Human Chorionic Gonadotropin — Anti-Beta-hCG Antibodies for Pregnancy LFA & CLIA Development
Human Chorionic Gonadotropin (hCG) is a heterodimeric glycoprotein hormone composed of an alpha subunit (common to FSH, LH, and TSH) and a unique beta subunit (β-hCG) that confers pregnancy specificity. hCG is produced by trophoblast cells from 6–8 days post-implantation, with serum levels doubling every 48–72 hours in the first trimester, reaching peak concentrations of 10,000–200,000 mIU/mL at 10–12 weeks gestation.
hCG is the most universally measured IVD analyte: globally, hundreds of millions of pregnancy tests — home urine LFAs, clinical qualitative strips, and quantitative serum CLIA — are performed annually. The beta subunit specificity of anti-hCG antibodies is essential to avoid cross-reactivity with the LH mid-cycle surge (which peaks at ~40–200 IU/L) that would cause false-positive results in non-pregnant women.
Sekbio supplies a complete HCG antibody system: QTAG01 (capture), QTAG03 (detection), an HRP-conjugated beta-hCG mAb for ELISA development, and native hCG antigen for calibrator preparation — enabling a full-spectrum pregnancy immunoassay reagent system from a single ISO 13485-certified source.
Complete HCG antibody and antigen system for LFA, CLIA, and ELISA pregnancy test development from a single source.
| Catalog No. | Product Name | Target | Role | Format | Purity | Platforms | Storage |
|---|---|---|---|---|---|---|---|
| QTAG01 | Mouse Anti-β-hCG mAb (Capture) | β-hCG | Capture | Mouse IgG | >90% SDS-PAGE | LFA / CLIA | +2°C to +8°C |
| QTAG03 | Mouse Anti-β-hCG mAb (Detection) | β-hCG | Detection | Mouse IgG | >90% SDS-PAGE | LFA / CLIA | +2°C to +8°C |
| HRP-β-hCG mAb | HRP-Conjugated Anti-β-hCG mAb | β-hCG | Detection (ELISA) | HRP Conjugate | >90% SDS-PAGE | ELISA | +2°C to +8°C |
| Native hCG Ag | Native Human hCG Antigen | N/A | Calibrator / Standard | Native Protein | >85% SDS-PAGE | Calibration | −20°C ±2°C |
All antibodies supplied in PBS pH 7.2–7.4. MOQ 1 mg. OEM quantities (10 mg–gram scale) available. Contact info@sekbio.com for bulk pricing and lot availability.
Engineered for the beta-subunit specificity, early-detection sensitivity, and batch consistency required in global pregnancy rapid test manufacturing.
QTAG01 and QTAG03 target the unique beta subunit of hCG, with minimal cross-reactivity to LH, FSH, and TSH which share the identical alpha subunit. Beta-specificity eliminates false-positive results from the LH mid-cycle surge (>40 IU/L), ensuring true pregnancy-specific detection in urine and serum samples.
The QTAG01 / QTAG03 pair achieves 25 mIU/mL sensitivity in LFA format with colloidal gold particles — equivalent to detection at 10–12 days post-conception, before the expected missed period. This early detection sensitivity meets WHO and international standards for home pregnancy test (HPT) performance.
Sekbio supplies capture antibody (QTAG01), detection antibody (QTAG03), HRP-conjugated mAb for ELISA, and native hCG antigen for calibration — a complete pregnancy immunoassay reagent system from a single ISO 13485-certified source. Simplifies development, QC, and regulatory submissions.
HCG is measured in both urine (home pregnancy tests, clinical qualitative strips) and serum (quantitative CLIA for early pregnancy monitoring and trophoblastic disease). QTAG01 / QTAG03 are validated for performance in both matrices, supporting manufacturers targeting consumer LFA and clinical analyzer markets.
All HCG antibodies are manufactured under ISO 13485 QMS with full batch documentation, Certificate of Analysis, and inter-batch CV <10%. Suitable for CE-marked pregnancy rapid tests, FDA 510(k) OTC home pregnancy tests, and NMPA-registered clinical hCG assays.
