C-Peptide Monoclonal Antibody for Diabetes Diagnosis & Beta-Cell Function CLIA IVD Development
C-Peptide (connecting peptide) is a 31-amino acid polypeptide with a molecular weight of approximately 3.0 kDa, generated during the biosynthesis of insulin in pancreatic beta cells. Proinsulin — the precursor molecule — is cleaved by prohormone convertases (PC1/3 and PC2) in the secretory granules to yield insulin (A and B chains) and C-Peptide in equimolar amounts. Because C-Peptide is co-secreted with insulin in a 1:1 molar ratio, its serum concentration provides a direct, quantitative measure of endogenous insulin secretion that is not confounded by exogenous insulin administration.
C-Peptide offers two critical analytical advantages over insulin as a biomarker of beta-cell function. First, its half-life is approximately 30 minutes — roughly six times longer than insulin (~5 minutes) — making it substantially more stable in peripheral blood. Second, C-Peptide undergoes minimal hepatic clearance (unlike insulin, ~50% of which is extracted by the liver on first pass), resulting in peripheral C-Peptide concentrations that more accurately reflect pancreatic secretory output. Normal fasting serum C-Peptide is 0.5–2.0 ng/mL; post-stimulation peak values of 5–10 ng/mL are expected in healthy individuals with intact beta-cell reserve.
In clinical practice, C-Peptide measurement is the preferred method for differentiating type 1 from type 2 diabetes (type 1: low/undetectable; type 2: normal or elevated), assessing residual beta-cell function in established diabetes, diagnosing insulinoma (elevated fasting C-Peptide with hypoglycaemia), and monitoring islet cell or pancreatic transplant function. For IVD immunoassay development, C-Peptide CLIA sandwich immunoassay is the standard clinical platform. Sekbio supplies S01-CP-1M (capture) and S01-CP-2M (detection), a validated matched pair for C-Peptide CLIA IVD development.
Two anti-C-Peptide monoclonal antibodies for complete CLIA sandwich immunoassay development targeting insulin secretion and beta-cell function.
| Catalog No. | Product Name | Isotype | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| S01-CP-1M | Mouse Anti-Human C-Peptide Monoclonal Antibody | IgG1 | >90% SEC-HPLC | Capture — CLIA | +2°C to +8°C |
| S01-CP-2M | Mouse Anti-Human C-Peptide Monoclonal Antibody | IgG1 | >90% SEC-HPLC | Detection — CLIA | +2°C to +8°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.
Engineered for the sensitivity and dynamic range required in clinical diabetes diagnosis, beta-cell function assessment, and insulin secretion monitoring.
Sekbio provides S01-CP-1M (capture) and S01-CP-2M (detection) as a validated matched pair targeting distinct, non-overlapping epitopes on the 31-amino acid C-Peptide molecule. Despite C-Peptide's small size (3.0 kDa), the pair is optimized for high-sensitivity CLIA sandwich immunoassay capable of discriminating low C-Peptide levels in type 1 diabetes (approaching zero) from normal fasting values (0.5–2.0 ng/mL) and post-stimulation peaks (>5 ng/mL).
Both S01-CP-1M and S01-CP-2M are validated for CLIA (chemiluminescence immunoassay) sandwich format — the dominant platform for C-Peptide quantification in clinical diabetes laboratories. The validated pair supports integration into automated CLIA analyzer workflows used in hospital endocrinology departments, diabetes specialty clinics, and reference laboratories for C-Peptide stimulation testing, fasting C-Peptide measurement, and post-transplant monitoring.
Manufactured under ISO 13485 quality management system with inter-batch CV <10%. Each production lot undergoes appearance, purity by SEC-HPLC, and bioreactivity QC in the validated CLIA format. Full Certificate of Analysis with every shipment. Consistent inter-lot performance is critical for serial C-Peptide monitoring in longitudinal diabetes studies, islet transplant programs, and therapeutic clinical trials assessing beta-cell preservation.
Purity >90% by SEC-HPLC with low aggregation is critical for C-Peptide CLIA assays, which must detect very low concentrations (<0.1 ng/mL) in type 1 diabetes patients with complete beta-cell failure. High-purity antibodies reduce non-specific binding and background noise, enabling the low assay detection limit required to discriminate between undetectable C-Peptide (absolute insulin deficiency), borderline residual secretion, and normal fasting levels in mixed patient populations.
C-Peptide is a core component of comprehensive diabetes diagnosis and management CLIA panels alongside insulin, HbA1c, and glucose. Sekbio's C-Peptide antibody pair can be co-developed with complementary endocrinology markers including insulin and glucagon on a single CLIA platform. Sourcing the complete diabetes biomarker antibody panel from a single ISO 13485-certified supplier simplifies regulatory documentation for multi-analyte CLIA system development for European, US, and Asian markets.
ISO 13485-compliant manufacturing in Shenzhen, China. MOQ 1 mg for R&D evaluation; gram-scale production supply for OEM CLIA kit manufacturing. Full regulatory documentation available for CE marking (EU IVDR), NMPA, and FDA submissions. C-Peptide CLIA kits are in growing demand globally, driven by rising diabetes prevalence (537 million adults, IDF 2021) and increasing adoption of precision diabetes management protocols. Visit our Platforms page.
C-Peptide antibody pair validated for diabetes diagnosis, beta-cell function assessment, insulinoma diagnosis, and islet transplant monitoring kit development.
