title: Prototype Positive Control Wells for Malaria Rapid Diagnostic Tests: Prospective Evaluation of Implementation Among Health Workers in Lao People's Democratic Republic and Uganda.
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.
authors.affiliation: The Global Good Fund/Intellectual Ventures Lab, Bellevue, Washington.
authors.forename: David
authors.initials: D
authors.lastname: Bell
authors.affiliation: Malaria Consortium, Kampala, Uganda.
authors.forename: John Baptist
authors.initials: JB
authors.lastname: Bwanika
authors.affiliation: World Health Organization Global Malaria Programme, Geneva, Switzerland.
authors.forename: Jane
authors.initials: J
authors.lastname: Cunningham
authors.affiliation: Queensland University of Technology (QUT), Brisbane, Australia.
authors.forename: Michelle
authors.initials: M
authors.lastname: Gatton
authors.affiliation: Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
authors.forename: Iveth J
authors.initials: IJ
authors.lastname: González
authors.affiliation: Foundation for Innovative New Diagnostics (FIND), Kampala, Uganda.|Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
authors.forename: Heidi
authors.initials: H
authors.lastname: Hopkins
authors.affiliation: Makerere University School of Public Health, Kampala, Uganda.
authors.forename: Simon Peter S
authors.initials: SPS
authors.lastname: Kibira
authors.affiliation: Foundation for Innovative New Diagnostics (FIND), Kampala, Uganda.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Kyabayinze
authors.affiliation: Centre for Tropical Medicine and Global Health, Churchill Hospital, University of Oxford, Oxford, United Kingdom.|Faculty of Postgraduate Studies, University of Health Sciences, Vientiane, Lao People's Democratic Republic.|Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People's Democratic Republic.
authors.forename: Mayfong
authors.initials: M
authors.lastname: Mayxay
authors.affiliation: Foundation for Innovative New Diagnostics (FIND), Kampala, Uganda.
authors.forename: Bbaale
authors.initials: B
authors.lastname: Ndawula
authors.affiliation: Centre for Tropical Medicine and Global Health, Churchill Hospital, University of Oxford, Oxford, United Kingdom.|Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People's Democratic Republic.
authors.forename: Paul N
authors.initials: PN
authors.lastname: Newton
authors.affiliation: Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People's Democratic Republic.
authors.forename: Koukeo
authors.initials: K
authors.lastname: Phommasone
authors.affiliation: Malaria Consortium, Kampala, Uganda.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Streat
authors.affiliation: University of Bayreuth, Bayreuth, Germany.
authors.forename: René
authors.initials: R
authors.lastname: Umlauf
authors.lastname: Malaria Rdt Positive Control Well Field Study Group
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006282:Health Personnel; D006801:Humans; D007812:Laos / Q000453:epidemiology; D008288:Malaria / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D011446:Prospective Studies; D011785:Quality Assurance, Health Care; D015203:Reproducibility of Results; D014454:Uganda / Q000453:epidemiology; D055815:Young Adult