Thyroid-Stimulating Hormone Monoclonal Antibody for Third-Generation Thyroid Function Immunoassay Development
Thyroid-Stimulating Hormone (TSH), also called thyrotropin, is a 28 kDa glycoprotein heterodimer secreted by the anterior pituitary gland. TSH binds to receptors on thyroid follicular cells, stimulating the synthesis and secretion of thyroxine (T4) and triiodothyronine (T3) via a classic negative feedback loop. Because TSH responds exponentially to small changes in circulating thyroid hormone — a 2-fold change in free T4 produces a 100-fold change in TSH — TSH is the most sensitive indicator of thyroid function and the first-line diagnostic test for all thyroid disorders.
The normal TSH reference range is approximately 0.27–4.2 mIU/L (adult), though trimester-specific ranges apply in pregnancy. Suppressed TSH (<0.1 mIU/L) indicates hyperthyroidism or excessive thyroid hormone replacement; elevated TSH (>4.5 mIU/L) indicates hypothyroidism. Third-generation TSH assays (functional sensitivity <0.02 mIU/L) are required to reliably distinguish suppressed from low-normal TSH in patients on thyroid-suppressive therapy for thyroid cancer.
TSH immunoassay is one of the highest-volume thyroid tests globally, with annual test volume exceeding 200 million worldwide. Sekbio's matched TSH antibody pair is designed for both high-throughput CLIA analyzer platforms and LFA POCT rapid test development.
Matched capture and detection antibodies for TSH sandwich immunoassay development across CLIA, LFA, and ELISA platforms.
| Catalog No. | Product Name | Source | Concentration | Purity | Intended Use | Storage |
|---|---|---|---|---|---|---|
| TSH-Ab-P01 | Mouse Anti-TSH mAb (Capture) | Mouse mAb | ≥3 mg/mL | ≥90% HPLC | Capture — LFA / CLIA / ELISA | −20°C |
| TSH-Ab-P03 | Mouse Anti-TSH mAb (Detection) | Mouse mAb | 3.91 mg/mL | ≥90% HPLC | Detection — LFA / CLIA / ELISA | −20°C |
Both antibodies supplied in PBS pH 7.4. MOQ 1 mg. Avoid multiple freeze/thaw cycles. Contact info@sekbio.com for lot availability, working concentration recommendations, and conjugation specifications.
Engineered for the high sensitivity and broad dynamic range required in third-generation TSH clinical testing.
The matched TSH-Ab-P01 / TSH-Ab-P03 pair is optimised for CLIA platforms achieving functional sensitivity <0.02 mIU/L — the third-generation threshold required for reliable detection of TSH suppression in hyperthyroidism and thyroid cancer monitoring. This sensitivity level distinguishes TSH <0.1 mIU/L from undetectable in thyroid-suppressive therapy.
TSH-Ab-P01 (capture) and TSH-Ab-P03 (detection) are pre-screened to bind spatially distinct epitopes on the TSH molecule — one targeting the alpha subunit shared with LH/FSH/hCG, and one targeting the TSH-specific beta subunit — ensuring assay specificity against cross-reactive glycoprotein hormones.
ISO 13485 QMS manufacturing with inter-batch CV <10%. Each lot undergoes HPLC purity (≥90%) and concentration verification before release, ensuring assay calibration stability and minimising lot-to-lot recalibration frequency on automated CLIA analyzers.
Validated for lateral flow assay (qualitative/semi-quantitative POCT), CLIA (quantitative high-throughput), and ELISA formats. Mouse monoclonal antibodies support direct colloidal gold conjugation for LFA cassette development and acridinium ester labelling for CLIA reagents.
Neonatal TSH screening for congenital hypothyroidism — the most common preventable cause of intellectual disability — requires high-sensitivity TSH assay in dried blood spot (DBS) samples. Sekbio TSH antibody pair's high affinity supports the low-volume, high-sensitivity requirements of newborn screening programs.
