1. A kit for measuring cell-mediated immune response activity in a subject, the kit comprising: a combination of two sets of peptides, a first set comprising peptides of from about 7 to 14 amino acid residues in length which are recognised by CD8+ lymphocytes and a second set comprising peptides of from 16 amino acid residues or greater which are recognised by CD4+ lymphocytes, which peptides encompass all or part of a protein antigen, wherein the combination of the two sets of peptides is for co-incubating with lymphocytes from the subject and measuring for the presence or elevation in the level of an immune effector molecule from immune cells wherein the presence or level of the immune effector molecule is indicative of the level of cell-mediated responsiveness of the subject.
2. The kit of Claim 1 further comprising an antibody specific for the immune effector molecule.
3. The kit of Claim 1 or Claim 2 wherein the immune effector molecule is a cytokine.
4. The kit of Claim 3 wherein the cytokine is IFN- .
5. The kit of any one of Claims 1 to 4 wherein the immune effector molecule is detected using ELISA.
6. The kit of any one of Claims 1 to 5 wherein the immune effector molecule is detected using ELISpot.
7. The kit of any one of Claims 1 to 6 wherein the subject has an infection by a pathogenic agent selected from Mycobacterium species, Staphylococcus species, Streptococcus species, Borrelia species, Escherichia coli, Salmonella species, Clostridium species, Shigella species, Proteus species, Bacillus species, Herpes virus, Hepatitis B or C virus and Human immune deficiency virus (HIV) or a disease resulting therefrom.
8. The kit of Claim 7 wherein the disease condition is an infection by Mycobacterium tuberculosis or tuberculosis (TB).

9. The kit of Claim 8 wherein the antigen is selected from CFP10, ESAT-6, TB7.7 and TB37.6.
10. The kit of any one of Claims 1 to 6 wherein the subject has a disease condition selected from alopecia areata, ankylosing spondylitis, antiphospholipid syndrome, autoimmune Addison's disease multiple sclerosis, autoimmune disease of the adrenal gland, autoimmune hemolytic anemia, autoimmune hepatitis, autoimmune oophoritis and orchitis, Behcet's disease, bullous pemphigoid, cardiomyopathy, celiac sprue-dermatitis, chronic fatigue syndrome (CFIDS), chronic inflammatory demyelinating, chronic inflammatory polyneuropathy, Churg-Strauss syndrome, cicatricial pemphigoid, crest syndrome, cold agglutinin disease, Crohn's disease, dermatitis herpetiformis, discoid lupus, essential mixed cryoglobulinemia, fibromyalgia, glomerulonephritis, Grave's disease, Guillain-Barre, Hashimoto's thyroiditis, idiopathic pulmonary fibrosis, idiopathic thrombocytopenia purpura (ITP), IgA nephropathy, insulin dependent diabetes (Type I), lichen planus, lupus, Meniere's disease, mixed connective tissue disease, multiple sclerosis, myasthenia gravis, myocarditis, pemphigus vulgaris, pernicious anemia, polyarteritis nodosa, polychondritis, polyglancular syndromes, polymyalgia rheumatica, polymyositis and dermatomyositis, primary agammaglobulinemia, primary biliary cirrhosis, psoriasis, Raynaud's phenomenon, Reiter's syndrome, rheumatic fever, rheumatoid arrthritis, sarcoidosis, scleroderma, Sjogren's syndrome, stiff-man syndrome, systemic lupus erythematosus, Takayasu arteritis, temporal arteritis/gianT-cell arteritis, ulcerative colitis, uveitis, vasculitis, vitiligo and inflammatory bowel disease.
11. The kit of any one of Claims 1 to 6 wherein the disease is Celiac's disease.
12. The kit of any one of Claims 1 to 6 wherein the disease is autoimmune diabetes.
13. The kit of any one of Claims 1 to 6 wherein the subject has a cancer selected from ABL1 protooncogene, AIDS related cancers, acoustic neuroma, acute lymphocytic leukaemia, acute myeloid leukaemia, adenocystic carcinoma, adrenocortical cancer, agnogenic myeloid metaplasia, alopecia, alveolar soft-part sarcoma, anal cancer, angiosarcoma, aplastic anaemia, astrocytoma, ataxia-telangiectasia, basal cell carcinoma

