Diagnostic test needs for evaluating antituberculosis vaccines

Abstract

To aid in the evaluation of preexposure and postinfection vaccines to prevent tuberculosis, diagnostic tests are needed that can clearly distinguish immunologic protection from vaccine failure in a timely manner. The currently available tests to detect infected persons (tuberculin skin-test) and confirm active disease (conventional culture methods) have limitations in specificity, sensitivity, or timeliness. Research to identify (1) surrogate markers of infection, disease, or protection and (2) stage-specific antigens or immune responses holds some promise for the development of new tests that can distinguish the various outcomes of an infection or a vaccination.