Malaria diagnostics in clinical trials

Am J Trop Med Hyg. 2013 Nov;89(5):824-39. doi: 10.4269/ajtmh.12-0675. Epub 2013 Sep 23.

Abstract

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, N.I.H., Intramural
  • Review

MeSH terms

  • Clinical Trials as Topic*
  • Coinfection
  • Cooperative Behavior
  • HIV Infections / diagnosis*
  • HIV Infections / virology
  • Humans
  • Immunoassay / standards
  • Malaria / diagnosis*
  • Malaria / parasitology
  • Microscopy / standards
  • Quality Control
  • Reagent Kits, Diagnostic / standards*
  • Reagent Kits, Diagnostic / statistics & numerical data
  • Reverse Transcriptase Polymerase Chain Reaction / standards

Substances

  • Reagent Kits, Diagnostic