H5N1 Avian Influenza Monoclonal Antibody for Rapid Test & CLIA IVD Development
H5N1 is a highly pathogenic avian influenza (HPAI) virus, a subtype of Influenza A defined by its surface glycoproteins: hemagglutinin subtype 5 (H5) and neuraminidase subtype 1 (N1). The H5 hemagglutinin mediates viral binding to sialic acid receptors on host cells and is the primary target for both antigen-based diagnostic assays and neutralising antibody responses. H5N1 circulates endemically in wild waterfowl (its natural reservoir) and periodically spills over into domestic poultry populations with devastating mortality rates. Cross-species transmission to humans, while currently inefficient, carries an extraordinarily high case fatality rate — the WHO reports approximately 60% mortality in confirmed human H5N1 infections, the highest of any influenza subtype under surveillance. The ongoing evolution of H5N1 into multiple distinct clades (with Clade 2.3.4.4b dominating recent outbreaks) requires diagnostic antibodies that target conserved HA epitopes to maintain broad detection coverage.
The global public health threat posed by H5N1 is underscored by its pandemic potential. Since the first documented human infections in Hong Kong in 1997, over 900 human cases have been reported globally (WHO data through 2024), with infections recorded in Asia, the Middle East, Africa, and Europe. The unprecedented 2024 outbreak of H5N1 in US dairy cattle herds, accompanied by a cluster of human cases among farm workers with mild-to-moderate disease, triggered renewed global pandemic preparedness review by WHO, FAO, and the US CDC. The detection of H5N1 in mammals previously considered low-risk hosts underscores the unpredictable host range of this virus. Rapid and accurate diagnosis is critical for case confirmation, initiation of antiviral therapy (oseltamivir), implementation of infection control measures, and epidemiological surveillance to monitor potential human-to-human transmission chains.
For IVD developers, H5N1 rapid antigen detection using lateral flow assay (LFA) technology is the most operationally deployable diagnostic tool for primary health facilities, farms, and field surveillance teams. LFA strips using Sekbio's H5N1-W061/W062 antibody pair target conserved epitopes on the H5 hemagglutinin protein, providing specific detection of H5N1 antigen in nasal swab or pharyngeal samples with results in 15 minutes — no laboratory infrastructure required. For higher-sensitivity confirmatory testing, CLIA sandwich immunoassay format using the same antibody pair offers quantitative H5N1 antigen measurement suitable for hospital infectious disease laboratories. Both applications are supported by a single matched antibody source from Sekbio.
Two matched anti-H5N1 monoclonal antibodies for complete LFA, CLIA, and ELISA sandwich immunoassay development targeting H5 hemagglutinin.
| Catalog No. | Product Name | Isotype | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| H5N1-W061 | Mouse Anti-H5N1 Monoclonal Antibody (Capture) | Mouse IgG1 | ≥95% SDS-PAGE | Capture — LFA, CLIA, ELISA | −20°C / +2–8°C ≤1 week |
| H5N1-W062 | Mouse Anti-H5N1 Monoclonal Antibody (Detection) | Mouse IgG1 | ≥95% SDS-PAGE | Detection — LFA, CLIA, ELISA | −20°C / +2–8°C ≤1 week |
Both antibodies supplied in 10 mM PBS, pH 7.4 (mouse ascites-derived). MOQ 1 mg. OEM quantities (10 mg–gram scale) available for pandemic preparedness and commercial kit manufacturing. Contact info@sekbio.com for full COA and pricing.
Engineered for the sensitivity and specificity required in clinical H5N1 diagnosis, poultry surveillance, and pandemic preparedness stockpiling.
H5N1-W061 and H5N1-W062 are selected as a matched antibody pair for sandwich immunoassay use, with confirmed non-overlapping epitope binding on the H5 hemagglutinin protein. The paired format enables simultaneous capture and signal antibody binding for maximum sensitivity in LFA lateral flow strip format and CLIA quantitative platforms — both critical for H5N1 rapid test performance.
Both antibodies are validated for LFA (lateral flow rapid test), CLIA (chemiluminescence immunoassay), and ELISA formats. LFA is the primary deployment format for field-based H5N1 surveillance and emergency clinical use; CLIA provides high-sensitivity quantitative testing for hospital reference laboratories. A single antibody pair serves both use cases.
H5N1-W061/W062 are raised against conserved epitopes on the H5 hemagglutinin globular head domain, the primary immunodominant antigen for H5N1 detection assays. Targeting conserved regions provides broad cross-reactivity across H5N1 clades (2.1, 2.2, 2.3.4.4b) and related H5 subtypes, reducing the risk of false-negative results as H5N1 continues to evolve antigenically.
Purity ≥95% confirmed by SDS-PAGE. High-purity antibodies are essential for consistent conjugation efficiency in colloidal gold LFA development and for reproducible CLIA signal generation. Lower aggregation translates to reduced non-specific binding and superior assay signal-to-noise ratio. Manufactured under ISO 13485 QMS with inter-batch CV <10%.
H5N1 pandemic preparedness is a national and institutional priority for governments, public health agencies, and healthcare systems worldwide. Sekbio can support strategic stockpile procurement of H5N1 antibody pairs at scale, with consistent lot-to-lot performance under ISO 13485 QMS. Advance supply agreements and custom lot reservation are available for pandemic response programmes.
