Anti-TSH Receptor Monoclonal Antibodies for Graves' Disease & Autoimmune Thyroid IVD Development
The Thyroid-Stimulating Hormone Receptor (TSHR) is a 764-amino acid, seven-transmembrane G-protein coupled receptor expressed on the basolateral surface of thyroid follicular cells. When bound by TSH from the pituitary, TSHR activates adenylate cyclase, stimulating the synthesis and secretion of thyroxine (T4) and triiodothyronine (T3). TSHR plays a central role in thyroid autoimmunity: in Graves' disease — the most common cause of hyperthyroidism globally — autoantibodies against TSHR (TSH Receptor Antibodies, TRAb) act as TSH agonists, causing unregulated thyroid stimulation.
For IVD assay development, anti-TSHR monoclonal antibodies are the key raw material in two assay formats: (1) competitive inhibition (TBII) assays, where a labelled anti-TSHR antibody competes with patient TRAb for binding to the coated TSHR antigen — providing a quantitative TRAb titre; and (2) direct sandwich TSHR immunoassays for research applications. The TSHR antigen (S01-TSHR-6) is used as the solid-phase capture component.
TRAb measurement is recommended by ATA, ETA, and AACE guidelines for the diagnosis of Graves' disease, assessment of relapse risk after antithyroid drug therapy, and monitoring during pregnancy (to evaluate neonatal TRAb transfer risk). Sekbio supplies both humanized and conventional mouse anti-TSHR antibodies to support diverse assay platform development.
Humanized and mouse anti-TSHR antibodies plus TSHR antigen for complete TRAb assay development.
| Catalog No. | Product Name | Format / Isotype | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| S01-TSHR-1H | Humanized Anti-TSHR Antibody | Humanized IgG1 | >95% SDS-PAGE | Competitive TBII / CLIA | +2°C to +8°C |
| S01-TSHR-2H | Humanized Anti-TSHR Antibody (High Conc.) | Humanized IgG1 (6.04 mg/mL) | >95% SDS-PAGE | Competitive TBII / CLIA / ELISA | +2°C to +8°C |
| S01-TSHR-4M | Mouse Anti-TSHR Monoclonal Antibody | Mouse IgG1 (2.6 mg/mL) | >95% SDS-PAGE | ELISA / CLIA / CMIA | +2°C to +8°C |
| S01-TSHR-6 | TSHR Recombinant Antigen (Protein) | Recombinant | >80% SDS-PAGE | Coating / Calibrator / Positive Control | −20°C ±2°C |
MOQ 1 mg. OEM quantities (10 mg–gram scale) available. Contact info@sekbio.com for bulk pricing and lot availability.
Designed for the high sensitivity and specificity required in Graves' disease diagnosis and relapse prediction.
S01-TSHR-2H combines a human IgG1 constant domain with the mouse variable region — reducing anti-species background in competitive assays and improving assay signal clarity in TBII format. Ideal for platforms that use human Fc-specific secondary detection systems.
All TSHR antibodies are affinity-purified from cell culture supernatants with >95% purity by SDS-PAGE. High purity reduces non-specific binding in competitive TBII assays, where background suppression is critical for accurate TRAb quantification at low positive levels.
S01-TSHR-6 recombinant TSHR antigen is the solid-phase coating partner for competitive TBII assay development. The matched antibody/antigen system ensures optimal competition efficiency and predictable inhibition curves for TRAb quantification against WHO reference standards.
Validated for ELISA, CLIA, CMIA, and Rapid Test/POCT formats. The panel supports both quantitative analyzer-based competitive immunoassay platforms and qualitative lateral flow strip development for point-of-care Graves' disease screening.
Manufactured under ISO 13485 quality management system with full batch documentation. Each lot undergoes appearance, purity, and binding activity QC before release. Certificate of Analysis provided with each shipment. 4-year shelf life from production date.
ISO 13485-compliant manufacturing in Shenzhen, China. MOQ 1 mg for R&D evaluation; gram-scale production supply for OEM manufacturing. Supports CE, NMPA, and FDA regulatory submissions with batch documentation for competitive TBII kit development.
Anti-TSHR antibodies used in TRAb competitive assay development for Graves' disease diagnosis and thyroid autoimmunity monitoring.
