Carcinoembryonic Antigen Monoclonal Antibody for Colorectal Cancer & Multi-Cancer Immunoassay Development
Carcinoembryonic Antigen (CEA) is a 200 kDa glycoprotein member of the immunoglobulin superfamily, encoded by the CEACAM5 gene. In healthy adults serum CEA is normally <5 ng/mL (non-smokers) or <10 ng/mL (smokers). CEA is the most widely used serum biomarker for colorectal cancer (CRC) — the third most common cancer globally — and is also elevated in lung adenocarcinoma, breast cancer, gastric cancer, and pancreatic cancer.
For IVD sandwich immunoassay development, CEA quantification requires a matched antibody pair where the capture and detection antibodies recognise spatially distinct, non-overlapping epitopes on the CEA molecule. Sekbio's multi-species design (Mouse IgG capture + Sheep IgG detection) minimises heterophilic antibody interference, a common source of false-positive CEA results in clinical immunoassays.
CEA measurement is recommended by ASCO and ESMO guidelines for CRC post-surgical monitoring, adjuvant chemotherapy response assessment, and recurrence surveillance. A doubling of CEA from nadir — even within the normal range — is considered clinically significant for relapse detection.
Capture antibody, detection antibody, and CHO-expressed recombinant CEA antigen for a complete immunoassay system.
| Catalog No. | Product Name | Species / Source | Isotype | Purity | Intended Use | Storage |
|---|---|---|---|---|---|---|
| S01-CEA-3M | Mouse Anti-Human CEA mAb (Capture) | Mouse | IgG | >90% SEC-HPLC | Capture — CLIA / ELISA / LFA | +2°C to +8°C |
| S01-CEA-4S | Recombinant Sheep Anti-Human CEA mAb (Detection) | Sheep (Recombinant) | IgG | >90% SEC-HPLC | Detection — CLIA / ELISA / LFA | +2°C to +8°C |
| S01-CEA-3 | Recombinant Human CEA Antigen | CHO Expression | N/A | >90% SDS-PAGE | Calibrator / Positive Control | −20°C ±2°C |
CEA antigen (S01-CEA-3): 72.9 kDa, pI 5.82, CHO expression. MOQ 1 mg. OEM gram-scale supply available. Contact info@sekbio.com for pricing.
Engineered for clinical-grade CEA quantification with multi-species design to minimise interference.
Mouse capture + Sheep detection antibody design significantly reduces heterophilic antibody (HAMA) interference compared to same-species pairs, decreasing the incidence of false-positive results in CLIA clinical analyzers — a known challenge in CEA immunoassays.
S01-CEA-3 recombinant CEA antigen (72.9 kDa, CHO expression) maintains native glycosylation patterns critical for antibody recognition, ensuring calibrator preparations accurately reflect patient sample behaviour in clinical CEA immunoassays.
ISO 13485 QMS manufacturing with inter-batch CV <10%. Each production lot undergoes SEC-HPLC purity, molecular weight, and appearance testing before release, ensuring consistent assay performance across reagent lots for OEM production.
CEA antibody pair validated for CLIA, ELISA, and lateral flow assay (LFA) formats, offering flexibility for both high-throughput laboratory analyzers and POCT rapid test development targeting the 1–1,000 ng/mL clinical range.
The S01-CEA-4S recombinant Sheep IgG detection antibody offers superior stability compared to conventional polyclonal antibody preparations, with consistent epitope specificity across manufacturing batches essential for long-term OEM production continuity.
ISO 13485-compliant manufacturing in Shenzhen, China. MOQ 1 mg for assay development; gram-scale production supply for OEM kit manufacturers. Certificate of Analysis and regulatory support documentation available for CE and NMPA submissions.
CEA antibody pair for oncology diagnostics, multi-cancer monitoring, and OEM immunoassay development.
CEA is the primary biomarker for CRC recurrence surveillance per ASCO and ESMO guidelines. Post-resection CEA every 3–6 months for 5 years detects approximately 60% of recurrences before symptom onset. A rising CEA trend — even within normal range — triggers imaging workup. Sekbio's CEA antibody pair supports the high-sensitivity, wide-range CLIA assay format required for clinical recurrence monitoring.
CEA is elevated in ~40–70% of lung adenocarcinomas and is a component of multi-tumour marker panels alongside AFP, CA125, CA199, NSE, and CYFRA21-1 on CLIA analyzer platforms. Sekbio CEA antibody pair is compatible with multi-analyte CLIA reagent manufacturing workflows used by diagnostic analyzer OEM customers in Europe, North America, and Korea.
CEA is used adjunctively with CA15-3 in breast cancer monitoring and with CA199 in gastric/pancreatic cancer. Elevated CEA (>5 ng/mL) combined with CA199 has sensitivity of ~70% for pancreatic cancer. The Sekbio CEA antibody pair wide dynamic range supports quantification from baseline (<2 ng/mL) to markedly elevated (>1,000 ng/mL) levels in metastatic disease.
The multi-species antibody pair design is optimised for integration into POCT LFA cassettes (5 ng/mL threshold detection) and high-throughput CLIA analyzer cartridges. ISO 13485-compliant batch data supports regulatory submissions to CE IVD (IVDR), NMPA, and TGA. Contact Sekbio to discuss OEM supply agreements and technical integration support.
Technical and commercial questions from IVD R&D engineers and procurement teams.
CEA is a 200 kDa glycoprotein tumour-associated antigen normally present at <5 ng/mL in healthy non-smoking adults. It is the most widely used biomarker for colorectal cancer (CRC) post-surgical monitoring and is also elevated in lung adenocarcinoma, breast, gastric, and pancreatic cancers. ASCO and ESMO guidelines recommend serial CEA monitoring every 3–6 months for 5 years post-CRC resection for early recurrence detection.
Sekbio supplies: S01-CEA-3M (Mouse anti-human CEA mAb, capture), S01-CEA-4S (Recombinant Sheep anti-human CEA mAb, detection, Sheep IgG), and S01-CEA-3 (Recombinant human CEA antigen, CHO expression, 72.9 kDa, pI 5.82) for calibrator preparation. All available from MOQ 1 mg.
Multi-species antibody pairs significantly reduce heterophilic antibody (HAMA) interference that causes false-positive CEA results in same-species sandwich immunoassays. Human anti-mouse antibodies (HAMA) are present in ~3–5% of patients and can cause both false-positive and false-negative results in CLIA platforms. Mouse capture + Sheep detection design minimises this clinically significant analytical error.
Sekbio CEA antibodies are validated for CLIA, ELISA sandwich format, and lateral flow assay (LFA). The recombinant Sheep IgG detection antibody (S01-CEA-4S) can be labelled with colloidal gold, acridinium ester, or HRP for different detection platform requirements.
All CEA antibodies are affinity-purified with purity >90% by SEC-HPLC. The CEA antigen (S01-CEA-3) is >90% pure by SDS-PAGE. Manufactured under ISO 13485 QMS with batch-to-batch CV <10%. Certificate of Analysis provided with every shipment.
Yes. Sekbio can provide CEA detection antibody (S01-CEA-4S) pre-conjugated to colloidal gold (40 nm or 20 nm) or HRP for direct integration into LFA and ELISA kits. Contact info@sekbio.com for conjugation specifications, or visit our Platforms page to learn about our full antibody service capabilities.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply with our team.