Alpha-Fetoprotein Monoclonal Antibody for Liver Cancer & HCC Immunoassay Development
Alpha-Fetoprotein (AFP) is a 70 kDa glycoprotein produced predominantly by the fetal liver, yolk sac, and gastrointestinal tract during fetal development. In healthy adults, serum AFP is normally below 10 ng/mL. Elevated AFP is the most widely used serum biomarker for hepatocellular carcinoma (HCC) — the sixth most common cancer and the third leading cause of cancer-related death worldwide.
For IVD immunoassay development, AFP quantification requires a matched antibody pair recognising non-overlapping epitopes, enabling sensitive sandwich CLIA or ELISA detection across the clinically relevant 1–10,000 ng/mL range. Sekbio supplies three AFP antibody catalog numbers — two monoclonal antibodies for capture and detection, plus a recombinant human AFP antigen for calibrator preparation.
AFP testing is indicated for HCC screening in high-risk populations (chronic hepatitis B/C, liver cirrhosis), monitoring treatment response after surgery or ablation, and as part of the AFP/AFP-L3/DCP triple panel for enhanced HCC diagnostic accuracy.
Capture antibody, detection antibody, and recombinant antigen for a complete AFP immunoassay system.
| Catalog No. | Product Name | Species / Format | Isotype | Purity | Intended Use | Storage |
|---|---|---|---|---|---|---|
| S01-AFP-1M | Mouse Anti-AFP mAb (Capture) | Mouse | IgG2a | >90% SEC-HPLC | Capture — CLIA / ELISA | +2°C to +8°C |
| S01-AFP-2M | Mouse Anti-AFP mAb (Detection) | Mouse | IgG | >90% SEC-HPLC | Detection — CLIA / ELISA | +2°C to +8°C |
| HP174-3 | Recombinant Human AFP Antigen | Eukaryotic | N/A | >80% SDS-PAGE | Calibrator / Positive Control | −20°C ±2°C |
All products supplied in 20 mM PB, 150 mM NaCl, pH 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 high sensitivity, wide range, and batch consistency required in clinical HCC screening.
HA174-1M and S01-AFP-2M are pre-screened to bind distinct, non-overlapping epitopes on the AFP molecule, enabling efficient sandwich immunoassay formation and maximising signal output in CLIA and ELISA formats.
Affinity-purified from cell culture supernatants with SEC-HPLC purity >90% and aggregation <5%. High purity reduces non-specific binding in immunoassay backgrounds, improving signal-to-noise ratios and assay specificity.
Manufactured under ISO 13485 QMS with inter-batch CV <10% across production lots. Each batch is released only after appearance, purity, and molecular weight QC, ensuring reagent reliability for OEM production supply.
HP174-3 recombinant human AFP antigen (68.1 kDa, eukaryotic expression, pI 5.87) is available for calibrator preparation, assay validation, and positive control manufacture — simplifying the full assay development workflow.
Validated for CLIA and ELISA sandwich formats. The antibody pair supports both analyzer-based quantitative CLIA platforms and plate-based ELISA kits, offering flexibility for different IVD product lines.
ISO 13485-compliant manufacturing in Shenzhen, China. MOQ 1 mg for R&D evaluation; gram-scale production supply for OEM manufacturing. Certificate of Analysis provided with every lot shipped globally.
AFP antibody pair validated for oncology diagnostics, monitoring, and OEM immunoassay development.
AFP is the primary serum biomarker for HCC surveillance in cirrhotic patients and chronic hepatitis B/C carriers. An AFP threshold >20 ng/mL triggers imaging follow-up; >400 ng/mL is considered diagnostic for HCC in appropriate clinical context. Sensitive CLIA assays using this antibody pair support early detection in high-incidence regions including China, Sub-Saharan Africa, and Southeast Asia.
Serial AFP quantification guides HCC treatment response assessment after hepatic resection, radiofrequency ablation, transarterial chemoembolisation (TACE), and systemic therapies. A post-treatment AFP decline >50% from baseline correlates with favourable prognosis. Sekbio's antibody pair wide-range performance supports both low-level monitoring (<20 ng/mL) and high-level measurement (>1,000 ng/mL) in a single assay.
Maternal serum AFP measured at 15–20 weeks gestation forms part of second-trimester aneuploidy screening panels (quad screen). Elevated AFP indicates neural tube defects (anencephaly, open spina bifida); low AFP is associated with Down syndrome. Quantitative ELISA using Sekbio AFP antibody pair supports prenatal screening kit development.
AFP is elevated in non-seminomatous germ cell tumours (NSGCT) of the testis and ovary, serving as a staging, prognosis, and relapse biomarker per IGCCCG guidelines. OEM CLIA analyzer manufacturers and ELISA kit developers can integrate Sekbio's AFP antibody pair with ISO 13485-compliant batch data for regulatory submissions to CE, FDA, and NMPA.
Technical and commercial questions from IVD R&D engineers and procurement teams.
Alpha-Fetoprotein (AFP) is a 70 kDa glycoprotein produced primarily by the fetal liver. In adults, elevated serum AFP above 20 ng/mL is the principal biomarker for hepatocellular carcinoma (HCC). AFP is also elevated in testicular germ cell tumours and during pregnancy. Quantitative AFP immunoassay is recommended by AASLD, EASL, and APASL guidelines for HCC surveillance in high-risk patients with cirrhosis or chronic hepatitis B/C.
Sekbio supplies: S01-AFP-1M (Mouse IgG2a capture), S01-AFP-2M (Mouse IgG detection), and HP174-3 (Recombinant human AFP antigen, 68.1 kDa, eukaryotic expression) for calibrator preparation. All are available from MOQ 1 mg with 3-year shelf life.
Sekbio AFP antibodies are validated for CLIA (chemiluminescence immunoassay) and ELISA (enzyme-linked immunosorbent assay) sandwich formats. The matched pair is pre-screened for non-overlapping epitopes, enabling high-sensitivity quantification across the 1–10,000 ng/mL clinical range.
All AFP antibodies are affinity-purified from cell culture supernatants with purity >90% by SEC-HPLC. Each lot undergoes appearance, purity, and molecular weight testing before release. Manufactured under ISO 13485 QMS with inter-batch CV <10%.
MOQ is 1 mg for R&D evaluation. OEM production quantities from 10 mg to gram scale are available. Storage: capture and detection antibodies are stable at +2°C to +8°C for up to 1 month; −20°C for long-term storage. Avoid repeated freeze/thaw cycles. AFP antigen (HP174-3) requires −20°C ±2°C storage.
Yes. Sekbio's antibody development platform covers hybridoma screening, recombinant antibody engineering, and CHO stable cell line establishment. Custom AFP antibodies for lateral flow assay (LFA) colloidal gold conjugation or fluorescence immunoassay (FIA) can be developed in 8–12 weeks. Contact info@sekbio.com to discuss your requirements or visit our Platforms page.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply with our team.