Thyroid Peroxidase Monoclonal Antibody for Anti-TPOAb Immunoassay Development
Thyroid Peroxidase (TPO) is a ~105 kDa glycosylated heme-containing enzyme anchored to the apical plasma membrane of thyroid follicular cells. TPO catalyses two key reactions in thyroid hormone biosynthesis: the oxidation of iodide to iodine (organification) and the coupling of iodotyrosines to form thyroxine (T4) and triiodothyronine (T3). As the dominant autoantigen in thyroid autoimmunity, TPO is the target of anti-TPO autoantibodies (anti-TPOAb) produced by autoreactive B cells in autoimmune thyroid disease.
For IVD immunoassay development, anti-TPOAb quantification is the most important serological test in thyroid autoimmunity. Anti-TPOAb are elevated in >90% of Hashimoto's thyroiditis patients and in 75–80% of Graves' disease patients. ATA and ETA guidelines recommend anti-TPOAb as the first-line serological test for suspected autoimmune thyroid disease, for evaluating subclinical hypothyroidism progression risk, and for monitoring thyroid function in patients receiving checkpoint inhibitor immunotherapy or lithium therapy.
TPO immunoassays use the recombinant TPO antigen as the capture/coating antigen to capture patient anti-TPOAb from serum, followed by labelled anti-human IgG detection. Sekbio supplies anti-TPO monoclonal antibodies (TPO-W421) for positive control preparation and matched recombinant TPO antigen for assay calibration, supporting CLIA and FIA anti-TPOAb kit development.
Anti-TPO monoclonal antibody and recombinant TPO antigen for complete anti-TPOAb assay development.
| Catalog No. | Product Name | Species / Format | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| TPO-W421 | Mouse Anti-TPO Monoclonal Antibody | Mouse | >90% SEC-HPLC | Positive Control / Assay Development — CLIA, FIA | +2°C to +8°C |
| TPO Antigen | Recombinant Human TPO Antigen | Eukaryotic / Recombinant | >80% SDS-PAGE | Coating / Capture / Calibrator | −20°C ±2°C |
MOQ 1 mg. OEM quantities (10 mg–gram scale) available. Contact info@sekbio.com for bulk pricing and current lot availability.
Optimised for the sensitivity and specificity required in anti-TPOAb quantification for Hashimoto's and Graves' disease diagnostics.
TPO-W421 mouse anti-TPO mAb serves as a surrogate positive control and calibration reference for anti-TPOAb assay development and kit quality control. Its defined TPO-binding activity provides a reproducible reference point independent of patient serum variability.
The paired recombinant human TPO antigen presents the immunodominant regions A and B of the TPO extracellular domain — the primary targets of patient anti-TPOAb. High-quality coating antigen ensures efficient capture of both IgG1 and IgG4 subclass anti-TPOAb from clinical samples.
Products are validated for chemiluminescence immunoassay (CLIA) analyzer platforms and fluorescence immunoassay (FIA) point-of-care formats. Functional testing confirms appropriate reactivity with the TPO antigen across both platform types.
Manufactured under ISO 13485 QMS with inter-batch CV <10%. Each lot is released only after full QC including appearance, purity by SEC-HPLC, and functional binding activity verification. Complete Certificate of Analysis provided with every shipment.
TPO antibody and antigen are available alongside Sekbio's TSHR antibody panel (S01-TSHR-1H/2H/4M) and TSH antibodies, enabling IVD developers to source complete thyroid autoimmunity and thyroid function raw material panels from a single ISO 13485 certified supplier.
ISO 13485-compliant manufacturing in Shenzhen, China. MOQ 1 mg for R&D; gram-scale production supply for OEM kit manufacturing. Supports CE-IVD, NMPA, and FDA regulatory submissions with full batch documentation and COA.
TPO antibody and antigen for anti-TPOAb assay development across autoimmune thyroid disease diagnostics.
