Anti-HBV preS1 Monoclonal Antibody for Hepatitis B Antigen Detection CLIA & LFA IVD Development
HBV preS1 antigen is the N-terminal extension of the Hepatitis B surface antigen (HBsAg), specifically the preS1 region comprising 108 amino acids present exclusively on the large surface protein (LHBs, Large Hepatitis B surface protein). The molecular weight of isolated preS1 peptide is approximately 39–42 kDa; the full LHBs protein ranges from 300–500 kDa when embedded in the viral envelope. Critically, the preS1 domain contains the hepatocyte receptor binding site (NTCP — sodium taurocholate cotransporting polypeptide), making it the essential determinant of viral attachment and infectivity. preS1 antigen appears in serum during the very early phase of HBV infection, preceding both HBeAg seroconversion and ALT elevation, establishing it as the earliest direct viral replication marker available for immunoassay detection.
The clinical significance of preS1 detection is substantial. A positive preS1 result indicates the presence of Dane particles (complete, infectious HBV virions) and confirms active HBV DNA replication. preS1 antigen demonstrates superior sensitivity to HBeAg, with a detection window that opens earlier in the course of acute infection and remains open throughout active replication phases. Crucially, in HBeAg-negative chronic hepatitis B — a major clinical challenge affecting a significant proportion of chronically infected patients who have undergone HBeAg-to-anti-HBe seroconversion — preS1 remains detectable during replication-active phases, enabling monitoring of viral activity that would be invisible to HBeAg-based assays. The WHO estimates approximately 296 million people live with chronic HBV infection globally, with the highest burden concentrated in Africa and the Western Pacific region, driving strong IVD market demand for sensitive HBV markers.
For IVD immunoassay development, preS1 detection is optimally suited for two main formats: CLIA (chemiluminescence immunoassay) sandwich format for high-sensitivity quantitative laboratory testing, and LFA (lateral flow assay) rapid test format for POCT deployment in resource-limited settings and blood bank screening. Sekbio's matched antibody pair — S03-HBV-10 (capture antibody targeting the preS1 capture epitope) and S03-HBV-29 (detection antibody targeting a non-overlapping preS1 epitope) — is engineered for sandwich immunoassay use across ELISA, CLIA, CMIA, and LFA platforms, providing IVD developers with a complete, validated raw material solution for HBV preS1 assay construction.
Two matched anti-HBV preS1 monoclonal antibodies for complete CLIA, CMIA, and LFA sandwich immunoassay development.
| Catalog No. | Product Name | Isotype | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| S03-HBV-10 | Anti-HBV preS1 Monoclonal Antibody (Capture) | Mouse IgG1 | >90% SEC-HPLC | Capture — ELISA, CLIA, CMIA, LFA | −20°C / +2–8°C <1 month |
| S03-HBV-29 | Anti-HBV preS1 Monoclonal Antibody (Detection) | Mouse IgG1 | >90% SEC-HPLC | Detection — ELISA, CLIA, CMIA, LFA | −20°C / +2–8°C <1 month |
Both antibodies supplied in 20 mM PBS, pH 7.4. MOQ 1 mg. OEM quantities (10 mg–gram scale) available. Contact info@sekbio.com for bulk pricing and full COA documentation.
Engineered for the sensitivity and platform versatility required in clinical HBV diagnostics, blood bank screening, and antiviral therapy monitoring.
S03-HBV-10 and S03-HBV-29 are designed as a matched sandwich pair, targeting two distinct, non-overlapping epitopes on the HBV preS1 domain. This dual-clone strategy ensures simultaneous binding without steric interference, maximising assay signal and sensitivity — critical for detecting low-level preS1 during early infection or low-replication chronic HBV states.
Both antibodies are validated for ELISA, CLIA, CMIA (chemiluminescent microparticle immunoassay as used on Abbott ARCHITECT-type platforms), and LFA lateral flow rapid test formats. A single antibody source covers the full spectrum from high-throughput hospital laboratory platforms to point-of-care strip tests for resource-limited settings.
preS1 antigen appears in serum earlier than HBeAg and ALT elevation, providing a wider detection window in acute HBV infection. In HBeAg-negative chronic hepatitis B patients — estimated to represent 30–50% of chronic HBV cases in some regions — preS1 assays detect active viral replication that conventional HBeAg tests miss entirely, giving diagnostic laboratories a critical additional tool.
Affinity-purified antibodies with purity >90% by SEC-HPLC and aggregation <5%. High purity reduces non-specific binding in CLIA microparticle systems and LFA nitrocellulose membranes, improving assay signal-to-noise ratio and lowering the limit of detection for preS1 quantification. Manufactured under ISO 13485 QMS with inter-batch CV <10%.
All HBV preS1 antibodies are manufactured at Sekbio's ISO 13485-certified facility in Shenzhen, China. Full QMS documentation, CoA with every lot, and traceability records support CE IVD, NMPA, and FDA 510(k) regulatory submissions for diagnostic kit manufacturers. Consistent lot performance reduces re-validation burden during OEM scale-up.
