Neuron-Specific Enolase Monoclonal Antibody for SCLC & Neuroendocrine Tumor IVD Development
Neuron-Specific Enolase (NSE, also known as γ-enolase or enolase 2) is the γγ homodimeric isoform of the glycolytic enzyme 2-phospho-D-glycerate hydrolase. With a subunit molecular weight of ~49 kDa, NSE is expressed at high concentrations in neurons, neuroendocrine cells, and their tumour-derived counterparts. In healthy adults, serum NSE is typically below 12–17 ng/mL depending on the assay platform.
For IVD immunoassay development, NSE is the most established serum biomarker for small cell lung cancer (SCLC) — a highly aggressive neuroendocrine malignancy accounting for 13–15% of all lung cancers. NSE is recommended by ESMO and NCCN guidelines as a complementary biomarker to imaging and biopsy for SCLC staging, treatment monitoring, and relapse detection. Serum NSE >25 ng/mL in a patient with a pulmonary mass is strongly suggestive of SCLC; levels >100 ng/mL indicate extensive-stage disease.
Beyond SCLC, NSE is elevated in neuroblastoma (a leading paediatric solid tumour), Merkel cell carcinoma, carcinoid tumours, phaeochromocytoma, and other neuroendocrine neoplasms. NSE immunoassays are developed using a sandwich format with matched monoclonal antibodies recognising distinct, non-overlapping epitopes on the NSE γγ dimer. Sekbio supplies a matched antibody/antigen system for CLIA, ELISA, CMIA, and POCT development.
Matched monoclonal antibody and recombinant NSE antigen for a complete immunoassay development system.
| Catalog No. | Product Name | Species / Format | MW / Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| NSE-W31M | Mouse Anti-NSE Monoclonal Antibody | Mouse | >90% SEC-HPLC | Capture / Detection — CLIA, ELISA, POCT | +2°C to +8°C |
| NSE-W131 | Recombinant Human NSE Protein (Antigen) | E. coli (Full length) | 49.1 kDa (monomer), pI 5.41 | Calibrator / Positive Control | −20°C ±2°C |
All antibody products supplied in 20 mM Tris/PBS buffer. MOQ 1 mg. OEM quantities (10 mg–gram scale) available. Contact info@sekbio.com for bulk pricing and lot availability.
Engineered for the sensitivity and batch consistency required in SCLC clinical management and neuroendocrine tumour monitoring.
NSE-W31M is pre-screened for high-affinity binding to the γγ NSE homodimer. Bioreactivity data confirm a linear detection range of 0.16–500 ng/mL with signal-to-noise >3.5 at the 0.16 ng/mL lower limit, covering the full clinical range from normal to high-burden SCLC.
Affinity-purified from cell culture supernatants with SEC-HPLC purity >90%. Low aggregation minimises non-specific binding, improving signal-to-noise ratios in both CLIA analyzer formats and plate-based ELISA applications.
Validated for CLIA, ELISA, CMIA, and Rapid Test/POCT formats. The antibody pair supports quantitative analyzer-based CLIA platforms, high-throughput ELISA kits, and point-of-care lateral flow strip development — providing flexibility across IVD product lines.
NSE-W131 recombinant full-length human NSE protein (49.1 kDa monomer, pI 5.41, E. coli expression) is available for calibrator preparation, assay validation, and positive control manufacture. Characterised by SDS-PAGE and bioreactivity testing with the matched antibody.
Manufactured under ISO 13485 quality management system with inter-batch CV <10%. Each lot undergoes appearance, purity, molecular weight, and bioreactivity QC before release. Full Certificate of Analysis provided with every shipment.
ISO 13485-compliant manufacturing in Shenzhen, China. MOQ 1 mg for R&D evaluation; gram-scale production supply for OEM manufacturing. Supports CE, NMPA, and FDA regulatory submissions with batch documentation and COA.
NSE antibody pair validated for oncology diagnostics, SCLC staging, and neuroendocrine tumour monitoring assay development.
