Methods for field trials of malaria rapid diagnostic tests
The rapid advances that have been made in molecular biology and molecular methods have led to the development of sensitive and specific diagnostic tests, which hold the promise of substantially strengthening our ability to diagnose, treat and control many of the major infectious diseases in developing countries. It is imperative that these new diagnostics are rigorously and properly evaluated in the situations in which they will be deployed in disease control before they are released for general use. A poorly performing diagnostic might not only waste resources but might also impede disease control.
The basic procedures described in this guide for designing and conducting diagnostic evaluations provide an outline for ensuring the proper evaluation of new diagnostics in laboratory and field trials.
This guide was developed by WHO/WPRO and WHO/TDR through an informal consultation on field trials and guidelines for malaria rapid diagnostic tests held in Manila, Philippines in 2003, and by the WHO/TDR Diagnostics Expert Evaluation Panel (DEEP). It was first published with Nature Reviews Microbiology as a supplement: ''Ensuring quality and access for malaria diagnosis: how can it be achieved? Nat Rev Microbiol. 2006 Sep;4(9 Suppl):S21-40''.