Sekbio supplies HBV preS1 antibody pairs to OEM IVD manufacturers across Europe, North America, Korea, Japan, India, and the Middle East. MOQ 1 mg for R&D evaluation; gram-scale commercial supply for kit manufacturing. The 296-million-person chronic HBV population drives sustained demand for Hepatitis B IVD raw materials globally, particularly in Africa and Asia-Pacific.
HBV preS1 antibody pair validated for Hepatitis B diagnosis, viral replication monitoring, blood screening, and POCT kit development.
Chronic HBV infection affects an estimated 296 million people worldwide (WHO 2019 data), with the highest prevalence in sub-Saharan Africa (6.1% HBsAg prevalence) and the Western Pacific (6.2%). preS1 antigen CLIA assays provide a sensitive quantitative marker for confirming active viral replication in both HBeAg-positive and HBeAg-negative chronic hepatitis B. Sekbio's S03-HBV-10/S03-HBV-29 sandwich pair supports CLIA and CMIA assay formats for hospital hepatology laboratory use.
Nucleic acid polymer (NAP) therapies and novel HBV curative regimens aim to eliminate HBsAg and preS1 from serum. preS1 quantitative assays serve as a functional cure endpoint marker, with preS1 clearance preceding or correlating with HBsAg loss. IVD developers building HBV monitoring panels for clinical trial support or routine NUC (nucleoside analogue) therapy monitoring can use Sekbio's antibody pair to develop quantitative preS1 CLIA assays validated against international HBV reference materials.
Blood transfusion safety requires highly sensitive HBV screening to prevent transfusion-transmitted hepatitis B. preS1 antigen assays provide complementary sensitivity to standard HBsAg and anti-HBc screening, particularly for detecting occult HBV infection (OBI) — defined as HBsAg-negative, HBV DNA-positive — where LHBs/preS1 may still be detectable at low levels. Lateral flow or CLIA preS1 assays using Sekbio antibodies can be integrated into blood bank HBV screening panels. Visit our Products page for the full HBV antibody portfolio.
In Africa, Southeast Asia, and parts of South America where chronic HBV prevalence is highest and laboratory infrastructure is limited, point-of-care HBV diagnostics are essential for linking patients to care. LFA rapid tests using Sekbio's S03-HBV-10/S03-HBV-29 antibody pair can be formatted for whole blood or serum with fingerpick sampling, enabling community-level HBV preS1 detection without refrigeration-dependent laboratory equipment. Contact info@sekbio.com for LFA development support.
Technical and commercial questions from IVD R&D engineers and procurement teams.
HBsAg is the collective term for all Hepatitis B surface protein forms — large (LHBs), middle (MHBs), and small (SHBs). HBV preS1 antigen specifically refers to the 108-amino-acid N-terminal preS1 domain found only on LHBs. Because preS1 carries the receptor-binding site for hepatocyte NTCP entry, it is the most direct available indicator of infectious Dane particle presence and active viral replication. preS1 appears earlier than HBeAg in acute infection and remains detectable in HBeAg-negative chronic HBV, offering diagnostic sensitivity advantages over HBsAg and HBeAg in specific clinical scenarios.
Sekbio supplies two HBV preS1 antibodies: S03-HBV-10 (mouse anti-HBV preS1 mAb, Mouse IgG1, 150 kDa, affinity purified, >90% SEC-HPLC, 20 mM PBS, intended for capture in ELISA/CLIA/CMIA/LFA) and S03-HBV-29 (mouse anti-HBV preS1 mAb, Mouse IgG1, 150 kDa, affinity purified, >90% SEC-HPLC, 20 mM PBS pH 7.4, intended for detection in ELISA/CLIA/CMIA/LFA). Both available from MOQ 1 mg with Certificate of Analysis.
S03-HBV-10 and S03-HBV-29 are validated for four IVD platforms: ELISA (standard microplate), CLIA (chemiluminescence immunoassay), CMIA (chemiluminescent microparticle immunoassay, including Abbott ARCHITECT-style platforms), and LFA (lateral flow assay rapid test). The matched pair supports both high-throughput quantitative hospital laboratory testing and point-of-care strip test formats from a single antibody raw material source.
Both antibodies are affinity-purified with purity >90% confirmed by SEC-HPLC. Manufactured under ISO 13485 QMS with inter-batch CV <10%. Each production lot undergoes multi-parameter QC including appearance check, SEC-HPLC purity measurement, and bioreactivity confirmation in a validated sandwich immunoassay system before release. Full Certificate of Analysis is provided with every shipment.
MOQ is 1 mg for R&D evaluation; OEM quantities from 10 mg to gram scale available for commercial kit manufacturing. Storage: −20°C long-term; +2°C to +8°C short-term (≤1 month). Avoid repeated freeze/thaw cycles to preserve activity. Supplied in 20 mM PBS, pH 7.4. Shelf life: 3 years from manufacturing date under recommended storage conditions.
Yes. Sekbio is an ISO 13485-certified manufacturer with an established global OEM supply chain serving IVD kit manufacturers in Europe, North America, Korea, Japan, India, and the Middle East. We provide full batch documentation, CoA, and technical support for CE IVD, NMPA, and FDA regulatory submissions. Contact info@sekbio.com to request a datasheet, sample vials, or discuss OEM pricing. See also our Platforms page for antibody development and conjugation services.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply with our team.