(skin), bladder cancer, bone cancers, bowel cancer, brain stem glioma, brain and CNS tumors, breast cancer, CNS tumors, carcinoid tumors, cervical cancer, childhood brain tumors, childhood cancer, childhood leukaemia, childhood soft tissue sarcoma, chondrosarcoma, choriocarcinoma, chronic lymphocytic leukaemia, chronic myeloid leukaemia, colorectal cancers, cutaneous T-Cell lymphoma, dermatofibrosarcoma-protuberans, desmoplastic-small-round-cell-tumor, ductal carcinoma, endocrine cancers, endometrial cancer, ependymoma, esophageal cancer, Ewing’s sarcoma, extra-hepatic bile duct cancer, eye cancer, eye: melanoma, retinoblastoma, fallopian tube cancer, fanconi anemia, fibrosarcoma, gall bladder cancer, gastric cancer, gastrointestinal cancers, gastrointestinal-carcinoid-tumor, genitourinary cancers, germ cell tumors, gestational-trophoblastic-disease, glioma, gynaecological cancers, hematological malignancies, hairy cell leukaemia, head and neck cancer, hepatocellular cancer, hereditary breast cancer, histiocytosis, Hodgkin’s disease, human papillomavirus, hydatidiform mole, hypercalcemia, hypopharynx cancer, intraocular melanoma, islet cell cancer, Kaposi’s sarcoma, kidney cancer, Langerhan’s-cell-histiocytosis, laryngeal cancer, leiomyosarcoma, leukemia, Li-Fraumeni syndrome, lip cancer, liposarcoma, liver cancer, lung cancer, lymphedema, lymphoma, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, male breast cancer, malignant-rhabdoid-tumor-of-kidney, medulloblastoma, melanoma, merkel cell cancer, mesothelioma, metastatic cancer, mouth cancer, multiple endocrine neoplasia, mycosis fungoides, myelodysplastic syndromes, myeloma, myeloproliferative disorders, nasal cancer, nasopharyngeal cancer, nephroblastoma, neuroblastoma, neurofibromatosis, nijmegen breakage syndrome, non-melanoma skin cancer, non-small-cell-lung-cancer-(NSCLC), ocular cancers, oesophageal cancer, oral cavity cancer, oropharynx cancer, osteosarcoma, ostomy ovarian cancer, pancreas cancer, paranasal cancer, parathyroid cancer, parotid gland cancer, penile cancer, peripheral-neuroectodermal-tumors, pituitary cancer, polycythemia vera, prostate cancer, rare-cancers-and-associated-disorders, renal cell carcinoma, retinoblastoma, rhabdomyosarcoma, Rothmund-Thomson syndrome, salivary gland cancer, sarcoma, schwannoma, Sezary syndrome, skin cancer, small cell lung cancer (SCLC), small intestine cancer, soft tissue sarcoma, spinal cord tumors, squamous-cell-carcinoma-(skin), stomach cancer, synovial sarcoma, testicular cancer, thymus cancer, thyroid cancer, transitional-cell-cancer-(bladder), transitional-cell-cancer-(renal-pelvis-/-ureter), trophoblastic cancer, urethral cancer, urinary system

cancer, uroplakins, uterine sarcoma, uterus cancer, vaginal cancer, vulva cancer, Waldenstrom’s-macroglobulinemia and Wilms’ tumor.
14. The kit of any one of Claims 1 to 6 wherein the subject was exposed to a proteinaceous toxicant.
15. The kit of any one of Claims 1 to 14 wherein the magnitude of the cell-mediated immune response correlates with the state, progression and/or severity of a disease condition.
16. The kit of any one of Claims 1 to 15 wherein the subject is a human.
17. The kit of any one of Claims 1 to 16 wherein the lymphocytes are comprised in a blood sample and the blood sample is undiluted whole blood.
18. The kit of any one of Claims 1 to 16 wherein the lymphocytes are comprised in a blood sample and the blood sample is whole blood which comprises from about 10% to 100% by volume of the sample to be assayed.
19. The kit of Claim 18 wherein the whole blood comprises from about 50% to 100% by volume of the sample to be assayed.
20. The kit of Claim 19 wherein the whole blood comprises from about 80% to 100% by volume of the sample to be assayed.
21. The kit of any one of Claims 17 to 20 wherein the whole blood is collected in a tube comprising heparin.
22. A composition for measuring cell-mediated immune response activity in a subject,
the composition comprising lymphocytes from the subject, which lymphocytes are co-
incubated with a combination of two sets of peptides, a first set comprising peptides of
from about 7 to 14 amino acid residues in length which are recognised by CD8+
lymphocytes and a second set comprising peptides of from 16 amino acid residues or
greater which are recognised by CD4+ lymphocytes, which peptides encompass all or

