Method and device for identifying a mycobacterium species responsible for a mycobacterial infection

A method for detecting or identifying a Mycobacterium species in a biological sample, comprising:

• (a) providing a test substrate having bound thereto an antigen preparation from a culture of the standard Mycobacterium, wherein the antigen preparation comprises at least two immuno-cross-reactive antigen components (ImCRACs) such that the ImCRACs of the antigen preparation separate according to molecular weight;
• (b) contacting the bound ImCRACs of the test substrate with the biological sample under conditions that permit antibodies in the biological sample to bind with the substrate-bound ImCRACs to provide a pattern of substrate-bound antibody-ImCRAC complexes;
• (c) detecting the pattern of substrate-bound antibody-ImCRAC complexes;
• and
• (d) comparing the pattern of substrate-bound antibody-ImCRAC complexes from the sample to a library of standard patterns of substrate-bound antibody-ImCRAC complexes characteristic of particular Mycobacterium species,
• wherein matching of the pattern of substrate-bound antibody-ImCRAC-complexes from the sample to one of the standard patterns of substrate-bound antibody-ImCRAC complexes from the library permits detection or identification of the Mycobacterium species in the sample.

Diagnostic kit comprising:

• (1) a test substrate having bound thereto an antigen preparation from a culture of standard Mycobacterium,
• wherein the antigen preparation comprises at least two immuno-cross-reactive antigen components (ImCRACs) that are separable according to molecular weight, and
• wherein when the ImCRACs of the test substrate are contacted with a biological sample under conditions that permit antibodies in the biological sample to bind with the substrate-bound ImCRACs, a pattern of substrate-bound antibody-ImCRAC complexes is provided;
• and
• (2) a means for visualizing the pattern substrate-bound antibody-ImCRAC complexes.