Sekbio supplies H5N1 antibody pairs to OEM IVD manufacturers across Europe, Asia, and the Americas for commercial H5N1 rapid test and CLIA kit development. ISO 13485-compliant batch documentation supports CE IVD, WHO EUL, and national regulatory submissions. MOQ 1 mg for R&D; gram-scale for production. Established export logistics to 30+ countries.
H5N1 antibody pair validated for rapid antigen detection, clinical diagnosis, pandemic preparedness stockpiling, and poultry surveillance kit development.
Early detection of H5N1 in domestic poultry flocks is critical for preventing epizootic spread and minimising culling scale. Veterinary LFA rapid tests using Sekbio H5N1-W061/W062 antibody pair can be deployed directly on farms for cloacal swab or tissue antigen detection in chickens, ducks, and turkeys, delivering results in 15 minutes without laboratory access. The 2024 US dairy cattle H5N1 outbreak highlighted the urgent need for on-site rapid tests in agricultural settings beyond traditional poultry farms, including dairy cattle herds.
For patients presenting with febrile respiratory illness and a history of poultry contact or travel to H5N1-endemic regions, rapid antigen testing at point-of-care enables early case identification and timely initiation of oseltamivir therapy (within 48 hours of symptom onset for maximum efficacy). H5N1 LFA rapid tests using Sekbio's antibody pair can be formatted for nasopharyngeal swab samples with 15-minute readout, enabling emergency department and fever clinic deployment. CLIA format provides higher sensitivity for samples with lower viral load.
WHO, national public health agencies (US HHS BARDA, EU HERA), and healthcare institutions maintain strategic reserves of H5N1 diagnostic reagents as part of pandemic influenza preparedness plans. Sekbio's H5N1 antibody pairs can be procured in large-scale lots with extended shelf life data under ISO 13485 QMS for strategic reserve programmes. Advance purchase agreements and scheduled delivery programmes are available. Contact info@sekbio.com for strategic supply discussions.
While LFA provides rapid field-deployable screening, CLIA sandwich immunoassay using the H5N1-W061/W062 antibody pair offers significantly higher analytical sensitivity for confirmatory testing of screen-positive or low-viral-load samples. Hospital-based CLIA H5N1 antigen assays support quantitative viral load monitoring during antiviral treatment and are valuable for clinical research characterising the natural history of human H5N1 infection. Visit our Platforms page for CLIA assay development services, or contact us for technical support.
Technical and commercial questions from IVD R&D engineers and procurement teams.
H5N1 is a highly pathogenic avian influenza (HPAI) Influenza A subtype defined by H5 hemagglutinin and N1 neuraminidase. Its natural reservoir is wild waterfowl, but it can infect domestic poultry and humans with lethal outcomes. WHO reports approximately 60% case fatality in confirmed human cases. Since 1997, 900+ human cases have been documented across 23 countries. The 2024 US dairy cattle outbreak and associated human cases elevated H5N1 to the top of global pandemic preparedness agendas. WHO classifies H5N1 as a Priority Pathogen for pandemic preparedness planning and rapid diagnostic development.
Sekbio supplies: H5N1-W061 (mouse anti-H5N1 mAb, IgG1, mouse ascites-derived, ≥95% SDS-PAGE, 10 mM PBS pH 7.4, intended for LFA/CLIA/ELISA capture) and H5N1-W062 (mouse anti-H5N1 mAb, IgG1, mouse ascites-derived, ≥95% SDS-PAGE, 10 mM PBS pH 7.4, intended for LFA/CLIA/ELISA detection). Both available from MOQ 1 mg with Certificate of Analysis.
H5N1-W061 and H5N1-W062 are validated for three platforms: LFA (lateral flow assay/rapid test) — the primary intended use for field and clinical point-of-care H5N1 antigen detection; CLIA (chemiluminescence immunoassay) — for high-sensitivity quantitative hospital laboratory testing; and ELISA — for research and development use. Both antibodies function as matched capture/detection pairs in sandwich format across all three platforms.
H5N1-W061/W062 target conserved epitopes on H5 hemagglutinin to maximise cross-clade reactivity. H5N1 has diversified into multiple clades (1, 2.1, 2.2, 2.3.4.4b among the most clinically relevant), and targeting conserved HA regions reduces the risk of false-negative results due to antigenic drift. Developers should validate reactivity against their target clade using characterised reference antigens. Contact info@sekbio.com for cross-reactivity characterisation data and technical support.
MOQ is 1 mg for R&D and assay development; OEM quantities from 10 mg to gram scale available for commercial production and pandemic preparedness stockpiling. Storage: −20°C long-term; +2°C to +8°C short-term (≤1 week). Supplied in 10 mM PBS, pH 7.4. Avoid repeated freeze/thaw cycles. Shelf life and specific lot data provided on Certificate of Analysis with each shipment.
Yes. Sekbio operates ISO 13485-certified manufacturing capable of producing gram-scale lots of H5N1 antibody pair with consistent performance and full batch documentation for strategic reserve programmes. We support procurement by government agencies, national laboratories, and institutional IVD manufacturers. Advance purchase agreements and scheduled supply arrangements are available. Contact info@sekbio.com to discuss strategic supply or OEM pricing. See our Platforms page for conjugation and custom antibody services.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply with our team.