Pancreatic Cancer Monoclonal Antibody for CLIA & ELISA Immunoassay Development
CA19-9 (Carbohydrate Antigen 19-9), also known as sialyl-Lewis a (SLea), is a carbohydrate antigen expressed on the surface of pancreatic, hepatobiliary, and gastrointestinal epithelial cells. CA19-9 is the primary serum biomarker for pancreatic ductal adenocarcinoma (PDAC) — the fourth leading cause of cancer-related mortality globally, with sensitivity of 70–80% and specificity of 85–90% at the standard 37 U/mL cut-off.
For IVD sandwich immunoassay development, CA19-9 quantification presents a unique challenge: the sialyl-Lewis a antigen is a carbohydrate structure, not a protein — requiring antibodies that recognise the glycan epitope with high specificity. Sekbio supplies three CA19-9 antibodies supporting two validated reference-equivalent pairs: Roche-equivalent (S01-A111-1M coated + S01-A111-1H conjugated) and CanAg-equivalent (S01-A111-4M coated + S01-A111-4M conjugated).
CA19-9 is also used in cholangiocarcinoma, gastric cancer, and colorectal cancer staging and monitoring. An important clinical limitation: approximately 5–10% of the population are Lewis antigen-negative (Le[a-b-] blood group) and cannot produce CA19-9 — yielding a zero result regardless of cancer burden.
Three CA19-9 antibodies supporting two validated reference-equivalent sandwich pairs for Roche and CanAg platform traceability.
| Catalog No. | Product Name | Species / Format | Reference Clone | Recommended Role | Purity | Storage |
|---|---|---|---|---|---|---|
| S01-A111-1M | Mouse Anti-CA19-9 mAb | Mouse mAb | Similar to 1116-NS-19-9 | Capture (Roche pair) | >90% SEC-HPLC | +2°C to +8°C |
| S01-A111-1H | Humanized Anti-CA19-9 mAb | Humanized mAb | Similar to 1116-NS-19-9 | Detection (Roche pair) | >90% SEC-HPLC | +2°C to +8°C |
| S01-A111-4M | Mouse Anti-CA19-9 mAb | Mouse mAb | Similar to C192 | Capture + Detection (CanAg pair) | >90% SEC-HPLC | +2°C to +8°C |
Roche-equivalent pair: S01-A111-1M (coated/capture) + S01-A111-1H (conjugated/detection). CanAg-equivalent pair: S01-A111-4M (coated) + S01-A111-4M (conjugated). MOQ 1 mg. Contact info@sekbio.com for pair selection and bulk pricing.
Two validated reference-equivalent CA19-9 pairs enabling Roche and CanAg platform calibration traceability from a single ISO 13485 supplier.
S01-A111-1M (capture) + S01-A111-1H (detection) mirrors the 1116-NS-19-9 epitope specificity used in Roche Elecsys CA19-9 and cobas CA19-9 assays. Clinical correlation data against Roche Elecsys CA19-9 confirms traceability, enabling CE-marked and NMPA-registered IVD assays that report CA19-9 results consistent with the Roche reference method.
S01-A111-4M (coated) + S01-A111-4M (conjugated) replicates the C192 clone bridging sandwich format used in the CanAg CA19-9 EIA — the reference method for many European laboratory CA19-9 calibration hierarchies. Validated against CanAg CA19-9 EIA for laboratories requiring CanAg calibration traceability.
The humanized S01-A111-1H targets the identical sialyl-Lewis a epitope as S01-A111-1M but with human IgG framework residues, reducing HAMA interference in CLIA assays. For the Roche-equivalent pair, using the humanized detection antibody is the recommended configuration for HAMA-mitigated clinical immunoassay performance.
Sekbio CA19-9 antibody pairs are validated to quantify across the 2–1,000 U/mL analytical range required for clinical CA19-9 assays, covering normal (<37 U/mL), borderline (37–100 U/mL), and high-concentration malignant (100–1,000 U/mL) ranges with <10% CV at the 37 U/mL clinical decision point.
