Provided are methods for determining the amount of thyroglobulin in a sample using various purification steps followed by mass spectrometry. The methods generally involve purifying thyroglobulin in a test sample, digesting thyroglobulin to form peptide T129, purifying peptide T129, ionizing peptide T129, detecting the amount of peptide T129 ion generated, and relating the amount of peptide T129 ion to the amount of thyroglobulin originally present in the sample.

The present invention provides a method of diagnosing the existence or risk of hyperthyroidism in a feline comprising measuring the level of expression of one or more biomarkers selected from the group consisting of e.g., IYD, TG, SLC5A5, NIS, TPO, TSHR, DUOX1, DUOX2 (ThOX), TGFB1, CSTD, DCN and SEPP1 and the expression products thereof, in a biological sample from the feline, wherein elevated expression of the one or more biomarkers in the sample relative to a control value for expression in a sample from a normal feline or feline population, or a baseline value from the feline, indicates the existence or risk of hyperthyroidism; a method of treating a feline so diagnosed; and compositions, reagents and kits for carrying out the specified methods.

A method for the in vitro differential diagnosis of thyroid diseases is described comprising the step of determining by means of mass spectrometry in a biological sample the variation in intensity of at least one of the peaks (m/z) 0.3% selected from the group consisting of 10129 Th, 9749 Th, 10092 Th, 7935 Th, 4620 Th, 4748 Th, 8565 Th, 7565 Th, 4518 Th, 7936 Th, 5044 Th, 6699 Th, 11310 Th, 12277 Th, 6805 Th, 6880 Th, 8566 Th, 8309 Th, 5564 Th, 9711 Th, 7263 Th, 10296 Th and 4353 Th and/or of at least one of the peaks (m/z) 0.3% selected from the group consisting of 4987 Th, 7110 Th, 4804 Th, 9957 Th, 6719 Th, 4372 Th, 4196 Th, 4111 Th, 4282 Th, 5935 Th and 5519 Th.

The present invention provides a method and a kit for assaying a TSH receptor antibody, which are easy to manipulate and are safe. Specifically, the present invention provides a composition comprising a genetically modified cell forced to co-express a TSH receptor, a cyclic nucleotide responsive calcium channel, and a luminescent protein aequorin. Use of the composition enables the assay of a TSH receptor antibody contained in a sample.

Provided are methods for determining the amount of thyroglobulin in a sample using various purification steps followed by mass spectrometry. The methods generally involve purifying thyroglobulin in a test sample, digesting thyroglobulin to form peptide T129, purifying peptide T129, ionizing peptide T129, detecting the amount of peptide T129 ion generated, and relating the amount of peptide T129 ion to the amount of thyroglobulin originally present in the sample.

Provided are methods for determining the amount of thyroglobulin in a sample using various purification steps followed by mass spectrometry. The methods generally involve purifying thyroglobulin in a test sample, digesting thyroglobulin to form peptide T129, purifying peptide T129, ionizing peptide T129, detecting the amount of peptide T129 ion generated, and relating the amount of peptide T129 ion to the amount of thyroglobulin originally present in the sample.

The present invention includes a pharmaceutical composition and method of making and using comprising one or more thyroid hormones or analogs thereof, wherein a first portion of thyroid hormone is formulated for modified release and a second portion of the one or more thyroid hormones is formulated for modified release, wherein the combination of the first and second portion are provided in an amount effective to treat hypothyroidism.

The invention provides compositions and methods for detecting thyroid hormone blocking immunoglobulin (TBI). The invention's methods are sensitive and specific for TBI, and may be used for the dual detection of both TBI and TSI. The invention's compositions and methods are useful for the diagnosis of diseases that are associated with the presence of TBI and/or TSI, for monitoring the progress of disease and/or treatment regimens, therapeutics, vaccines, etc., and for assisting clinicians in making treatment decisions.

This application provides an antibody or antigen-binding fragment thereof that binds to thyroglobulin, including: a heavy chain variable region having: CDR-H1 having an amino acid sequence selected from SEQ ID NOs: 1, 7, 13, 19, 25, 31, and variants thereof, CDR-1-12 having an amino acid sequence selected from SEQ ID NOs: 2, 8, 14, 20, 26, 32, and variants thereof, and CDR-H3 having an amino acid sequence selected from SEQ ID NOs: 3, 9, 15, 21, 27, 33, and variants thereof; and a light chain variable region having: CDR-L1 having an amino acid sequence selected from SEQ ID NOs: 4, 10, 16, 22, 28, 34, and variants thereof, CDR-L2 having an amino acid sequence selected from SEQ ID NOs: 5, 11, 17, 23, 29, 35, and variants thereof, and CDR-L3 having an amino acid sequence selected from SEQ ID NOs: 6, 12, 18, 24, 30, 36, and variants thereof.

A method for identifying a patient that is at risk for developing a thyroid disorder that occurs subsequent to treatment with a regimen that depletes lymphocytes, comprising determining whether antibodies directed against thyroid peroxidase or thyroid microsomes are present in the patient, wherein if the antibodies are present in the patient then the patient is at increased risk for developing a thyroid disorder. A particular embodiment is a method for identifying a patient with multiple sclerosis that is at risk for developing a thyroid disorder that occurs subsequent to treatment with a regimen that depletes CD52-positive cells, comprising determining whether antibodies directed against thyroid peroxidase or thyroid microsomes are present in the patient, wherein if the antibodies are present in the patient then the patient is at risk for developing the thyroid disorder.