part of a protein antigen, wherein the composition optionally comprises an immune effector molecule from immune cells, wherein a presence or level of the immune effector molecule is indicative of the level of cell-mediated responsiveness of the subject.
23. The composition of Claim 22 wherein the subject is a human.
24. The composition of Claim 22 or 23 wherein the lymphocytes from the subject are comprised within a blood sample and the blood sample is undiluted whole blood.
25. The composition of Claim 22 or 23 wherein the lymphocytes from the subject are comprised within a blood sample and the blood sample is whole blood which comprises from about 10% to 100% by volume of the sample to be assayed.
26. The composition of Claim 25 wherein the whole blood comprises from about 50% to 100% by volume of the sample to be assayed.
27. The composition of Claim 26 wherein the whole blood comprises from about 80% to 100% by volume of the sample to be assayed.
28. The composition of any one of Claims 24 to 27 wherein the whole blood is collected in a tube comprising heparin.
29. The composition of any one of Claims 22 to 28 wherein the immune effector molecule is a cytokine.
30. The composition of Claim 29 wherein the cytokine is IFN- .
31. The composition of any one of Claims 22 to 30, further comprising an antibody specific for the immune effector molecule.
32. The composition of Claim 31 wherein the immune effector molecule is detectable using ELISA.

33. The composition of Claim 32 wherein the immune effector molecule is detectable using ELISpot.
34. The composition of any one of Claims 22 to 33 wherein the subject has an infection by a pathogenic agent selected from Mycobacterium species, Staphylococcus species, Streptococcus species, Borrelia species, Escherichia coli, Salmonella species, Clostridium species, Shigella species, Proteus species, Bacillus species, Herpes virus, Hepatitis B or C virus and Human immune deficiency virus (HIV) or a disease resulting therefrom.
35. The composition of Claim 34 wherein the disease condition is an infection by Mycobacterium tuberculosis or tuberculosis (TB).
36. The composition of Claim 35 wherein the antigen is selected from CFP10, ESAT-6, TB7.7 and TB37.6.
37. The composition of any one of Claims 22 to 33 wherein the subject has a disease condition selected from alopecia areata, ankylosing spondylitis, antiphospholipid syndrome, autoimmune Addison's disease multiple sclerosis, autoimmune disease of the adrenal gland, autoimmune hemolytic anemia, autoimmune hepatitis, autoimmune oophoritis and orchitis, Behcet's disease, bullous pemphigoid, cardiomyopathy, celiac sprue-dermatitis, chronic fatigue syndrome (CFIDS), chronic inflammatory demyelinating, chronic inflammatory polyneuropathy, Churg-Strauss syndrome, cicatricial pemphigoid, crest syndrome, cold agglutinin disease, Crohn's disease, dermatitis herpetiformis, discoid lupus, essential mixed cryoglobulinemia, fibromyalgia, glomerulonephritis, Grave's disease, Guillain-Barre, Hashimoto's thyroiditis, idiopathic pulmonary fibrosis, idiopathic thrombocytopenia purpura (ITP), IgA nephropathy, insulin dependent diabetes (Type I), lichen planus, lupus, Meniere's disease, mixed connective tissue disease, multiple sclerosis, myasthenia gravis, myocarditis, pemphigus vulgaris, pernicious anemia, polyarteritis nodosa, polychondritis, polyglancular syndromes, polymyalgia rheumatica, polymyositis and dermatomyositis, primary agammaglobulinemia, primary biliary cirrhosis, psoriasis, Raynaud's phenomenon, Reiter's syndrome, rheumatic fever, rheumatoid arrthritis, sarcoidosis, scleroderma, Sjogren's syndrome, stiff-man syndrome, systemic lupus erythematosus, Takayasu

