Eight-Clone Humanized Antibody Panel for Differentiated Thyroid Cancer Recurrence Surveillance CLIA
Thyroglobulin (Tg) is a 660 kDa, dimeric glycoprotein produced exclusively by the follicular cells of the thyroid gland — a small, butterfly-shaped gland located near the throat — where it functions as the structural scaffold on which thyroxine (T4) and triiodothyronine (T3) are synthesized and stored, and is used entirely within the thyroid. Because Tg production is a functional property unique to thyroid tissue — and this property is retained by well-differentiated thyroid cancer cells — serum Tg behaves as a tissue-specific marker: after a total thyroidectomy combined with radioactive iodine remnant ablation, no thyroid tissue remains to produce Tg, so serum Tg should fall to a very low or undetectable level.
This biology makes Thyroglobulin the primary tumor marker for long-term surveillance of differentiated thyroid cancer (DTC), the most common form of thyroid malignancy. Any measurable or rising serum Tg after complete thyroid ablation signals persistent or recurrent disease, and serial Tg trend over time is used to guide the intensity of follow-up imaging and further treatment (Spencer CA, J Clin Endocrinol Metab 2004). A critical assay-design consideration is that approximately 20–25% of DTC patients carry circulating anti-Thyroglobulin autoantibodies (TgAb), which bind Tg and can cause a falsely low immunometric Tg result — which is why professional guidelines recommend measuring TgAb alongside every Tg result, using TgAb trend itself as a surrogate marker when TgAb is positive.
For IVD developers, Sekbio supplies a panel of eight humanized anti-Tg monoclonal clones — S01-tg-1H through S01-tg-8H — each targeting the full-length Tg protein, for capture/detection pair screening in CLIA sandwich immunoassay construction. Because Tg is a large, structurally complex dimeric glycoprotein, having multiple candidate clones available is central to identifying a well-matched, non-competing pair. All clones use a humanized IgG framework, and pair naturally with Sekbio's existing TSH, TPO, and TSHR antibody pairs for a complete thyroid function and autoimmunity panel.
Eight humanized anti-human Tg monoclonal clones for capture/detection pair screening in CLIA sandwich immunoassay development.
| Catalog No. | Product Name | Epitope |
|---|---|---|
| S01-tg-1H | Humanized anti-human Tg mAb | Full-length Tg protein |
| S01-tg-2H | Humanized anti-human Tg mAb | Full-length Tg protein |
| S01-tg-3H | Humanized anti-human Tg mAb | Full-length Tg protein |
| S01-tg-4H | Humanized anti-human Tg mAb | Full-length Tg protein |
| S01-tg-5H | Humanized anti-human Tg mAb | Full-length Tg protein |
| S01-tg-6H | Humanized anti-human Tg mAb | Full-length Tg protein |
| S01-tg-7H | Humanized anti-human Tg mAb | Full-length Tg protein |
| S01-tg-8H | Humanized anti-human Tg mAb | Full-length Tg protein |
All eight clones are humanized IgG raised against the full-length Tg protein. Contact info@sekbio.com for the recommended capture/detection pairing, full Certificate of Analysis (purity, concentration, buffer, storage), and MOQ pricing.
Engineered for the sensitivity required in post-ablation DTC recurrence monitoring and combined thyroid panel development.
Tg's large, structurally complex 660 kDa dimeric form makes identifying a well-matched, non-competing capture/detection pair harder than for a small analyte. Eight independent humanized clones give developers real options to screen for optimal sandwich performance.
All eight Tg clones use a humanized IgG framework rather than a murine one, reducing the risk of human anti-mouse antibody (HAMA) interference in CLIA analyzer applications compared with a conventional mouse monoclonal panel.
Matched for use alongside Sekbio's TSH, TPO, and TSHR antibody pairs, enabling a single-source thyroid function and autoimmunity panel on one CLIA platform.
All eight clones are raised against the full-length Tg protein rather than a truncated fragment, preserving the native 660 kDa dimeric epitope landscape that circulating patient Tg presents in a clinical sample.
Sekbio provides technical guidance on pairing the Tg antibody panel with a TgAb interference-detection step, addressing the approximately 20–25% of DTC patients whose autoantibodies can otherwise mask a true Tg result.
ISO 13485-compliant manufacturing in Shenzhen, China, with full Certificate of Analysis documentation available on request and OEM supply for production-volume CLIA kit manufacturing.
