# US 8,771,967 B2 · Immunomodulation of functional T cell assays for diagnosis of infectious or autoimmune disorders

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- Number: US 8,771,967 B2
- Document ID: US8771967B2
- Status: Granted
- Kind: B2
- Application number: 13/297,818
- Filed: 2011-11-16
- Published: 2012-05-24
- Granted: 2014-07-08
- Earliest claimed: 2010-11-16
- Assignees: The Board of Trustees of the Leland Stanford Junior University
- Applicants: Niaz Banaei
- Inventors: Niaz Banaei
- Web page: https://patentgrep.com/patent/US8771967B2

## CPC

- G01N 33/6863: {Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors}
- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Improved assays for detecting the presence of a specific cell-mediated immune response in an individual are provided, where a sample comprising T cells and other cells of the immune system, usually a blood sample or derivative thereof, is contacted with test antigen(s) of interest in the presence of a pattern recognition receptor (PRR) agonist. The sample is incubated for a period of time sufficient to activate effector T cells; and release of immune effector molecule(s) is then detected. In some embodiments, the PRR is an agonist of a toll-like receptor (TLR) expressed by mature antigen presenting cells, including without limitation agonists TLR3 and TLR7, such as LPS, poly I:C, imiquimod, etc.

## Claims

### Claim 1

A method for measuring a cell mediated immune (CMI) response to a tuberculosis antigen in a subject, said method comprising:
collecting a cellular sample, comprising cells of the immune system that are capable of producing gamma interferon (IFNγ) following stimulation by antigen, from said subject;
incubating said cellular sample in vitro with a combination of tuberculosis antigen and LPS at a concentration of from 0.1 ng/ml to 100 ng/ml; and
measuring the level of IFNγ produced by the cellular sample in response to the tuberculosis antigen, wherein the level of IFNγ is indicative of the capacity of said subject to mount a cell-mediated immune response against the tuberculosis antigen.

### Claim 2 (depends on 1)

The method of claim 1 wherein the cellular sample is incubated with the antigen for from about 5 to about 50 hours.

### Claim 3 (depends on 1)

The method of claim 1 wherein the tuberculosis antigen is ESAT-6.

### Claim 4 (depends on 1)

The method of claim 1 wherein the tuberculosis antigen is CFP-10.

### Claim 5 (depends on 1)

The method of claim 1 wherein the tuberculosis antigen is PPD from Mycobacterium tuberculosis.

### Claim 6 (depends on 1)

The method of claim 1 wherein the immune effectors are detected using ELISA.

### Claim 7 (depends on 1)

The method of claim 1 wherein the immune effectors are detected using ELISpot.

### Claim 8 (depends on 1)

The method of claim 1, wherein said subject is immunocompromised.