The Institute of Medicine report, 'Ending Neglect: The Elimination of Tuberculosis in the UnitedStates,' calls for the development of better tools for accurately identifying latently infectedindividuals. In countries such as the United States, where the incidence of latent tuberculosis isrelatively low, the specificity of the current tuberculin skin test is too low to yield a high positivepower of prediction.The goal of the proposed research is proof of concept for a diagnostic test of very highspecificity, based upon the ultra sensitive detection of a Mycobacterium tuberculosis (Mtb)protein in peripheral blood.
The specific aims are: to develop a bead capture ELISA sensitiveenough to detect the Mtb homolog of alpha-crystallin at a low picomolar concentration, and todemonstrate that this protein can be detected in sera from Mtb - infected subjects.If this very specific and sensitive diagnostic test can be developed and commercialized, it couldbe used to guide prophylactic treatment recommendations for individuals latently infected withMtb. Such a test has been identified as a high priority goal to facilitate a National plan toeliminate tuberculosis in the United States.
Research Narrative The goal of the proposed research is proof of concept for a previously developed diagnostic test for latent TB of high sensitivity and specificity, based upon the ultra sensitive detection of a Mycobacterium tuberculosis (Mtb) protein in peripheral blood. If this test can be developed and commercialized, it could be used to guide prophylactic treatment recommendations for individuals latently infected with Mtb.
