Patent ID: 7745141

Claim:
A method for the early detection of active Mycobacterium tuberculosis (Mtb) disease or infection in a subject, comprising assaying a biological fluid sample from an asymptomatic subject or a subject having constitutional symptoms of tuberculosis, but before the onset of specific symptoms identifiable as advanced tuberculosis, for the presence of early antibodies specific for one or more early Mtb antigens which antigens are characterized as being surface or secreted proteins that are (i) bound by antibodies found in tuberculosis patients who are in a stage of disease prior to the onset of (a) smear-positivity of sputum or other pulmonary associated fluid for acid-fast bacilli and (b) cavitary pulmonary lesions, and (ii) non-reactive with sera from healthy control subjects or healthy subjects with latent inactive tuberculosis and which antibodies are specific for an antigen selected from the group consisting of (a) PirG protein encoded by the Mtb gene Rv3810; (b) PE-PGRS protein encoded by the Mtb gene Rv3367; (c) PTRP protein encoded by the Mtb gene Rv0538; (d) MtrA protein encoded by the Mtb gene Rv3246c; and (e) an epitope of any one of (a)-(d), wherein the presence of said early antibodies specific for said early antigens is indicative of the presence of said disease or infection.