TNF-α Monoclonal Antibody for Inflammation & Sepsis CLIA/ELISA IVD Development
TNF-alpha (Tumor Necrosis Factor alpha) is a pleiotropic pro-inflammatory cytokine and a master regulator of the innate immune response. The TNF-alpha monomer is a 17 kDa type II transmembrane protein that is proteolytically cleaved by TACE (TNF-alpha converting enzyme / ADAM17) to yield soluble TNF-alpha. The biologically active form is a non-covalent homotrimer of approximately 51 kDa, which signals through two receptors: TNFR1 (ubiquitous, mediating inflammatory and apoptotic signaling) and TNFR2 (immune cells, mediating proliferative and survival signals). TNF-alpha is predominantly produced by activated macrophages and monocytes in response to bacterial lipopolysaccharide (LPS), viral antigens, and other pathogen-associated molecular patterns (PAMPs).
As the central orchestrator of acute inflammatory responses, TNF-alpha drives fever, acute-phase protein production, neutrophil recruitment, and vascular permeability changes that are essential for host defense but pathological when dysregulated. Elevated serum TNF-alpha (above the normal reference value of <8.1 pg/mL) is a hallmark of: sepsis and septic shock (where markedly elevated TNF-alpha correlates with severity and mortality); rheumatoid arthritis and psoriatic arthritis (where chronic TNF-alpha overproduction drives synovial inflammation and joint destruction); inflammatory bowel disease including Crohn's disease and ulcerative colitis; and severe COVID-19, where a "cytokine storm" — involving TNF-alpha, IL-6, IL-1beta, and interferon-gamma — drives acute respiratory distress syndrome (ARDS) and multiorgan failure.
For IVD immunoassay development, TNF-alpha quantification by CLIA or ELISA sandwich immunoassay is the standard approach. Detection of TNF-alpha in serum and plasma requires antibodies capable of detecting picogram-per-milliliter concentrations with high specificity, given the structural homology between TNF-alpha and TNF-beta (lymphotoxin-alpha). Sekbio supplies TNF-a-W001 (IgG1, capture) and TNF-a-W002 (IgG2a, detection), a dual-isotype matched pair validated for CLIA and ELISA IVD development, covering the clinically relevant range from near-normal (<10 pg/mL) to severely elevated (>1,000 pg/mL in septic shock).
Two anti-TNF-alpha monoclonal antibodies with distinct isotypes for complete CLIA and ELISA sandwich immunoassay development targeting inflammation and sepsis.
| Catalog No. | Product Name | Isotype | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| TNF-a-W001 | Mouse Anti-Human TNF-α Monoclonal Antibody | IgG1 | ≥95% Protein A | Capture — CLIA / ELISA | +2°C to +8°C |
| TNF-a-W002 | Mouse Anti-Human TNF-α Monoclonal Antibody | IgG2a | ≥95% Protein A | Detection — CLIA / ELISA | +2°C to +8°C |
All products supplied in 10 mM PBS, pH 7.4. MOQ 1 mg. OEM quantities (10 mg–gram scale) available. Contact info@sekbio.com for bulk pricing.
Engineered for the ultrasensitive detection required in clinical sepsis diagnosis, inflammatory disease monitoring, and cytokine storm assessment.
Sekbio's TNF-alpha antibody pair comprises two antibodies with distinct isotypes: TNF-a-W001 (IgG1, capture) and TNF-a-W002 (IgG2a, detection). Using antibodies with different isotypes targeting different epitopes on the TNF-alpha trimer enhances sandwich assay sensitivity and minimises cross-reactivity between the capture and detection antibodies. The IgG1/IgG2a dual-isotype configuration is particularly advantageous for detecting the homotrimeric TNF-alpha structure at the picogram-per-milliliter concentrations typical in early sepsis.