TRAb measurement by competitive TBII assay is the gold-standard serological test for Graves' disease diagnosis, recommended by ATA and ETA guidelines. The assay uses coated TSHR antigen (S01-TSHR-6) with labelled anti-TSHR antibody (S01-TSHR-1H or S01-TSHR-2H) competing against patient serum TRAb. A result >1.75 IU/L (by third-generation assay) is diagnostic for Graves' disease with >99% specificity. Sekbio's matched TSHR antibody/antigen system supports third-generation TBII kit development.
TRAb titre at the completion of antithyroid drug (ATD) therapy is the strongest predictor of Graves' disease relapse. Patients with TRAb >1.75 IU/L after 12–18 months of ATD have >70% relapse risk, while TRAb-negative patients have <20% risk. Serial TRAb monitoring during ATD informs decisions on therapy duration and definitive treatment (radioiodine or surgery). Quantitative CLIA assays using Sekbio TSHR antibodies support high-throughput monitoring.
Maternal TRAb crosses the placenta and can cause neonatal hyperthyroidism in 1–2% of Graves' disease pregnancies. ATA guidelines recommend TRAb measurement at 20–24 weeks gestation in pregnant women with active or past Graves' disease. High maternal TRAb (>3× upper reference limit) warrants foetal and neonatal monitoring. CLIA and ELISA TRAb assays using Sekbio TSHR antibody panel support antenatal screening kit development.
TRAb is elevated in Graves' disease but not in toxic multinodular goitre or toxic adenoma — making TSHR antibody assays valuable for differentiating the cause of hyperthyroidism without requiring radioiodine uptake scanning. OEM CLIA analyzer manufacturers and ELISA kit developers can integrate Sekbio's TSHR antibody panel with ISO 13485-compliant batch data. Visit our Products page for related thyroid biomarker raw materials including TSH antibodies.
Technical and commercial questions from IVD R&D engineers and procurement teams.
TSHR (TSH Receptor) is a G-protein coupled receptor on thyroid cells. In Graves' disease, patient autoantibodies (TRAb) bind TSHR as agonists, causing uncontrolled thyroid hormone production. Anti-TSHR monoclonal antibodies are used as raw materials in competitive TBII (TSH-binding inhibition) assays to detect and quantify patient TRAb, which is diagnostic for Graves' disease and predictive of relapse risk after antithyroid drug therapy.
Sekbio supplies: S01-TSHR-1H (humanized anti-TSHR mAb), S01-TSHR-2H (humanized, 6.04 mg/mL, human IgG1 constant / mouse IgG1 variable, >95% SDS-PAGE), S01-TSHR-4M (mouse IgG1, 2.6 mg/mL, >95% SDS-PAGE), and S01-TSHR-6 (TSHR recombinant antigen for coating and calibrator preparation). All available from MOQ 1 mg.
S01-TSHR-2H is humanized — combining a human IgG1 constant domain with the mouse variable region — which reduces anti-mouse background in competitive assays and is preferred for platforms using human Fc-specific detection. S01-TSHR-4M is a conventional mouse IgG1 monoclonal, suitable for standard ELISA and CLIA capture/detection. Both are >95% purity by SDS-PAGE and validated for the same platforms.
In a competitive TBII format: coat the microplate or magnetic bead with S01-TSHR-6 antigen; add labelled S01-TSHR-2H (or S01-TSHR-1H) together with patient serum. Patient TRAb and the labelled antibody compete for TSHR binding sites. Signal inhibition is proportional to TRAb concentration. Calibrate against WHO International Standard for anti-thyroid antibodies. Contact info@sekbio.com for TBII assay protocol and optimisation guidance.
All TSHR antibodies (S01-TSHR-1H, -2H, -4M): store at +2°C to +8°C; avoid multiple freeze/thaw cycles. Buffer: PBS pH 7.2. Shelf life: 4 years from production date. S01-TSHR-6 antigen: store at −20°C ±2°C. MOQ 1 mg; OEM gram-scale quantities available.
Yes. Sekbio's TSHR antibodies are manufactured under ISO 13485 QMS with full batch documentation suitable for CE-IVD regulatory submissions. Custom conjugation (HRP, acridinium, biotin, colloidal gold) of TSHR antibodies is available through Sekbio's service platform. Visit our Platforms page for antibody development and conjugation services, or contact info@sekbio.com.
Request the full technical datasheet, TBII assay protocol, or discuss OEM supply with our team.