Erythropoietin (EPO) Monoclonal Antibody for Anemia & Renal Disease CLIA IVD Development
Erythropoietin (EPO) is a glycoprotein hormone and the primary regulator of erythropoiesis — the process of red blood cell production in bone marrow. EPO is produced predominantly (~90%) by peritubular interstitial cells in the renal cortex, with a minor contribution from pericentral hepatocytes in the liver. The mature EPO protein has a total molecular weight of approximately 34 kDa, comprising an 18 kDa protein core and extensive glycosylation (approximately 40% of molecular weight by mass). EPO exerts its effect by binding to erythropoietin receptors (EPOR) on erythroid progenitor cells (burst-forming unit erythroid, BFU-E, and colony-forming unit erythroid, CFU-E) in bone marrow, activating JAK2/STAT5 signaling pathways that promote differentiation, proliferation, and survival of red blood cell precursors. Normal serum EPO concentrations in healthy adults range from 3–29 IU/L (equivalent to mIU/mL), with physiological upregulation during hypoxia, high altitude, or blood loss.
EPO quantification has multiple critical clinical applications. In chronic kidney disease (CKD) — affecting approximately 800 million people globally — impaired renal EPO production leads to renal anemia, the most common and debilitating complication of CKD. EPO levels <10 IU/L in an anemic CKD patient confirm relative EPO deficiency and establish the indication for erythropoiesis-stimulating agent (ESA) therapy. EPO monitoring is also essential in polycythemia vera (PV) — a myeloproliferative neoplasm where EPO is characteristically suppressed to <3 IU/L due to autonomous EPO-independent erythrocyte production — enabling differential diagnosis from secondary erythrocytosis (where EPO is elevated). Additionally, recombinant human EPO (rHuEPO, including epoetin alfa, epoetin beta, darbepoetin alfa) therapy response monitoring requires serum EPO quantification to optimize dosing. In sports medicine, EPO doping detection in competitive athletics uses both immunoassay-based serum EPO quantification and isoelectric focusing-based urine methods to identify illicit rHuEPO use.
For IVD assay development, EPO quantification uses a sandwich immunoassay format. EPO-19210X1 (also catalogued as MAB10-72K) is a recombinant mouse anti-human EPO monoclonal antibody, clone H6C7, IgG1κ isotype, produced in CHO (Chinese hamster ovary) cells using Sekbio's recombinant antibody expression platform. CHO expression delivers superior batch-to-batch consistency compared to hybridoma-based manufacturing, critical for IVD kit production requiring tight lot-to-lot performance specifications. The antibody achieves ≥95% purity by SDS-PAGE and a molecular weight of 146,602 Da. It is validated for CLIA sandwich assay (the primary clinical platform for serum EPO measurement), ELISA (laboratory and research applications), and LFA (point-of-care rapid EPO screening). CHO system expression ensures full cross-reactivity with both endogenous human EPO and rHuEPO therapeutic preparations, enabling accurate EPO measurement across all clinical use cases — from renal anemia diagnosis to ESA therapy monitoring.
Recombinant anti-human EPO monoclonal antibody (clone H6C7, CHO expressed) for CLIA, ELISA, and LFA sandwich immunoassay development.
| Catalog No. | Product Name | Clone | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| EPO-19210X1 | Mouse Anti-Human EPO Monoclonal Antibody (IgG1κ, CHO) | H6C7 | ≥95% SDS-PAGE | ELISA / CLIA / LFA — Sandwich Assay | −20°C / +2–8°C |
Supplied in PBS pH 7.4. MOQ 1 mg. Also catalogued as MAB10-72K. OEM quantities available. Contact info@sekbio.com for bulk pricing and technical development support.
CHO-expressed recombinant EPO antibody engineered for the sensitivity and consistency required in clinical renal anemia CLIA diagnostics.
EPO-19210X1 is produced in CHO (Chinese hamster ovary) cells using recombinant antibody expression technology — not from hybridoma cell lines. CHO expression eliminates the genetic instability inherent in hybridoma-derived antibody production, delivering superior batch-to-batch consistency, defined sequence, and stable long-term manufacturing. This is critical for IVD kit manufacturers who require identical antibody performance across years of production for regulatory compliance and re-lot validation purposes.
