The invention relates to assay methods and kits for assessing autoimmune diseases in a human subject. In embodiments, the present disclosure provides assay methods and kits for diagnosing a subject with or predicting that a subject will develop Type 1 diabetes. In embodiments, the present disclosure provides assay methods and kits for assessing responsiveness of a subject having Type 1 diabetes to treatment with alefacept. In embodiments, the present disclosure provides assay methods and kits for diagnosing a subject with systemic lupus erythematosus. In embodiments, the present disclosure provides assay methods and kits for determining if a subject is at risk of a systemic lupus erythematosus flare. In embodiments, the present disclosure provides assay methods and kits for diagnosing a subject with celiac disease.

A method for determining the health status of an elderly individual by testing the sample extracted from the individual for the presence of biomarkers, the bio markers being autoantibodies to antigens comprising MAPK13, CD96, FKBP3, PPM1A, PHLDA1, GLRX3, FEN1 and AURKA, wherein the antigens may further comprise one or more of UBE2I, AAK1, YARS, ASPSCR1, CASP10, FHOD2, TCL1A and MAP4, wherein PHLDA1 and CD96 correspond to healthy, AURKA, FEN1, CASP10 and AAK1 correspond to intermediate health, and UBE2I, YARS, ASPSCR1, FHOD2, TCL1A, MAP4, MAPK13, FKBP3, PPM1A and GLRX3 correspond to unhealthy.

A method for determining the health status of an elderly individual by testing the sample extracted from the individual for the presence of biomarkers, the bio markers being autoantibodies to antigens comprising MAPK13, CD96, FKBP3, PPM1A, PHLDA1, GLRX3, FEN1 and AURKA, wherein the antigens may further comprise one or more of UBE2I, AAK1, YARS, ASPSCR1, CASP10, FHOD2, TCL1A and MAP4, wherein PHLDA1 and CD96 correspond to healthy, AURKA, FEN1, CASP10 and AAK1 correspond to intermediate health, and UBE2I, YARS, ASPSCR1, FHOD2, TCL1A, MAP4, MAPK13, FKBP3, PPM1A and GLRX3 correspond to unhealthy.

Methods and reagents for diagnosing, prognosing, and treating systemic lupus erythematosus (SLE) are disclosed, involving calculating an SLE risk score for a subject based on a level of each of an erythrocyte C4d (EC4d) marker, a B-cell C4d (BC4d) marker, anti-nuclear antibodies (ANA), and optional rule-out markers.

Methods and reagents for diagnosing, prognosing, and treating systemic lupus erythematosus (SLE) are disclosed, involving calculating an SLE risk score for a subject based on a level of each of an erythrocyte C4d (EC4d) marker, a B-cell C4d (BC4d) marker, anti-nuclear antibodies (ANA), and optional rule-out markers.

Embodiments are directed to methods of examining preimplantation factor (PIF) binding to a subject's circulating immune cells as a marker for immune dysregulation. Some embodiments are directed to methods of detecting a level of immune dysregulation sufficient to cause recurrent pregnancy loss (RPL), methods of detecting a level of immune dysfunction sufficient to cause endometriosis, and methods of detecting a level of immune dysfunction comprising administering an effective amount of PIF or an analog thereof, and examining its binding to circulating immune cells. Within those methods, an about twenty percent change in PIF binding to a subject's circulating immune cells indicates a level of immune dysfunction.

Embodiments are directed to methods of examining preimplantation factor (PIF) binding to a subject's circulating immune cells as a marker for immune dysregulation. Some embodiments are directed to methods of detecting a level of immune dysregulation sufficient to cause recurrent pregnancy loss (RPL), methods of detecting a level of immune dysfunction sufficient to cause endometriosis, and methods of detecting a level of immune dysfunction comprising administering an effective amount of PIF or an analog thereof, and examining its binding to circulating immune cells. Within those methods, an about twenty percent change in PIF binding to a subject's circulating immune cells indicates a level of immune dysfunction.

The invention relates to the use in vitro of a kit for diagnostics, more particularly therapy-accompanying diagnostics, relating to a transplant and/or for diagnostics, more particularly therapy-accompanying diagnostics, relating to an autoimmune disease and/or for diagnostics, more particularly therapy-accompanying diagnostics, relating to a tumor disease and/or for diagnostics, more particularly therapy-accompanying diagnostics, relating to a vaccination, wherein the kit has the following components: a blood collection container, a blood collection set or blood collection system including a blood collection container, a nutrient medium for blood, and at least one activator for activating blood cells, more particularly immune cells, and/or at least one inhibitor for inhibiting blood cells, more particularly immune cells, and/or at least one modulator for modulating blood cells, more particularly immune cells.

The invention further relates to the use in vitro of a method for diagnostics in transplants and/or autoimmune diseases and/or tumor diseases and/or vaccinations, to a messenger-substance-containing supernatant for use in vitro in diagnostics in transplants and/or autoimmune diseases and/or tumor diseases and/or vaccinations, and to a combination for use in diagnostics in transplants and/or autoimmune diseases and/or tumor diseases and/or vaccinations.

The invention relates to the use in vitro of a kit for diagnostics, more particularly therapy-accompanying diagnostics, relating to a transplant and/or for diagnostics, more particularly therapy-accompanying diagnostics, relating to an autoimmune disease and/or for diagnostics, more particularly therapy-accompanying diagnostics, relating to a tumor disease and/or for diagnostics, more particularly therapy-accompanying diagnostics, relating to a vaccination, wherein the kit has the following components: a blood collection container, a blood collection set or blood collection system including a blood collection container, a nutrient medium for blood, and at least one activator for activating blood cells, more particularly immune cells, and/or at least one inhibitor for inhibiting blood cells, more particularly immune cells, and/or at least one modulator for modulating blood cells, more particularly immune cells.

The invention further relates to the use in vitro of a method for diagnostics in transplants and/or autoimmune diseases and/or tumor diseases and/or vaccinations, to a messenger-substance-containing supernatant for use in vitro in diagnostics in transplants and/or autoimmune diseases and/or tumor diseases and/or vaccinations, and to a combination for use in diagnostics in transplants and/or autoimmune diseases and/or tumor diseases and/or vaccinations.

The present invention generally relates to kits for detecting Mycobacterium avium subspecies paratuberculosis (MAP) infection and biomarkers correlated with MAP-associated diseases or disorders. The present method also relates to methods of diagnosing a subject with a MAP-associated autoimmune disease or disorder and/or determining the treatment course of a subject diagnosed with a MAP-associated autoimmune disease or disorder.