Antibody Raw Material · OEM Ready

CA50 Antibody Pair

Pancreatic & GI Cancer Monoclonal Antibody for CLIA & ELISA Immunoassay Development

CLIA ELISA Pancreatic Cancer CanAg C50 Equivalent Humanized Available
2
Antibody SKUs (Mouse + Humanized)
2
Glycan Epitopes Recognised
<10%
Batch-to-Batch CV
1 mg
Minimum Order Quantity

What is CA50? — A Definition for IVD Developers

CA50 (Carbohydrate Antigen 50) is a sialylated carbohydrate tumor antigen recognised by antibodies that detect two structurally related glycan structures: sialylated Lewis a (SLea, the CA19-9 antigen) and sialylated lacto-N-tetraose. Because CA50 antibodies bind both glycan structures, CA50 has a distinct clinical advantage over CA19-9: it can detect some signal in Lewis antigen-negative patients (Le[a-b-] blood type, ~5–10% of the population) who give a zero CA19-9 result regardless of tumour burden.

CA50 is used in pancreatic, cholangiocarcinoma, colorectal, and gastric cancer monitoring — predominantly in Scandinavian and European laboratory medicine where the CanAg CA50 C50 EIA was widely adopted as the original reference method. Sekbio supplies two CA50 antibodies in the S01-A110 series: S01-A110-1M (mouse mAb, dual-glycan epitope) and S01-A110-1H (humanized mAb, same epitope), both validated against the CanAg CA50 C50 reference antibody system.

CA50 is most commonly used alongside CA19-9 and CEA in GI cancer monitoring panels, where the CA50/CA19-9 ratio provides additional diagnostic information. Normal CA50 reference: <17 U/mL.

Pancreatic / GI Cancer Dual-Glycan Epitope ISO 13485 Manufacturer CanAg C50 Validated

Antibody Specifications (S01-A110-1M)

Product NameMouse Anti-CA50 mAb
Catalog No.S01-A110-1M
EpitopeSialylated Lewis a + Sialylated lacto-N-tetraose
Host SpeciesMouse
Antibody TypeMonoclonal (IgG)
Purity>90% (SEC-HPLC)
FormatPurified, Liquid
Storage+2°C to +8°C (short); −20°C (long)
Shelf Life3 years
Validated vsCanAg CA50 C50

CA50 Antibody Pair — All SKUs

Mouse and humanized CA50 antibodies with identical dual-glycan epitope specificity for HAMA-sensitive CLIA platform development.

Catalog No.Product NameSpecies / FormatEpitope SpecificityValidated vs ReferencePurityStorage
S01-A110-1MMouse Anti-CA50 mAbMouse mAbSialylated Lewis a + Sialylated lacto-N-tetraoseCanAg CA50 C50>90% SEC-HPLC+2°C to +8°C
S01-A110-1HHumanized Anti-CA50 mAbHumanized mAbSialylated Lewis a + Sialylated lacto-N-tetraoseCanAg CA50 C50>90% SEC-HPLC+2°C to +8°C

Both antibodies target identical dual-glycan CA50 epitopes; S01-A110-1H provides the humanized alternative for HAMA-mitigated CLIA assay development. MOQ 1 mg. OEM quantities from 10 mg to gram scale available. Contact info@sekbio.com for sandwich pair optimisation guidance (capture/detection configuration).

Performance Advantages for IVD Assay Development

CanAg C50-validated CA50 antibody pair with humanized variant — enabling Lewis antigen-inclusive GI cancer panel development.

Dual-Glycan Epitope — SLea + Lacto-N-Tetraose

S01-A110-1M and S01-A110-1H recognise both the sialylated Lewis a (SLea, the CA19-9 antigen) and the sialylated lacto-N-tetraose structure. This dual-glycan specificity enables CA50 detection in Lewis antigen-negative patients (Le[a-b-]) who would otherwise give a false-negative CA19-9 result — covering 5–10% of the population that CA19-9-only panels miss.

CanAg CA50 C50 Reference Validated

Both S01-A110-1M and S01-A110-1H are validated against the CanAg CA50 C50 reference antibody system — the established standard for CA50 immunoassay in Scandinavian and European IVD laboratory medicine. Correlation data against CanAg CA50 C50 EIA supports CE IVDR and regulatory submissions for European market entry.

Humanized Variant for HAMA Reduction

S01-A110-1H (humanized) shares identical CA50 dual-glycan binding with S01-A110-1M (mouse) but with human IgG framework residues. For CLIA platforms serving populations with elevated HAMA (autoimmune patients, biologic-treated patients), substituting the humanized S01-A110-1H as the detection antibody prevents HAMA-mediated false-positive CA50 results without altering epitope specificity.

Complementary to CA19-9 in GI Panels

CA50 and CA19-9 are complementary — not interchangeable — in GI cancer panels. Combining CA50 (S01-A110 pair) with CA19-9 (S01-A111 pair) and CEA in a multi-marker panel improves population-level sensitivity by covering Lewis-negative patients and providing a CA50/CA19-9 ratio metric. Sekbio supplies all three antibody pairs for integrated GI cancer panel development.