All CA19-9 antibodies are affinity-purified with purity >90% by SEC-HPLC and monomer content >95%. CA19-9 is a carbohydrate antigen — antibody purity and aggregation state directly impact assay precision. High-purity preparations minimise lot-to-lot variability at the critical 37 U/mL diagnostic cut-off.
Manufactured under ISO 13485 QMS with inter-batch CV <10% and Certificate of Analysis for every lot. Gram-scale OEM supply available for production. Custom antibody formats — biotinylated, enzyme-conjugated, or colloidal gold-labelled — available upon request for direct kit integration.
CA19-9 >37 U/mL combined with imaging supports pancreatic cancer diagnosis with 70–80% sensitivity. Very high levels (>1,000 U/mL) correlate with advanced or metastatic PDAC and predict poor prognosis. CLIA assays using Sekbio's Roche-equivalent CA19-9 antibody pair enable clinical laboratory-grade quantification for oncology diagnostic workflows globally.
Serial CA19-9 measurements during gemcitabine/nab-paclitaxel or FOLFIRINOX chemotherapy monitor PDAC treatment response. A >50% CA19-9 decline from baseline correlates with tumour regression and improved survival. Post-treatment rising CA19-9 is the earliest indicator of locoregional or distant recurrence, triggering re-staging imaging.
CA19-9 is elevated in 60–70% of cholangiocarcinoma cases and supports differential diagnosis of malignant biliary strictures. Combined with CA125, CA19-9 >100 U/mL distinguishes cholangiocarcinoma from primary sclerosing cholangitis (PSC) with improved specificity. Sekbio's CA19-9 antibody pair enables the hepatobiliary oncology CLIA panels for global IVD manufacturers.
IVD manufacturers developing CE-marked or NMPA-registered CA19-9 assays can choose Roche-traceable (S01-A111-1M + S01-A111-1H) or CanAg-traceable (S01-A111-4M + S01-A111-4M) pairs with full ISO 13485 documentation. Both pairs support CE IVDR, NMPA registration, and FDA 510(k) submissions with available clinical correlation data.
CA19-9 (sialyl-Lewis a, SLea) is a carbohydrate antigen elevated in pancreatic ductal adenocarcinoma (PDAC). At the 37 U/mL cut-off, CA19-9 has 70–80% sensitivity and 85–90% specificity for PDAC. It is also elevated in cholangiocarcinoma, gastric, and colorectal cancers. Note: 5–10% of the population (Le[a-b-] blood type) cannot produce CA19-9.
Sekbio supplies: S01-A111-1M (mouse, similar to 1116-NS-19-9), S01-A111-1H (humanized, same epitope as 1M), S01-A111-4M (mouse, similar to C192). Roche-equivalent pair: S01-A111-1M (capture) + S01-A111-1H (detection). CanAg-equivalent pair: S01-A111-4M (capture) + S01-A111-4M (detection).
Choose the Roche-equivalent pair (S01-A111-1M + S01-A111-1H) if your target market requires Roche Elecsys CA19-9 calibration traceability (common in hospital laboratories). Choose the CanAg-equivalent pair (S01-A111-4M + S01-A111-4M) if CanAg EIA traceability is required. Both pairs are validated; selection depends on your clinical correlation reference method.
S01-A111-1H targets the identical sialyl-Lewis a epitope as S01-A111-1M but with human IgG framework residues. Using humanized detection reduces HAMA interference — a known source of false-positive CA19-9 results in CLIA assays. The Roche-equivalent pair (1M capture + 1H humanized detection) is the preferred HAMA-mitigated configuration for clinical CLIA platforms.
MOQ is 1 mg for R&D evaluation. OEM production quantities from 10 mg to gram scale are available. All CA19-9 mAbs stable at +2°C to +8°C short-term; −20°C long-term. Avoid repeated freeze/thaw cycles. Shelf life 3 years. Certificate of Analysis with SEC-HPLC purity and functional binding data provided.
Yes. Clinical comparison data against Roche Elecsys CA19-9 and CanAg CA19-9 EIA are available upon request for the respective recommended pairs. These reports support CE IVDR and NMPA regulatory submissions. Contact info@sekbio.com for the full technical datasheet or visit our Oncology Markers page.
Request the full technical datasheet, pair selection guidance, or discuss OEM supply with our team.