Clone H6C7 is a well-characterized anti-human EPO monoclonal antibody clone with validated sensitivity covering the clinically critical EPO range of 3–29 IU/L (normal reference range), <3 IU/L (polycythemia vera suppression), and up to several hundred IU/L (post-ESA therapy or secondary erythrocytosis). The H6C7 epitope specificity ensures full cross-reactivity with both endogenous human EPO and all major rHuEPO therapeutic preparations (epoetin alfa, epoetin beta, darbepoetin alfa), enabling accurate EPO quantification in treatment-monitoring applications.
EPO-19210X1 is validated for CLIA (primary clinical platform for quantitative serum EPO measurement in hospital nephrology and hematology laboratories), ELISA (research and pharmaceutical applications), and LFA (point-of-care rapid EPO screening). This multi-platform validation enables a single antibody source for both quantitative CLIA analyzer kit development and rapid test strip development, simplifying raw material sourcing and reducing IVD development costs.
EPO-19210X1 achieves ≥95% purity by SDS-PAGE (affinity purified), minimizing non-specific binding in CLIA microparticle assays. High purity is particularly important for EPO CLIA because the clinical EPO range (3–29 IU/L) is narrow, and distinguishing normal from pathological EPO values requires very low background signal and high assay precision. The well-defined antibody MW of 146,602 Da enables precise labeling ratios for CLIA enzyme conjugation or fluorescent labeling.
CKD affects approximately 800 million people globally (10–15% of the adult population), with renal anemia as a near-universal complication in advanced CKD stages (GFR <30 mL/min). EPO CLIA kits are essential tools in nephrology clinical laboratories worldwide for renal anemia diagnosis, ESA treatment initiation, and dose optimization. The global EPO testing market is driven by rising CKD prevalence, aging populations, and expanding ESA therapy use in China, India, Europe, and Southeast Asia — all priority IVD markets for Sekbio's OEM supply clients.
MOQ 1 mg for R&D evaluation; gram-scale OEM production available. ISO 13485-certified manufacturing in Shenzhen ensures quality compliance for CE-marked CLIA kit production. Sekbio's CHO expression platform supports consistent large-scale EPO antibody production with defined batch release criteria. We support CE, NMPA, and FDA regulatory submission documentation. Contact info@sekbio.com to discuss EPO CLIA kit development, OEM supply terms, and technical support services.
EPO sandwich immunoassay antibody validated for renal anemia diagnosis, ESA therapy monitoring, polycythemia differential diagnosis, and anti-doping kit development.
Chronic kidney disease is the primary clinical indication for serum EPO measurement. In CKD patients with hemoglobin <10–11 g/dL and EPO <10 IU/L, renal anemia secondary to insufficient EPO production is confirmed, establishing indication for ESA therapy. KDIGO (Kidney Disease: Improving Global Outcomes) guidelines and ESC/ERA-EDTA guidelines both recommend EPO measurement in anemic CKD patients for differential diagnosis and treatment planning. EPO-19210X1-based CLIA kits support nephrology laboratory EPO quantification for the 800+ million global CKD patients requiring iron and anemia management. IVD manufacturers targeting the CKD diagnostics market can use Sekbio's EPO antibody for high-sensitivity CLIA assay development.
ESA therapy (recombinant human EPO: epoetin alfa, epoetin beta, darbepoetin alfa, methoxy-polyethylene glycol-epoetin beta) is the standard treatment for renal anemia in CKD, cancer-related anemia, and post-chemotherapy anemia. Monitoring EPO levels during ESA therapy enables dose optimization, hypertension risk management, and detection of ESA hypo-responsiveness (inadequate hemoglobin response despite adequate EPO dosing). EPO-19210X1 clone H6C7 cross-reacts with all major rHuEPO preparations, enabling accurate total EPO quantification in ESA-treated patients. CLIA kits built on this antibody support clinical pharmacology and therapeutic drug monitoring applications in hospital nephrology and oncology departments.
Polycythemia vera (PV) is a myeloproliferative neoplasm driven by JAK2 V617F mutation, characterized by autonomous EPO-independent erythrocytosis and characteristically suppressed serum EPO (<3 IU/L or below the lower normal limit). Measuring serum EPO is a key diagnostic criterion in the WHO 2022 classification of PV: EPO below normal differentiates PV from secondary erythrocytosis (where EPO is normal to elevated due to hypoxia, high altitude, or EPO-secreting tumors). High-sensitivity CLIA assays — capable of accurately measuring EPO at <3 IU/L — are essential for PV diagnosis. EPO-19210X1 enables CLIA kit development with the sensitivity required for sub-normal EPO quantification in hematology diagnostic panels.