TNF-a-W001 and TNF-a-W002 are validated for both CLIA (chemiluminescence immunoassay) and EIA/ELISA (enzyme immunoassay) sandwich formats. This dual-platform validation gives IVD manufacturers flexibility to develop high-throughput CLIA assays for ICU and emergency medicine TNF-alpha testing, as well as ELISA kits for rheumatology and gastroenterology laboratories, pharmaceutical cytokine monitoring studies, and research-grade inflammation profiling — all from a single antibody source.
Both TNF-alpha antibodies are purified by Protein A affinity chromatography to ≥95% purity — a higher purity tier than the standard >90% SEC-HPLC specification. Higher purity directly reduces non-specific binding and background signal in ultrasensitive cytokine assays. This is critical for TNF-alpha quantification in serum, where the target concentration in healthy individuals (<8.1 pg/mL) approaches the lower sensitivity limit of conventional ELISA platforms, making antibody purity a key determinant of assay sensitivity and specificity.
Manufactured under ISO 13485 quality management system with inter-batch CV <10%. Each production lot undergoes appearance inspection, Protein A purification purity verification, and functional bioreactivity QC in sandwich CLIA/ELISA format. Full Certificate of Analysis with lot-specific QC data is provided with every shipment. Consistent inter-lot performance is essential for cytokine panel kits used in multicenter sepsis studies and clinical trials evaluating anti-TNF therapeutic response.
TNF-alpha is one of the most clinically relevant cytokines across multiple disease areas: sepsis/ICU (TNF-alpha elevation predicts severity and guides therapy), rheumatoid arthritis (disease activity monitoring and anti-TNF therapeutic response), IBD (Crohn's disease and ulcerative colitis activity), and severe COVID-19 (cytokine storm triage and prognosis). A single TNF-alpha CLIA/ELISA antibody pair from Sekbio enables IVD developers to address multiple high-value clinical markets with one raw material source.
ISO 13485-compliant manufacturing in Shenzhen, China. MOQ 1 mg for R&D evaluation; gram-scale production supply for OEM kit manufacturing. TNF-alpha can be co-developed with Sekbio's IL-6, IL-10, IL-1beta, and other cytokine antibody pairs for comprehensive inflammation panel kits. Full regulatory documentation for CE, NMPA, and FDA submissions. Visit our Platforms page for cytokine antibody development services, or browse our complete antibody catalog.
TNF-alpha antibody pair validated for sepsis, rheumatoid arthritis, inflammatory bowel disease, and COVID-19 cytokine storm kit development.
Sepsis is the leading cause of death in ICUs worldwide, responsible for approximately 11 million deaths annually (Lancet, 2020). Serum TNF-alpha is markedly elevated in bacterial sepsis and septic shock, particularly in Gram-negative bacteraemia where LPS-driven macrophage activation produces a massive TNF-alpha surge. TNF-alpha levels >100 pg/mL correlate with septic shock severity and 28-day mortality. Quantitative TNF-alpha CLIA assays integrated with PCT and IL-6 in sepsis diagnostic panels provide clinicians with a comprehensive inflammatory picture for ICU triage, antibiotic stewardship decisions, and prognosis assessment. Sekbio's TNF-a-W001/W002 pair supports high-sensitivity sepsis panel CLIA kit development.
TNF-alpha is a central driver of synovial inflammation, pannus formation, and joint destruction in rheumatoid arthritis (RA). Anti-TNF biological therapies (adalimumab, etanercept, infliximab) are first-line bDMARDs for moderate-to-severe RA, making TNF-alpha monitoring clinically relevant for both diagnosis and therapeutic response assessment. Serum TNF-alpha levels correlate with disease activity scores (DAS28) and CRP in active RA. TNF-alpha ELISA and CLIA kits using Sekbio's antibody pair support rheumatology laboratory development of RA disease activity monitoring panels alongside CRP, ESR, anti-CCP, and RF testing, addressing the growing global rheumatology diagnostics market.