Accurate differentiation of type 1 from type 2 diabetes has significant clinical implications for treatment decisions, particularly regarding the timing of insulin initiation and the avoidance of inappropriate oral hypoglycaemic agents in type 1 patients. C-Peptide is the recommended biomarker for this differentiation: undetectable or very low fasting C-Peptide (<0.2 ng/mL) combined with positive diabetes autoantibodies (GAD65, IA-2, ZnT8) indicates type 1 diabetes. Normal or elevated C-Peptide with clinical type 2 features indicates type 2 diabetes. Sekbio's S01-CP-1M/2M CLIA pair supports accurate differentiation assay development for this high-value clinical application.
Monitoring residual beta-cell function is critical in established type 1 diabetes, latent autoimmune diabetes in adults (LADA), and in clinical trials evaluating beta-cell preservation therapies (immunotherapy, stem cell therapy, islet transplantation). C-Peptide stimulation testing — using glucagon or mixed meal stimulus — quantifies the remaining secretory capacity of beta cells. Even modest residual C-Peptide secretion (>0.2 ng/mL post-stimulation) is associated with reduced HbA1c, fewer hypoglycaemic episodes, and lower risk of microvascular complications. High-sensitivity CLIA C-Peptide assays using Sekbio's antibody pair support longitudinal beta-cell monitoring.
Insulinoma — a rare insulin-secreting pancreatic neuroendocrine tumor — is characterised by endogenous hyperinsulinaemia causing fasting hypoglycaemia. The diagnostic criterion (Whipple's triad + elevated fasting C-Peptide) requires accurate C-Peptide quantification during a supervised 72-hour fast or mixed meal test. Elevated C-Peptide (>0.6 ng/mL) concurrent with serum glucose <55 mg/dL confirms endogenous hyperinsulinaemia, distinguishing insulinoma from factitious hypoglycaemia caused by exogenous insulin injection (which suppresses C-Peptide). Sekbio's CLIA antibody pair enables precise C-Peptide measurement for insulinoma workup kits.
C-Peptide is a standard component of hospital endocrinology and diabetes CLIA panels. IVD manufacturers developing diabetes diagnostic systems can integrate Sekbio's S01-CP-1M/S01-CP-2M antibody pair for C-Peptide quantification alongside insulin, HbA1c, and glucose assays. ISO 13485-certified batch data, Certificate of Analysis, and regulatory documentation are available for CE, NMPA, and FDA 510(k) dossiers. The global diabetes diagnostics market was valued at over $25 billion in 2023 and continues to grow. Contact our team for OEM supply agreements. See our full antibody catalog.
Technical and commercial questions from IVD R&D engineers and procurement teams developing C-Peptide diabetes CLIA assays.
C-Peptide is a 31-amino acid, 3.0 kDa connecting peptide co-secreted with insulin from pancreatic beta cells in equimolar amounts. Its longer half-life (~30 min vs ~5 min for insulin) and minimal hepatic clearance make serum C-Peptide a more stable and reliable indicator of endogenous insulin secretion than insulin itself. Normal fasting C-Peptide: 0.5–2.0 ng/mL. C-Peptide is the guideline-recommended marker for: type 1 vs type 2 diabetes differentiation, residual beta-cell function assessment, insulinoma diagnosis, and islet transplant monitoring.
Sekbio supplies: S01-CP-1M (mouse anti-human C-Peptide mAb, IgG1, for CLIA capture) and S01-CP-2M (mouse anti-human C-Peptide mAb, IgG1, for CLIA detection). Both are affinity-purified, purity >90% by SEC-HPLC, supplied in 20 mM PB, 150 mM NaCl, pH 7.4. Certificate of Analysis provided with every lot. MOQ 1 mg.
S01-CP-1M and S01-CP-2M are validated for CLIA (chemiluminescence immunoassay) sandwich format — the preferred platform for C-Peptide quantification in clinical laboratories. The pair supports integration into automated CLIA analyzer workflows for high-throughput diabetes diagnosis and beta-cell function testing. For other platforms (ELISA), contact info@sekbio.com to discuss technical feasibility.
Both antibodies are purified with >90% purity by SEC-HPLC. Manufactured under ISO 13485 QMS with inter-batch CV <10%. Each production lot undergoes appearance inspection, SEC-HPLC purity analysis, and functional bioreactivity QC in the CLIA sandwich format. A Certificate of Analysis with lot-specific QC data is provided with every shipment. Consistent lot-to-lot performance is critical for longitudinal C-Peptide monitoring in diabetes clinical studies and islet transplant programs.
MOQ is 1 mg for R&D evaluation; OEM quantities from 10 mg to gram scale available. Storage: +2°C to +8°C short-term (≤1 month); −20°C long-term. Avoid repeated freeze/thaw cycles. All supplied in 20 mM PB, 150 mM NaCl, pH 7.4. Shelf life: 3 years from manufacturing date.
Yes. Sekbio supplies C-Peptide antibodies at gram scale under ISO 13485 QMS for global OEM CLIA kit manufacturers. Full regulatory documentation including Certificate of Analysis, manufacturing records, and material safety data is available for CE marking (EU IVDR), NMPA registration, and FDA 510(k) submissions. C-Peptide CLIA kits are in growing demand across Europe, North America, China, and India. Contact info@sekbio.com for OEM supply agreements. Visit our Platforms page for antibody development services.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply with our team.