Hashimoto's thyroiditis (chronic lymphocytic thyroiditis) is the most common cause of hypothyroidism in iodine-sufficient countries, affecting ~10% of women. Anti-TPOAb are elevated in >90% of Hashimoto's patients, making anti-TPOAb quantification the primary serological test for diagnosis. Clinically significant anti-TPOAb is typically >35 IU/mL; levels >100–500 IU/mL are highly specific for autoimmune thyroiditis. Quantitative CLIA assays using Sekbio TPO antigen support accurate Hashimoto's diagnosis and disease monitoring.
In subclinical hypothyroidism (elevated TSH, normal FT4), anti-TPOAb positivity is a strong predictor of progression to overt hypothyroidism — 4.3% per year vs 2.1% per year in anti-TPOAb-negative patients (Whickham Survey data). ATA guidelines recommend anti-TPOAb testing in all patients with subclinical hypothyroidism to inform levothyroxine therapy decisions. CLIA anti-TPOAb assays using Sekbio TPO products support this risk stratification application.
Anti-TPOAb positivity in the first trimester predicts postpartum thyroiditis in 30–50% of positive women. Positive anti-TPOAb is also associated with increased miscarriage risk and impaired IVF outcomes. ATA recommends anti-TPOAb screening in women with recurrent pregnancy loss and in hypothyroid pregnant women. Quantitative anti-TPOAb measurement supports obstetric risk stratification and prenatal monitoring kit development.
Anti-TPOAb is commonly assayed as part of a thyroid autoimmunity panel alongside anti-TgAb (thyroglobulin antibody) and TRAb (TSHR antibody), providing a comprehensive view of thyroid autoimmune status. OEM CLIA analyzer manufacturers can integrate Sekbio's TPO antibody/antigen system with ISO 13485-compliant batch data. Visit our Products page for related thyroid biomarkers, or contact our team for panel pricing.
Technical and commercial questions from IVD R&D engineers and procurement teams.
Thyroid Peroxidase (TPO) is the primary autoantigen in autoimmune thyroid disease. Anti-TPO autoantibodies (anti-TPOAb) are elevated in >90% of Hashimoto's thyroiditis and 75–80% of Graves' disease patients, making anti-TPOAb the first-line serological marker for thyroid autoimmunity. Anti-TPOAb testing is recommended by ATA and ETA guidelines for diagnosing autoimmune thyroid disease, assessing subclinical hypothyroidism progression risk, and monitoring pregnancy-related thyroid risks.
Sekbio supplies: TPO-W421 (mouse anti-TPO monoclonal antibody for positive control preparation and assay development in CLIA and FIA formats) and recombinant human TPO antigen for solid-phase coating, calibrator, and positive control preparation. All products available from MOQ 1 mg.
Sekbio TPO antibodies are validated for CLIA (chemiluminescence immunoassay) and FIA (fluorescence immunoassay) formats. Functional testing confirms appropriate antigen-binding activity for both analyzer-based quantitative platforms and point-of-care fluorescence readers.
In a standard anti-TPOAb bridge assay or indirect assay format, the recombinant TPO antigen is used as both the solid-phase capture antigen and the detection antigen (typically labelled with acridinium ester for CLIA). Patient anti-TPOAb binds the capture TPO antigen; the labelled detection TPO antigen then binds the captured antibody, generating a signal proportional to anti-TPOAb concentration. The TPO-W421 monoclonal antibody serves as a surrogate positive control for lot-to-lot QC.
MOQ is 1 mg for R&D evaluation; OEM production quantities from 10 mg to gram scale available. TPO-W421 antibody: +2°C to +8°C short-term; −20°C long-term. TPO antigen: −20°C ±2°C. Avoid repeated freeze/thaw cycles. Shelf life: 3 years from manufacturing date.
Yes. Sekbio offers a comprehensive thyroid biomarker raw material portfolio including TSH antibody pairs, TSHR antibody panel (S01-TSHR-1H/2H/4M/6), TPO antibody and antigen, and free T3/T4 antibody pairs. This enables OEM IVD manufacturers to source a complete thyroid function and autoimmunity panel from one ISO 13485 certified supplier. Contact info@sekbio.com for panel quotes or visit our Platforms page.
Request the full technical datasheet, TPO antigen specifications, or discuss OEM supply with our team.