Rapid Diagnostic Tests (RDTs) for Malaria in Kampala, Uganda
Condition: Febrile Illness; Malaria
MeSH terms: Malaria
Study type: Observational

Summary: 
      Malaria remains a disease that causes much death and sickness, especially in sub-Saharan
      Africa. An accurate, simple, and inexpensive method of diagnosing malaria is urgently needed.
      The purpose of this study is to evaluate a different diagnostic method compared to those most
      frequently used. The study may also identify the factors causing false positive and false
      negative results using the alternative method. Participants will be 600 Ugandan children aged
      1-10 years who are enrolled in protocol 04-068. Those who develop a fever over the 12 month
      duration of the study will be tested for malaria by both the standard and the new methods.
      These tests will require a few drops of blood to be collected by finger prick. Subjects will
      be treated on the basis of standard diagnostic testing (i.e. expert microscopy).
    

Detailed description: 
      Malaria remains one of the most devastating infectious diseases, causing high morbidity and
      mortality especially in sub-Saharan Africa. The need for an accurate, simple, and inexpensive
      method to diagnose malaria has become increasingly urgent. Rapid diagnostic tests (RDTs),
      based on detection of Plasmodium antigens, may represent a more practical diagnostic tool
      than traditional light microscopy. This longitudinal study's objectives are (1) to evaluate
      the clinical performance (sensitivity, specificity, positive and negative predictive values)
      of RDTs, as compared with presumptive diagnosis and microscopy, for the diagnosis of malaria
      in children in Kampala, Uganda, and (2) to identify host and test factors that lead to false
      positive and false negative RDT results by comparison with polymerase chain reaction (PCR)
      analysis. Study subjects in this RDT study will have already been enrolled in a larger
      on-going longitudinal study of antimalarial drug efficacy, tolerability, and safety that
      began at the Kampala study site in late 2004. In the RDT study, over a one-year period, study
      participants' blood samples will be evaluated with the current gold standard for malaria
      diagnosis (microscopy) as well as two types of RDT whenever they present with a new fever
      episode (the first fever after study enrollment, or a fever that occurs more than 14 days
      after the patient's most recently diagnosed episode of malaria). As part of the on-going
      longitudinal drug efficacy trial, probability sampling was used to select a random sample of
      600 children, who will be followed for three years for all their health-care needs. The RDT
      study will involve evaluation of the cohort over 12 months, beginning in approximately the
      third quarter of 2005. This protocol is a substudy of 04-068.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        601 children enrolled in a longitudinal antimalarial treatment efficacy trial in Kampala,
        Uganda.
      
Biospecimen description: 
      Dried blood spots on filter paper
    
Keywords: malaria; fever; Uganda; children; rapid diagnostic tests; RDTs; Africa