In Crohn's disease and ulcerative colitis, elevated mucosal and serum TNF-alpha reflects active intestinal inflammation and correlates with disease activity indices (Harvey-Bradshaw Index, Mayo Score). Anti-TNF biologicals (infliximab, adalimumab, certolizumab) are effective induction and maintenance therapies for moderate-to-severe IBD. Serum TNF-alpha quantification supports disease activity assessment, treatment decision-making, and monitoring of anti-TNF therapeutic drug levels alongside trough concentrations and anti-drug antibody (ADA) testing. ELISA-format TNF-alpha assays using Sekbio's dual-platform antibody pair are well-suited for IBD research and clinical laboratory applications.
Severe COVID-19 is characterized by a dysregulated hyperinflammatory response — "cytokine storm" — involving markedly elevated TNF-alpha, IL-6, IL-1beta, IP-10, and MCP-1. Elevated serum TNF-alpha (>300 pg/mL in severe COVID-19) is associated with ARDS, multiorgan failure, and ICU admission. TNF-alpha monitoring, alongside IL-6 and ferritin, guides clinical decisions on immunomodulatory therapy (corticosteroids, tocilizumab, baricitinib). IVD manufacturers developing COVID-19 severity stratification and cytokine storm monitoring panels can integrate Sekbio's TNF-a-W001/W002 antibody pair with IL-6 and IL-10 antibodies. Contact our team for multiplex cytokine panel support. See the full antibody catalog.
Technical and commercial questions from IVD R&D engineers and procurement teams developing TNF-alpha inflammation CLIA/ELISA assays.
TNF-alpha (Tumor Necrosis Factor alpha) is a 17 kDa pro-inflammatory cytokine (biologically active as a 51 kDa homotrimer) primarily produced by activated macrophages. It is the master regulator of acute inflammation, and is markedly elevated in sepsis/septic shock, rheumatoid arthritis, IBD (Crohn's disease, ulcerative colitis), and severe COVID-19 (cytokine storm). Normal serum TNF-alpha: <8.1 pg/mL. TNF-alpha CLIA/ELISA quantification enables inflammatory status assessment, disease activity monitoring, and anti-TNF therapeutic response evaluation in key clinical and research settings.
Sekbio supplies: TNF-a-W001 (mouse anti-human TNF-alpha mAb, IgG1, for CLIA/ELISA capture) and TNF-a-W002 (mouse anti-human TNF-alpha mAb, IgG2a, for CLIA/ELISA detection). Both are Protein A purified to ≥95% purity, supplied in 10 mM PBS, pH 7.4. Certificate of Analysis provided with every lot. MOQ 1 mg.
TNF-a-W001 and TNF-a-W002 are validated for both CLIA (chemiluminescence immunoassay) and EIA/ELISA (enzyme immunoassay) sandwich formats. Dual-platform validation enables IVD manufacturers to use the same antibody pair for high-throughput CLIA analyzer integration (hospital ICU, rheumatology) and plate-based ELISA kit development (laboratory research, lower-volume clinical testing). For other platforms, contact info@sekbio.com.
Using antibodies with different isotypes (IgG1 for capture, IgG2a for detection) provides two key advantages. First, different isotypes indicate that the antibodies were selected from independent immunisation clones recognising distinct, non-overlapping epitopes on the TNF-alpha homotrimer — a prerequisite for an effective sandwich assay. Second, the different Fc regions of IgG1 and IgG2a ensure that secondary detection reagents (anti-Fc HRP conjugates for ELISA, or CLIA signal amplification systems) can be applied without cross-reactivity between the capture and detection antibodies, improving assay signal-to-noise ratio.
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 10 mM PBS, pH 7.4. Shelf life: 3 years from manufacturing date.
Yes. Sekbio supplies TNF-alpha antibodies at gram scale under ISO 13485 QMS for global OEM cytokine panel CLIA and ELISA kit manufacturers. TNF-a-W001/W002 can be integrated into multi-cytokine panels alongside IL-6, IL-10, IL-1beta, IFN-gamma, and other inflammation markers. Full regulatory documentation for CE marking (EU IVDR), NMPA registration, and FDA 510(k) dossiers available. Contact info@sekbio.com to discuss OEM supply, panel configuration, and regulatory support. Visit our Platforms page for cytokine antibody development services.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply with our team.