arteritis, temporal arteritis/gianT-cell arteritis, ulcerative colitis, uveitis, vasculitis, vitiligo and inflammatory bowel disease.
38. The composition of any one of Claims 22 to 33 wherein the disease is Celiac's disease.
39. The composition of any one of Claims 22 to 33 wherein the disease is autoimmune diabetes.
40. The composition of any one of Claims 22 to 33 wherein the subject has a cancer selected from ABL1 protooncogene, AIDS related cancers, acoustic neuroma, acute lymphocytic leukaemia, acute myeloid leukaemia, adenocystic carcinoma, adrenocortical cancer, agnogenic myeloid metaplasia, alopecia, alveolar soft-part sarcoma, anal cancer, angiosarcoma, aplastic anaemia, astrocytoma, ataxia-telangiectasia, basal cell carcinoma (skin), bladder cancer, bone cancers, bowel cancer, brain stem glioma, brain and CNS tumors, breast cancer, CNS tumors, carcinoid tumors, cervical cancer, childhood brain tumors, childhood cancer, childhood leukaemia, childhood soft tissue sarcoma, chondrosarcoma, choriocarcinoma, chronic lymphocytic leukaemia, chronic myeloid leukaemia, colorectal cancers, cutaneous T-Cell lymphoma, dermatofibrosarcoma-protuberans, desmoplastic-small-round-cell-tumor, ductal carcinoma, endocrine cancers, endometrial cancer, ependymoma, esophageal cancer, Ewing’s sarcoma, extra-hepatic bile duct cancer, eye cancer, eye: melanoma, retinoblastoma, fallopian tube cancer, fanconi anemia, fibrosarcoma, gall bladder cancer, gastric cancer, gastrointestinal cancers, gastrointestinal-carcinoid-tumor, genitourinary cancers, germ cell tumors, gestational-trophoblastic-disease, glioma, gynaecological cancers, hematological malignancies, hairy cell leukaemia, head and neck cancer, hepatocellular cancer, hereditary breast cancer, histiocytosis, Hodgkin’s disease, human papillomavirus, hydatidiform mole, hypercalcemia, hypopharynx cancer, intraocular melanoma, islet cell cancer, Kaposi’s sarcoma, kidney cancer, Langerhan’s-cell-histiocytosis, laryngeal cancer, leiomyosarcoma, leukemia, Li-Fraumeni syndrome, lip cancer, liposarcoma, liver cancer, lung cancer, lymphedema, lymphoma, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, male breast cancer, malignant-rhabdoid-tumor-of-kidney, medulloblastoma, melanoma, merkel cell cancer, mesothelioma, metastatic cancer, mouth cancer, multiple endocrine neoplasia, mycosis fungoides, myelodysplastic

syndromes, myeloma, myeloproliferative disorders, nasal cancer, nasopharyngeal cancer, nephroblastoma, neuroblastoma, neurofibromatosis, nijmegen breakage syndrome, non-melanoma skin cancer, non-small-cell-lung-cancer-(NSCLC), ocular cancers, oesophageal cancer, oral cavity cancer, oropharynx cancer, osteosarcoma, ostomy ovarian cancer, pancreas cancer, paranasal cancer, parathyroid cancer, parotid gland cancer, penile cancer, peripheral-neuroectodermal-tumors, pituitary cancer, polycythemia vera, prostate cancer, rare-cancers-and-associated-disorders, renal cell carcinoma, retinoblastoma, rhabdomyosarcoma, Rothmund-Thomson syndrome, salivary gland cancer, sarcoma, schwannoma, Sezary syndrome, skin cancer, small cell lung cancer (SCLC), small intestine cancer, soft tissue sarcoma, spinal cord tumors, squamous-cell-carcinoma-(skin), stomach cancer, synovial sarcoma, testicular cancer, thymus cancer, thyroid cancer, transitional-cell-cancer-(bladder), transitional-cell-cancer-(renal-pelvis-/-ureter), trophoblastic cancer, urethral cancer, urinary system cancer, uroplakins, uterine sarcoma, uterus cancer, vaginal cancer, vulva cancer, Waldenstrom’s-macroglobulinemia and Wilms’ tumor.
41. The composition of any one of Claims 22 to 33 wherein the subject was exposed to a proteinaceous toxicant.
42. The composition of any one of Claims 22 to 41 wherein the magnitude of the cell-mediated immune response correlates with the state, progression and/or severity of a disease condition.