Patent ID: 8765366
Filing Date: 2014-07-01
Classification: G01N

Abstract:
1. A method for assessing and/or monitoring a Mycobacterium tuberculosis infection in an individual, said method comprising: (i) contacting a T-cell containing sample from said individual with a mycobacterial antigen, wherein the mycobacterial antigen is a peptide which is recognized by a T-cell and wherein the T-cell recognizes a natural T-cell epitope sequence in a naturally occurring (ii) detecting any cells that secrete IFN-γ and/or IL-2′ (iii) determining: (iv) inferring the mycobacterial load in the individual, wherein the proportion of (a) is positively correlated with mycobacterial load, the proportion of (b) is negatively correlated with mycobacterial load, and the proportion of (c) is negatively correlated with mycobacterial load; wherein the profile of cells that secrete IFN-γ only, ells that secrete IL-2 only, and cells that secrete both IFN-γ and IL-2 indicates the status of the infection as follows: (A) where an individual has recovered from tuberculosis, the likelihood of reactivation of the disease is positively correlated with (a) and negatively correlated with (b) and (c); (B) where an individual has tuberculosis, untreated disease is positively correlated with (a) and negatively correlated with (b) and (c), whereas treated disease is positively correlated with (b) and (c) and negatively correlated with (a); (C) where an individual has tuberculosis infection, active disease is positively correlated with (a) and negatively correlated with (b) and (c), whereas latent infection is positively correlated with (b) and (c) and negatively correlated with (a); (D) where an individual has a latent tuberculosis infection but no disease symptoms, the risk of progression or reactivation of the infection is positively correlated with (a) and negatively correlated with (b) and (c), such as in recently exposed individuals; (E) where an individual is being treated for tuberculosis infection, the success of the treatment correlates positively with (b) and (c) and negatively with (a).