Thyroglobulin antibody panel validated for differentiated thyroid cancer diagnostics and post-treatment surveillance.
Serum Tg should be very low or undetectable after total thyroidectomy and radioactive iodine ablation. Serial CLIA measurement using a matched pair from Sekbio's eight-clone Tg panel supports the long-term follow-up schedule used to detect persistent or recurrent DTC.
Stimulated Tg — measured after thyroid hormone withdrawal or recombinant human TSH injection — is more sensitive than basal (suppressed) Tg for detecting small-volume residual disease and is commonly used at the initial post-treatment risk-stratification visit.
Because TgAb interferes with Tg measurement, IVD developers pair Tg with TgAb testing and often with TPO and TSHR antibodies for a comprehensive thyroid autoimmunity workup on the same platform.
Sekbio's ISO 13485-certified manufacturing and eight-clone humanized panel support OEM CLIA kit manufacturers preparing CE IVD and other regulatory submissions. Visit our Products page for the full endocrine raw material portfolio, or contact us to discuss OEM supply.
Technical and commercial questions from IVD R&D engineers and procurement teams.
Thyroglobulin (Tg) is a 660 kDa, dimeric glycoprotein produced exclusively by the follicular cells of the thyroid gland, where it serves as the structural scaffold for thyroid hormone synthesis and is used entirely within the thyroid. Because Tg is produced only by thyroid tissue (whether normal or malignant, since well-differentiated thyroid cancer retains this synthetic function), serum Tg is essentially undetectable after a total thyroidectomy and radioactive iodine remnant ablation. In patients with differentiated thyroid cancer (DTC), any measurable or rising serum Tg after this treatment sequence signals persistent or recurrent disease, making Tg the primary tumor marker for long-term DTC surveillance.
Sekbio supplies a panel of eight humanized anti-human Tg monoclonal antibodies for capture/detection pair screening: S01-tg-1H, S01-tg-2H, S01-tg-3H, S01-tg-4H, S01-tg-5H, S01-tg-6H, S01-tg-7H, and S01-tg-8H, each targeting the full-length Tg protein. Contact info@sekbio.com for the recommended pairing, full Certificate of Analysis, and MOQ pricing.
Because Tg is a large 660 kDa dimeric glycoprotein with a complex, heterogeneous epitope landscape, identifying two clones that bind non-overlapping sites without steric interference is central to sandwich immunoassay performance. Sekbio's eight-clone humanized panel gives IVD developers real options for screening the capture/detection pairing best suited to their CLIA platform, and the humanized IgG framework across all eight clones reduces the risk of human anti-mouse antibody (HAMA) interference compared with a murine-only panel.
Approximately 20–25% of differentiated thyroid cancer patients have circulating anti-Thyroglobulin autoantibodies (TgAb), which bind Tg and interfere with immunometric (sandwich) Tg assays — typically causing a falsely low or undetectable Tg result even when disease is present. Because TgAb can mask true Tg elevation, professional guidelines recommend measuring TgAb alongside every Tg result: a positive TgAb result means the Tg value must be interpreted with caution, and TgAb trend itself becomes a useful surrogate marker of disease activity in that scenario (Spencer CA, J Clin Endocrinol Metab 2004).
Basal (suppressed) Tg is measured while the patient is on standard thyroid hormone replacement therapy, which keeps TSH — and therefore any residual thyroid tissue's Tg output — suppressed. Stimulated Tg is measured after either thyroid hormone withdrawal or recombinant human TSH (rhTSH) injection, both of which raise TSH and maximize Tg secretion from any remaining thyroid or tumor tissue. Stimulated Tg testing is more sensitive for detecting small-volume residual or recurrent disease than basal Tg, and is commonly used at the initial post-treatment risk-stratification visit.
Yes. Sekbio is an ISO 13485-certified manufacturer supplying the eight-clone humanized Thyroglobulin antibody panel with full batch documentation and Certificate of Analysis to support CE IVD and other regulatory submissions. Sekbio also supplies antibody pairs for TSH, TPO, and TSHR for a complete thyroid function and autoimmunity panel. Contact info@sekbio.com to request datasheets or OEM pricing. Visit our Platforms page for antibody development and custom antigen expression services.
Request the full technical datasheet, recommended clone pairing, or discuss OEM supply for your thyroid cancer surveillance IVD development programme.