EPO doping in competitive athletics (blood doping) involves illicit administration of rHuEPO to enhance oxygen-carrying capacity and endurance performance. Serum EPO immunoassay quantification is one component of the World Anti-Doping Agency (WADA)-approved EPO doping detection framework, used in conjunction with biological passport hematological parameters and urine-based isoelectric focusing EPO tests. Sports medicine laboratories and anti-doping reference laboratories developing EPO immunoassay components can use EPO-19210X1 for high-specificity serum EPO ELISA or CLIA assay development. Visit our Platforms page or contact our team for custom development support.
Technical and commercial questions from IVD R&D engineers and procurement teams developing EPO diagnostic assays.
EPO (Erythropoietin) is a glycoprotein hormone (~34 kDa) produced primarily by kidney peritubular cells (~90%) that stimulates red blood cell production in bone marrow via EPOR/JAK2/STAT5 signaling. Normal serum EPO is 3–29 IU/L. Key clinical applications: renal anemia diagnosis in CKD (EPO <10 IU/L confirms relative EPO deficiency), polycythemia vera diagnosis (EPO <3 IU/L, characteristically suppressed), rHuEPO treatment monitoring, and sports anti-doping EPO detection. With ~800 million global CKD patients, EPO CLIA testing is a high-volume clinical laboratory application worldwide.
Clone H6C7 is the anti-human EPO monoclonal antibody clone in EPO-19210X1. It is a recombinant IgG1κ antibody expressed in CHO cells (MW 146,602 Da), providing superior batch-to-batch consistency versus hybridoma-derived antibodies. H6C7 is validated for EPO quantification in CLIA sandwich assays covering the clinically critical 3–29 IU/L normal range and sub-normal (<3 IU/L) EPO detection. CHO expression ensures full cross-reactivity with both endogenous EPO and rHuEPO therapeutic preparations.
EPO-19210X1 (clone H6C7) is validated for: CLIA (primary clinical platform for quantitative serum EPO measurement — high sensitivity required for 3–29 IU/L range), ELISA (laboratory and pharmaceutical research), and LFA (lateral flow for point-of-care rapid EPO screening). Multi-platform validation enables a single antibody source for both hospital laboratory quantitative CLIA and rapid test development. CLIA is the recommended platform for clinical EPO quantification due to the narrow normal range requiring high assay precision.
EPO-19210X1 long-term storage: −20°C. Short-term storage: +2°C to +8°C (less than 1 month). Supplied in PBS pH 7.4. Avoid repeated freeze/thaw cycles. Purity ≥95% by SDS-PAGE. MW 146,602 Da (IgG1κ, CHO expressed, affinity purified). Full Certificate of Analysis provided with each shipment. Also catalogued as MAB10-72K.
MOQ is 1 mg for R&D evaluation. OEM quantities from 10 mg to gram scale are available for IVD kit manufacturing. Sekbio's ISO 13485-certified CHO expression platform provides consistent large-scale EPO antibody supply for CE-marked renal anemia CLIA kit production. Contact info@sekbio.com to discuss EPO CLIA kit development, OEM supply agreements, and bulk pricing. We serve IVD manufacturers in Europe, North America, China, South Korea, Japan, and Southeast Asia.
Yes. EPO-19210X1 (clone H6C7, CHO expressed) fully cross-reacts with recombinant human EPO therapeutic preparations including epoetin alfa (Epogen, Procrit), epoetin beta (NeoRecormon), darbepoetin alfa (Aranesp), methoxy-PEG-epoetin beta (Mircera), and biosimilar EPO products. This cross-reactivity is essential for rHuEPO treatment monitoring — where accurate total EPO measurement (endogenous + therapeutic) is required for dose optimization and treatment response assessment in CKD and cancer-related anemia. Contact info@sekbio.com for detailed cross-reactivity data and application notes.
Request the full technical datasheet, clone H6C7 specifications, or discuss OEM CLIA kit development with our team.