Clinical Range 0.5–200 U/mL Validated

The S01-A110-1M pair is validated across the 0.5–200 U/mL range required for clinical CA50 assays using CanAg C50 calibration, covering the normal reference (<17 U/mL), borderline zone, and high-concentration malignant values. Extended range measurement (>200 U/mL) is supported via appropriate sample dilution.

ISO 13485 Batch Consistency

Both CA50 antibodies manufactured under ISO 13485 QMS with inter-batch CV <10% and full Certificate of Analysis for every lot. Gram-scale OEM supply available. Custom conjugated formats (biotinylated, enzyme-labelled) available upon request for direct integration into CLIA or ELISA kit manufacture without additional conjugation steps.

CA50 Antibody Applications in IVD Development

Pancreatic Cancer Panel — Including Lewis-Negative Patients

CA50 complements CA19-9 in pancreatic cancer panels by covering Lewis antigen-negative patients who give a false-negative CA19-9 result. In a combined CA50 + CA19-9 panel developed using Sekbio's S01-A110 and S01-A111 antibody pairs, the false-negative rate from Lewis-negative status is substantially reduced, improving population-level sensitivity for PDAC screening in high-risk groups.

Cholangiocarcinoma & Hepatobiliary Cancer Monitoring

CA50 is elevated in 60–70% of cholangiocarcinoma (CCA) cases, comparable to CA19-9 sensitivity. In primary sclerosing cholangitis (PSC) patients — who have elevated baseline CA19-9 from biliary inflammation — the CA50/CA19-9 ratio provides additional specificity for malignant transformation. CA50 CLIA assays using Sekbio's antibody pair support hepatobiliary oncology panel development for European markets.

Colorectal Cancer Monitoring

CA50 is elevated in 40–50% of colorectal cancer cases (similar to CA19-9), with superiority in Lewis-negative patients. The CA50 + CEA combination for colorectal cancer monitoring covers a broader patient population than CA19-9 + CEA alone, particularly relevant for Scandinavian markets where CA50 has historically been part of the standard CRC monitoring panel.

OEM CLIA Analyzer & ELISA Kit Development

IVD manufacturers entering European markets with CA50 assays can use Sekbio's S01-A110-1M + S01-A110-1H pair with CanAg C50-traceable validation documentation and ISO 13485-compliant batch records. The availability of both mouse (S01-A110-1M) and humanized (S01-A110-1H) antibodies provides flexibility for HAMA interference management in CE IVDR submissions.

Frequently Asked Questions — CA50 Antibody Pair

What is CA50 and how does it differ from CA19-9?

CA50 recognises both the sialylated Lewis a (SLea, the CA19-9 antigen) and sialylated lacto-N-tetraose glycan structures. This dual-glycan specificity allows CA50 to detect some signal in Lewis antigen-negative patients (Le[a-b-], ~5–10% of the population) who give a zero CA19-9 result. CA50 is used in pancreatic, biliary, colorectal, and gastric cancer monitoring, predominantly in European laboratory medicine.

What catalog numbers are available in Sekbio's CA50 antibody pair?

Sekbio supplies: S01-A110-1M (Mouse mAb, sialylated Lewis a + sialylated lacto-N-tetraose epitope, validated vs CanAg CA50 C50) and S01-A110-1H (Humanized mAb, same dual-glycan epitope, reduced HAMA interference). Both antibodies available from MOQ 1 mg.

How is the Sekbio CA50 antibody pair validated?

Both S01-A110-1M and S01-A110-1H are validated against the CanAg CA50 C50 reference antibody system — the European standard for CA50 immunoassay. Correlation data between Sekbio CA50 pair performance and CanAg CA50 C50 EIA are available upon request for CE IVDR and NMPA regulatory submissions.

Why use CA50 alongside CA19-9 in a GI cancer panel?

CA50 and CA19-9 are complementary, not interchangeable. CA19-9 has slightly higher sensitivity for pancreatic cancer in Lewis-positive patients; CA50 provides coverage for Lewis-negative patients (5–10% of the population) who give a false-negative CA19-9. Combined CA50 + CA19-9 panels improve population-level sensitivity. Sekbio supplies matched antibody pairs for both markers (S01-A110 for CA50, S01-A111 for CA19-9).

When should I use the humanized S01-A110-1H versus mouse S01-A110-1M?

Use S01-A110-1H (humanized) as the detection antibody in CLIA assays for HAMA-sensitive patient populations. HAMA from biologic treatments or autoimmune conditions can cause false-positive CA50 results in mouse mAb-based CLIA assays. The humanized S01-A110-1H eliminates murine framework HAMA binding while retaining identical dual-glycan CA50 specificity.

What is the minimum order quantity and storage condition?

MOQ is 1 mg for R&D evaluation. OEM quantities from 10 mg to gram scale available. Both antibodies stable at +2°C to +8°C short-term; −20°C long-term. Avoid repeated freeze/thaw cycles. Shelf life 3 years. Contact info@sekbio.com for sandwich pair configuration guidance or visit our Oncology Markers page.

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Request the full technical datasheet, sandwich pair configuration guidance, or discuss OEM supply with our team.

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