Patent ID: 9244061
Filing Date: 2016-01-26
CPC Classification: C40B,G01N

Claim Text:
1. A kit for measuring a cell mediated immune (CMI) response to a TB antigen polypeptide of a biological sample from a subject, the kit comprising: a. a panel of at least two fusion polypeptides wherein each fusion polypeptide comprises a portion of a LF polypeptide lacking LF enzymatic activity but sufficient to promote transmembrane delivery of said fusion polypeptide to a cell, fused to a TB-specific antigen polypeptide, wherein said portion of a LF polypeptide comprises at least the 60 carboxy-terminal amino acids of SEQ ID NO: 3, or a conservative substitution variant thereof that promotes transmembrane delivery, wherein the panel of at least two fusion polypeptides comprises at least two different TB-specific antigen polypeptides, wherein one of the TB-specific antigen polypeptide is TB1 (CFP) polypeptide of SEQ ID NO: 7and wherein one of the TB-specific antigen polypeptide is TB2 (ESAT) polypeptide of SEQ ID NO: 6; and b. antibody-based detection means to detect INF-γreleased from the biological sample.