Malaria Diagnostics in Clinical Trials

Sean C. Murphy Department of Laboratory Medicine, University of Washington Medical Center, Seattle, Washington; Division of Intramural Research, National Institute of Allergy and Infectious Diseases,National Institutes of Health, Bethesda, Maryland; Yale University School of Public Health, New Haven, Connecticut; Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, Washington; Hydas World Health, Hershey, Pennsylvania; Uniformed Services University of the Health Sciences, Bethesda, Maryland

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Joseph P. Shott Department of Laboratory Medicine, University of Washington Medical Center, Seattle, Washington; Division of Intramural Research, National Institute of Allergy and Infectious Diseases,National Institutes of Health, Bethesda, Maryland; Yale University School of Public Health, New Haven, Connecticut; Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, Washington; Hydas World Health, Hershey, Pennsylvania; Uniformed Services University of the Health Sciences, Bethesda, Maryland

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Sunil Parikh Department of Laboratory Medicine, University of Washington Medical Center, Seattle, Washington; Division of Intramural Research, National Institute of Allergy and Infectious Diseases,National Institutes of Health, Bethesda, Maryland; Yale University School of Public Health, New Haven, Connecticut; Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, Washington; Hydas World Health, Hershey, Pennsylvania; Uniformed Services University of the Health Sciences, Bethesda, Maryland

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Paige Etter Department of Laboratory Medicine, University of Washington Medical Center, Seattle, Washington; Division of Intramural Research, National Institute of Allergy and Infectious Diseases,National Institutes of Health, Bethesda, Maryland; Yale University School of Public Health, New Haven, Connecticut; Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, Washington; Hydas World Health, Hershey, Pennsylvania; Uniformed Services University of the Health Sciences, Bethesda, Maryland

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William R. Prescott Department of Laboratory Medicine, University of Washington Medical Center, Seattle, Washington; Division of Intramural Research, National Institute of Allergy and Infectious Diseases,National Institutes of Health, Bethesda, Maryland; Yale University School of Public Health, New Haven, Connecticut; Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, Washington; Hydas World Health, Hershey, Pennsylvania; Uniformed Services University of the Health Sciences, Bethesda, Maryland

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V. Ann Stewart Department of Laboratory Medicine, University of Washington Medical Center, Seattle, Washington; Division of Intramural Research, National Institute of Allergy and Infectious Diseases,National Institutes of Health, Bethesda, Maryland; Yale University School of Public Health, New Haven, Connecticut; Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, Washington; Hydas World Health, Hershey, Pennsylvania; Uniformed Services University of the Health Sciences, Bethesda, Maryland

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Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wide array of available malaria diagnostic tests for their suitability for screening trial participants and/or obtaining study endpoints for malaria clinical trials, including studies of HIV/malaria co-infection and other malaria natural history studies. The MLN provides recommendations on microscopy, rapid diagnostic tests, serologic tests, and molecular assays to guide selection of the most appropriate test(s) for specific research objectives. In addition, this report provides recommendations regarding quality management to ensure reproducibility across sites in clinical trials. Performance evaluation, quality control, and external quality assessment are critical processes that must be implemented in all clinical trials using malaria tests.

Author Notes

* Address correspondence to Sean C. Murphy, Department of Laboratory Medicine, University of Washington Medical Center, Seattle, WA 98195. E-mail: murphysc@uw.edu

Financial support: The Office of HIV/AIDS Network Coordination Malaria Laboratory Network is supported by grant U01A1068614. The authors are also supported by grants 1K08AI097238 (Sean C. Murphy), R01HD068174 (Sunil Parikh), and NO1-AI-85355 (William R. Prescott). Joseph P. Shott is supported by the Division of Intramural Research, NIAID, NIH.

Authors' addresses: Sean C. Murphy, Department of Laboratory Medicine, University of Washington Medical Center, Seattle, WA, E-mail: murphysc@uw.edu. Joseph P. Shott, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, E-mail: shottj@mail.nih.gov. Sunil Parikh, Yale University School of Public Health and Medicine, New Haven, CT, E-mail: sunil.parikh@yale.edu. Paige Etter, Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, WA, E-mail: petter@fhcrc.org. William R. Prescott, Hydas World Health, Hershey, PA, E-mail: william.prescott@hydasworldhealth.org. V. Ann Stewart, Uniformed Services University of the Health Sciences, Bethesda, MD, E-mail: astewart@usuhs.edu.

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