NSE is the primary serum biomarker for SCLC, recommended by ESMO and NCCN guidelines as a complementary diagnostic tool in conjunction with imaging and histopathology. Serum NSE >25 ng/mL in a patient with a pulmonary mass is strongly suggestive of SCLC. NSE levels correlate with tumour burden: limited-stage SCLC typically shows levels of 20–50 ng/mL, while extensive-stage disease may exceed 100 ng/mL. Sensitive CLIA assays using Sekbio NSE antibodies support early detection and staging.
Serial NSE quantification during and after chemotherapy (etoposide/platinum regimens) provides early indication of treatment response or progression. A post-treatment NSE decline >50% from baseline within 2 cycles predicts improved progression-free survival. Rising NSE during surveillance (above 25% increase from nadir) may indicate relapse weeks before radiological progression, enabling earlier therapeutic intervention.
NSE is a validated biomarker for neuroblastoma — the most common extracranial solid tumour in children. Serum NSE >100 ng/mL at diagnosis correlates with high-risk disease and poor prognosis by INRG classification. NSE monitoring during induction chemotherapy and ASCT guides treatment intensity decisions. Quantitative CLIA assays using Sekbio NSE antibody pair support paediatric oncology IVD kit development.
NSE is part of neuroendocrine tumour biomarker panels alongside CgA (chromogranin A) and specific hormones. Elevated NSE is seen in Merkel cell carcinoma, phaeochromocytoma, medullary thyroid carcinoma, and carcinoid tumours. OEM CLIA analyzer manufacturers and ELISA kit developers can integrate Sekbio NSE antibody pair with ISO 13485 batch documentation for CE, FDA, and NMPA regulatory submissions. Visit our Products page for related oncology biomarker raw materials.
Technical and commercial questions from IVD R&D engineers and procurement teams.
Neuron-Specific Enolase (NSE) is the γγ homodimeric isoform of enolase, expressed predominantly in neurons and neuroendocrine cells. In serum, NSE is elevated in small cell lung cancer (SCLC), neuroblastoma, and other neuroendocrine tumours. It is the recommended SCLC biomarker by ESMO and NCCN guidelines, with a clinical cutoff typically >16–25 ng/mL depending on platform. NSE is used for SCLC staging, treatment monitoring, and relapse detection.
Sekbio supplies NSE-W31M (mouse anti-NSE monoclonal antibody for CLIA/ELISA capture and detection) and NSE-W131 (recombinant full-length human NSE protein, 49.1 kDa monomer, pI 5.41, E. coli expression) for calibrator and positive control preparation. All products available from MOQ 1 mg with 3-year shelf life.
NSE antibodies are validated for CLIA, ELISA, CMIA (chemiluminescent microparticle immunoassay), and Rapid Test/POCT sandwich formats. Bioreactivity data confirm detection range 0.16–500 ng/mL, covering the full range from normal to high-burden SCLC. Signal-to-noise >3.5 at the 0.16 ng/mL lower limit.
NSE-W31M antibody: purity >90% by SEC-HPLC, affinity-purified from cell culture supernatants. Manufactured under ISO 13485 QMS with inter-batch CV <10%. Each lot undergoes appearance, purity, molecular weight, and bioreactivity QC before release. Certificate of Analysis provided with each shipment.
MOQ is 1 mg for R&D evaluation; OEM production quantities from 10 mg to gram scale are available. NSE-W31M antibody: +2°C to +8°C short-term (≤1 month); −20°C long-term. NSE-W131 antigen: −20°C ±2°C. Avoid repeated freeze/thaw cycles. Shelf life is 3 years from manufacturing date.
Yes. NSE-W31M is validated for Rapid Test/POCT formats and can be used for colloidal gold or fluorescent microsphere conjugation in lateral flow assay (LFA) and fluorescence immunoassay (FIA) development. Custom NSE antibody engineering for specific conjugation chemistries or alternative formats is available through Sekbio's antibody development platform in 8–12 weeks. Contact info@sekbio.com or visit our Platforms page.
Request the full technical datasheet, antibody specifications, or discuss OEM supply with our team.