Malaria diagnostics in clinical trials.
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.
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.
Sean C
SC
Murphy
Joseph P
JP
Shott
Sunil
S
Parikh
Paige
P
Etter
William R
WR
Prescott
V Ann
VA
Stewart
D002986:Clinical Trials as Topic; D060085:Coinfection; D003299:Cooperative Behavior; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D007118:Immunoassay / Q000592:standards; D008288:Malaria / Q000175:diagnosis* / Q000469:parasitology; D008853:Microscopy / Q000592:standards; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards* / Q000706:statistics & numerical data; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000592:standards
D011933:Reagent Kits, Diagnostic