Compositions and methods for detecting autoantibodies
AssigneeOrtho-Clinical Diagnostics, Inc.
InventorsYunsheng Li, Paul D. Olivo, Hannah Jaekyung Kim
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Abstract
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.
Claims17
A method for detecting thyroid hormone blocking immunoglobulin (TBI) in a sample, comprising:
- a) combining each of a biological sample from a subject and a control sample with
- i) transgenic cells stably or transiently transfected with one or more expression vectors comprising
- 1) A first nucleic acid sequence that encodes a reporter, wherein said first nucleotide sequence is operably linked to a CAMP-inducible promoter, and
- 2) The nucleotide sequence of SEQ ID NO:
- 2 that encodes a chimeric TSH receptor (TSHR), wherein said SEQ ID NO:
- 2 is operably linked to a constitutive promoter,
- wherein said cells express said chimeric TSHR on the cell membrane, and
- ii) a thyroid stimulating polypeptide that stimulates said chimeric TSHR upon binding to said TSHR, wherein said thyroid stimulating polypeptide is selected from the group consisting of thyroid stimulating hormone (TSH), a thyroid stimulating monoclonal antibody, and thyroid stimulating polyclonal antibody,
- wherein said combining said transgenic cells and said thyroid stimulating polypeptide with
- A) said control sample produces a first sample, and
- B) said biological sample produces a second sample, and
- is under conditions for binding of said thyroid stimulating polypeptide to said chimeric TSHR, and
- b) measuring the level of expression of said reporter in said first sample and in said second sample, wherein a reduced level of expression of said reporter in said second sample compared to said first sample indicates the presence of TBI in said test sample.
A method for detecting thyroid hormone blocking immunoglobulin (TBI) and thyroid hormone stimulating immunoglobulin (TSI) in a biological sample, comprising:
- a) combining each of a biological sample and a control sample with
- i) transgenic cells stably or transiently transfected with one or more expression vectors comprising a
- 1) A first nucleic acid sequence that encodes a reporter, wherein said first nucleic acid sequence is operably linked to a cAMP-inducible promoter, and
- 2) The nucleotide sequence of SEQ ID NO:
- 2 that encodes a chimeric TSH receptor (TSHR), wherein said SEQ ID NO:
- 2 is operably linked to a constitutive promoter,
- wherein said cells express said chimeric TSHR on the cell membrane, and
- ii) a thyroid stimulating polypeptide,
- wherein said combining said transgenic cells and said thyroid stimulating polypeptide with
- A) said control sample produces a first sample, and
- B) said biological sample produces a second sample, and
- is under conditions for binding of said thyroid stimulating polypeptide to said chimeric TSHR, and
- b) measuring the level of expression of said reporter in said transgenic cells before said combining and after said combining, wherein
- i) a reduced level of expression of said reporter in said second sample compared to said first sample indicates the presence of TBI in said test sample,
- and
- ii) an increased level of expression of said reporter in said second sample compared to said first sample indicates the presence of TSI in said test sample.
Dependencies are inferred from the claim text.