Sekbio supplies HCG antibodies at gram-scale for high-volume OEM rapid test manufacturers in Africa, Southeast Asia, the Middle East, and South America. MOQ 1 mg for R&D; production quantities shipped with full CoA documentation for local regulatory submissions.
HCG antibody pair validated for pregnancy rapid tests, quantitative serum hCG assays, and OEM kit development across multiple formats.
Home pregnancy tests are among the highest-volume IVD products globally. QTAG01 / QTAG03 are specifically validated for colloidal gold LFA format, enabling OEM manufacturers to develop urine hCG qualitative tests meeting WHO 25 mIU/mL sensitivity requirements for home use. Sekbio supplies these antibodies to rapid test manufacturers in Africa and Southeast Asia targeting high-volume consumer pregnancy test markets.
Quantitative serum hCG doubling time (every 48–72 hours in normal pregnancy) is the standard clinical test for early pregnancy viability, ectopic pregnancy diagnosis, and gestational trophoblastic disease monitoring. CLIA assays using QTAG01 / QTAG03 support development of analyzer reagents measuring hCG from <1 mIU/mL to >200,000 mIU/mL in a single-tube, wide-range sandwich format.
hCG is the definitive biomarker for gestational trophoblastic disease (GTD) including hydatidiform mole, choriocarcinoma, and other trophoblastic neoplasia. Serial hCG monitoring after molar evacuation or chemotherapy (methotrexate, actinomycin D) guides treatment decisions and disease remission assessment. Ultra-sensitive CLIA assays using Sekbio's HCG antibody pair support GTD monitoring across the full hCG range.
IVD manufacturers developing CE-marked, FDA-cleared, or locally registered pregnancy tests can source QTAG01, QTAG03, and native hCG antigen from Sekbio with ISO 13485 batch documentation for regulatory submissions. Sekbio's Rapid Test page also offers finished pregnancy test products for private label. Contact info@sekbio.com for OEM options.
Technical and commercial questions from IVD R&D engineers and procurement teams.
Human Chorionic Gonadotropin (hCG) is produced by trophoblast cells from 6–8 days post-implantation, doubling every 48–72 hours in early pregnancy. The unique beta subunit enables pregnancy-specific detection. hCG is the gold-standard pregnancy biomarker, measured in billions of home and clinical tests annually worldwide.
Sekbio supplies: QTAG01 (mouse IgG capture, anti-β-hCG), QTAG03 (mouse IgG detection, anti-β-hCG), HRP-conjugated β-hCG mAb (for ELISA), and native hCG antigen (for calibrators). All antibodies available from MOQ 1 mg with ISO 13485-compliant lot documentation.
QTAG01 / QTAG03 are validated for LFA (colloidal gold rapid test, 25 mIU/mL sensitivity) and CLIA (quantitative serum hCG analyzer reagents). The HRP-conjugated mAb supports ELISA development. All formats use beta-hCG specific antibodies to avoid LH cross-reactivity.
hCG shares an identical alpha subunit with LH, FSH, and TSH. Without beta-subunit specificity, assays would produce false-positive results from the monthly LH surge (>40 IU/L at ovulation) in non-pregnant women. QTAG01 and QTAG03 target the unique β subunit, ensuring pregnancy-specific detection.
The QTAG01 / QTAG03 pair achieves 25 mIU/mL sensitivity in LFA format with colloidal gold — equivalent to detection at 10–12 days post-conception, meeting WHO sensitivity requirements for home pregnancy tests. In CLIA format, sensitivity from <1 mIU/mL supports early pregnancy monitoring and trophoblastic disease management.
Yes. Sekbio supplies QTAG01 and QTAG03 at gram scale for high-volume OEM rapid test manufacturers. We have experience exporting HCG antibody pairs to manufacturers in Africa, Southeast Asia, the Middle East, and South America. Native hCG antigen is also available. Contact info@sekbio.com or visit our Rapid Test page for finished product options.
Request the full technical datasheet, HCG antibody pair specifications, or discuss OEM supply with our team.