ISO 13485-compliant manufacturing. MOQ 1 mg for R&D; gram-scale supply for OEM production. Certificate of Analysis, lot traceability, and MSDS provided. Regulatory documentation support for CE IVD, NMPA, and WHO prequalification submissions.
TSH antibody pair for thyroid screening, disease management, pregnancy monitoring, and OEM assay development.
TSH >4.5 mIU/L with low free T4 confirms primary hypothyroidism, affecting ~5% of adults (subclinical: 10%). Hashimoto's thyroiditis — the most common autoimmune thyroid disease in iodine-sufficient countries — typically presents with elevated TSH and positive TPO antibodies. Sekbio TSH antibody pair supports quantitative CLIA assay development for population screening programs and laboratory diagnosis workflows.
TSH <0.1 mIU/L (suppressed) with elevated free T4/T3 confirms hyperthyroidism. Graves' disease — the most common cause — affects ~1–2% of women. Third-generation TSH assay distinguishes overt hyperthyroidism (TSH undetectable, <0.01 mIU/L) from subclinical hyperthyroidism (TSH 0.01–0.4 mIU/L) using the functional sensitivity achieved with the Sekbio TSH antibody pair.
Trimester-specific TSH reference ranges in pregnancy (typically lower than non-pregnant ranges) require high-precision TSH measurement. Neonatal TSH screening for congenital hypothyroidism (1:2,000–4,000 births) uses DBS TSH quantification. The Sekbio TSH antibody pair supports both clinical laboratory analyzers and newborn screening program assay development.
Post-thyroidectomy TSH suppressive therapy (target TSH <0.1 mIU/L for high-risk DTC) requires third-generation TSH measurement. Sekbio's antibody pair supports ultra-sensitive TSH CLIA reagent development for differentiated thyroid cancer (DTC) monitoring. OEM kit manufacturers in Europe, Korea, and China can integrate Sekbio TSH antibody pairs with ISO 13485 batch data for multi-market regulatory submissions.
Thyroid-Stimulating Hormone (TSH) is secreted by the anterior pituitary and regulates thyroid hormone production via negative feedback. Because TSH responds exponentially to small changes in circulating thyroid hormone (a 2-fold change in free T4 causes a ~100-fold change in TSH), it is far more sensitive than T3 or T4 measurement alone. TSH is the first-line thyroid function test recommended by ATA, ETA, and BTA guidelines for hypothyroidism screening, hyperthyroidism diagnosis, and monitoring of thyroid hormone replacement therapy.
Sekbio supplies: TSH-Ab-P01 (Mouse anti-TSH mAb, capture, ≥3 mg/mL, ≥90% HPLC purity, PBS pH 7.4, −20°C) and TSH-Ab-P03 (Mouse anti-TSH mAb, detection, 3.91 mg/mL, ≥90% HPLC purity, PBS pH 7.4, −20°C). Both are validated for LFA, CLIA, and ELISA. MOQ 1 mg.
Validated for LFA (lateral flow assay), CLIA (chemiluminescence immunoassay), and ELISA. The antibody pair supports development of both POCT qualitative/semi-quantitative TSH tests and high-throughput quantitative CLIA assays for automated laboratory analyzers.
The TSH-Ab-P01 / TSH-Ab-P03 pair is optimised for third-generation CLIA sensitivity (functional sensitivity <0.02 mIU/L). Contact info@sekbio.com for detailed LOD, working concentration, and S/N ratio data in CLIA sandwich format.
Both TSH antibodies are purified with ≥90% purity by HPLC. Mouse monoclonal antibodies in PBS pH 7.4. ISO 13485 QMS manufacturing with batch-to-batch CV <10%. CoA provided with every shipment.
Store at −20°C for long-term storage (up to 2 years); at +2°C to +8°C for short-term use up to 30 days. Avoid multiple freeze/thaw cycles. Centrifuge before opening. Contact info@sekbio.com for aliquoting recommendations or visit our Products page for the full IVD antibody catalog.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply with our team.