Early AMI Monoclonal Antibody for LFA Fluorescence & CLIA Immunoassay Development
Myoglobin is a 17.8 kDa oxygen-binding heme protein present in both cardiac and skeletal muscle cells. Following acute myocardial infarction (AMI), myoglobin is released into the bloodstream within 1–3 hours of ischemic onset — significantly earlier than cardiac Troponin I (cTnI, 4–6 hours) or CK-MB (3–4 hours). This rapid release kinetic makes myoglobin the earliest detectable serum marker of myocardial necrosis.
For IVD immunoassay development, myoglobin is incorporated into acute cardiac panel rapid tests (alongside cTnI and CK-MB) where it serves as the early-negative rule-out component in the first critical 2–4 hours of chest pain presentation. Sekbio supplies a matched mouse monoclonal antibody pair — GSA501 (capture) and GSA503 (detection) — with the recombinant myoglobin antigen TSP006 for calibrator and control preparation.
The antibody pair has been validated in lateral flow assay fluorescence immunoassay (LFA-FIA) and CLIA formats with performance benchmarked against the Roche Elecsys Myoglobin ECLIA assay. Normal reference range is 28–72 ng/mL in adults; values above 100 ng/mL are considered elevated in the AMI context.
Capture antibody, detection antibody, and recombinant antigen for a complete myoglobin immunoassay system.
| Catalog No. | Product Name | Species / Format | Role in Assay | Purity | Platform | Storage |
|---|---|---|---|---|---|---|
| GSA501 | Mouse Anti-Myoglobin mAb | Mouse | Capture Antibody | >90% SEC-HPLC | LFA-FIA / CLIA | +2°C to +8°C |
| GSA503 | Mouse Anti-Myoglobin mAb | Mouse | Detection Antibody | >90% SEC-HPLC | LFA-FIA / CLIA | +2°C to +8°C |
| TSP006 | Recombinant Human Myoglobin Antigen | Recombinant | Calibrator / Control | >80% SDS-PAGE | All formats | −20°C ±2°C |
Recommended pair: GSA501 (capture) + GSA503 (detection). All products in PBS, pH 7.4. MOQ 1 mg. OEM quantities (10 mg–gram scale) available. Contact info@sekbio.com for bulk pricing.
Engineered for the rapid detection sensitivity required in emergency AMI rule-out protocols.
Myoglobin rises within 1–3 hours of AMI onset and peaks at 6–9 hours, providing the earliest positive signal in the acute chest pain assessment window. The GSA501 + GSA503 pair achieves the sensitivity required for reliable quantification at near-baseline levels (25–50 ng/mL).
Pre-validated for lateral flow assay fluorescence immunoassay (LFA-FIA) format, the dominant point-of-care platform for acute cardiac panels. The antibody pair is optimised for colloidal gold and quantum dot conjugation, supporting both qualitative and quantitative POCT strip development.
Clinical performance of the GSA501 + GSA503 pair has been validated against the Roche Elecsys Myoglobin ECLIA assay — the global reference standard. Correlation data is available to support CE and NMPA regulatory submissions for OEM kit manufacturers.
Myoglobin (GSA501/GSA503) is designed to integrate into Sekbio's complete acute cardiac panel alongside cTnI and CK-MB antibody pairs, enabling simultaneous 3-marker multiplex LFA strip or CLIA panel development from a single supplier without cross-reactivity concerns.
TSP006 recombinant human myoglobin antigen enables in-house calibrator preparation, assay validation, and positive control manufacture — eliminating dependence on native myoglobin from human pooled sera and ensuring consistent, traceable reference material across production batches.
Manufactured under ISO 13485 quality management system in Shenzhen, China. Inter-batch CV <10% across production lots. Each batch released with Certificate of Analysis covering appearance, purity (SEC-HPLC), and functional activity (sandwich ELISA). MOQ 1 mg; gram-scale OEM supply available.
Myoglobin antibody pair validated for acute cardiac panel POCT, emergency department diagnostics, and OEM kit development.
Myoglobin is the early-window component in the 0/2h AMI rule-out protocol. LFA strips using GSA501 + GSA503 enable whole-blood or serum testing at the point of care (ED bedside, ambulance, primary clinic) within 15 minutes, providing the earliest laboratory indicator of myocardial necrosis before troponin becomes detectable.
Clinical guidelines recommend the combined myoglobin/troponin/CK-MB panel for comprehensive AMI diagnosis across the 0–12 hour presentation window. Sekbio's matched myoglobin, cTnI, and CK-MB antibody pairs enable integrated multiplex CLIA panel or multi-line LFA strip development from a single ISO 13485-certified raw material supplier.
Myoglobin is also markedly elevated in rhabdomyolysis (crush injury, extreme exertion, statin myopathy), polymyositis, and dermatomyositis. Quantitative serum or urine myoglobin immunoassay using the GSA501 + GSA503 pair supports monitoring of acute kidney injury risk from myoglobinuria — a critical parameter in trauma and sports medicine settings.
IVD manufacturers developing CE-marked or NMPA-registered myoglobin assays can integrate Sekbio's antibody pair with full ISO 13485-compliant batch documentation, lot-to-lot consistency data, and clinical validation reports (vs Roche ECLIA). Gram-scale OEM supply with custom formulation, buffer exchange, and labelling upon request.
Technical and commercial questions from IVD R&D engineers and procurement teams.
Myoglobin is a 17.8 kDa oxygen-binding heme protein found in cardiac and skeletal muscle cells. After acute myocardial infarction (AMI), myoglobin enters the bloodstream within 1–3 hours — earlier than troponin (4–6 hours) or CK-MB (3–4 hours). This rapid kinetic makes myoglobin the earliest measurable marker of cardiac injury, particularly useful in the critical 0–4 hour window for AMI rule-out.
Sekbio supplies: GSA501 (Mouse Anti-Myoglobin mAb, capture antibody), GSA503 (Mouse Anti-Myoglobin mAb, detection antibody), and TSP006 (Recombinant Human Myoglobin Antigen) for calibrator and positive control preparation. All products are available from MOQ 1 mg with 3-year shelf life.
Sekbio myoglobin antibodies are validated for lateral flow assay fluorescence immunoassay (LFA-FIA) and chemiluminescence immunoassay (CLIA) sandwich formats. Performance has been benchmarked against the Roche Elecsys Myoglobin ECLIA assay for regulatory submission support.
The GSA501 + GSA503 pair has been validated in clinical comparison studies against the Roche Elecsys Myoglobin ECLIA assay, demonstrating equivalent sensitivity and specificity for AMI detection across the 25–3,000 ng/mL clinical range. Correlation reports are available upon request to support CE and NMPA submissions.
MOQ is 1 mg for R&D evaluation. OEM production quantities from 10 mg to gram scale are available. Storage: capture and detection antibodies stable at +2°C to +8°C for short-term use; −20°C for long-term storage. Avoid repeated freeze/thaw cycles. TSP006 antigen requires −20°C ±2°C storage.
Yes. Sekbio offers matched antibody pairs for myoglobin, cardiac Troponin I (cTnI), CK-MB, and NT-proBNP — enabling complete 3- or 4-marker cardiac panel development from a single ISO 13485-certified supplier. Contact info@sekbio.com for the complete cardiac panel datasheet or visit our Cardiac Biomarkers page.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply with our team.