The rapid advances that have been made in molecular biology and
molecular methods have led, and continue to lead, 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 booklet for designing
and conducting diagnostic evaluations provide an outline for ensuring
the proper evaluation of new diagnostics in laboratory and field trials.