Streat, Elizabeth, Umlauf, René, Malaria Rdt Positive Control Well Field Study Group
Format: Journal Article
Language:English
Published: United States The American Society of Tropical Medicine and Hygiene 08-02-2017
Subjects:
Adolescent
Adult
Aged
Female
Health Personnel
Humans
Laos - epidemiology
Malaria - diagnosis
Male
Middle Aged
Point-of-Care Systems
Prospective Studies
Quality Assurance, Health Care
Reproducibility of Results
Uganda - epidemiology
Young Adult
Uganda
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Summary: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% ( < 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.
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ISSN:0002-9637
1476-1645
DOI:10.4269/ajtmh.16-0498