Hepatitis B Serum

Hepatitis B Serum for Infectious Disease and Virology Research

Our Hepatitis B Serum is sourced from IRB-consented donors clinically diagnosed with hepatitis B. Each sample is processed and frozen within 24 hours of collection to preserve viral antigens, antibodies, and nucleic acid for serological and virological analysis. Serum is acellular, and is the standard matrix for HBV serology and viral load measurement.

HBV Virology and Why Serum

Hepatitis B is a chronic viral infection of the liver, caused by hepatitis B virus, a small partially double-stranded DNA virus with a strict hepatocyte tropism. Its biology is defined by persistence, not by autoimmunity:

  • Persistence via cccDNA. HBV establishes a stable episomal covalently closed circular DNA reservoir in the hepatocyte nucleus, which current therapy suppresses but does not eliminate — the central obstacle to cure
  • Serology is unusually informative. HBsAg, anti-HBs, HBeAg, anti-HBe, and anti-HBc in IgM and IgG classes together distinguish acute from chronic infection, resolved infection, and vaccine-induced immunity
  • Chronic infection moves through recognised phases defined by HBeAg status, HBV DNA level, and degree of hepatic inflammation, so phase annotation matters more than diagnosis alone
  • Liver damage is immune-mediated — HBV is not directly cytopathic; hepatocyte injury reflects cytotoxic T-cell responses, and chronic infection is characterised by T-cell exhaustion and a blunted antiviral response
  • Genotypes A to J differ in geographic distribution, clinical course, and treatment response, and long-standing chronic infection carries risk of cirrhosis and hepatocellular carcinoma
  • Why serum: serum supports quantitative HBsAg and antibody immunoassays, HBV DNA quantification and sequencing, and biomarker work toward functional cure, whose principal endpoint is sustained HBsAg loss

Donor Stratification Available

  • HBeAg status: HBeAg-positive or HBeAg-negative chronic infection
  • Viral load category and quantitative HBsAg level where clinically measured
  • Treatment status: treatment-naive, on nucleos(t)ide analogue therapy, or previously treated
  • Liver disease stage, including presence of cirrhosis where documented
  • Co-infection status, including hepatitis C, hepatitis D, or HIV
  • Genotype where clinically determined; age, sex assigned at birth, and race/ethnicity
  • Matched healthy and vaccinated (anti-HBs positive) controls available

Product Features

  • Collected from clinically confirmed hepatitis B donors
  • Processed and frozen within 24 hours of collection
  • Research Use Only (RUO)
  • Standard and custom aliquot volumes available
  • Serial collections from the same donor available on request
  • IRB-approved protocols with documented consent
  • Samples contain infectious virus and must be handled under appropriate biosafety precautions

De-identified Donor Data

  • Diagnosis confirmation, with serological marker results where documented
  • Age, sex assigned at birth, and ethnicity
  • Donor-reported allergy and infectious disease history, including co-infections
  • Treatment history and liver function results available on request

Applications

  • HBsAg, anti-HBs, HBeAg, anti-HBe, and anti-HBc immunoassay development and validation
  • Quantitative HBsAg and HBV DNA assay development
  • Molecular diagnostic and viral load platform verification
  • HBV genotyping and sequence variation research
  • Serological reference and quality control panel construction
  • Functional cure biomarker discovery and treatment response studies
  • Vaccine immunogenicity and seroconversion research using paired control cohorts
  • Liver fibrosis and hepatocellular carcinoma biomarker research in chronic infection

Other Hepatitis B Specimen Types

Compliance and Quality Assurance

  • IRB-approved and HIPAA-compliant protocols
  • Electronic informed consent with 21 CFR Part 11-compliant e-signatures
  • Documentation support available for regulatory review

Ordering and Customization

Hepatitis B serum is available in standard and custom volumes. For pricing, international orders, or documentation requirements, please email learnmore@sanguinebio.com to ensure compatibility with your country’s regulations. For healthy-donor controls and the full specimen range, see our human serum collection.

Protocols & Documentation

  • Serum Isolation

    Protocol for serum preparation from whole blood, including collection handling, clarification, and quality documentation.

    Download
  • Informed Consent Form (ICF)

    Available upon request — confirms donor consent for research use and downstream commercialization.

Serum

Frequently Asked Questions

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Are samples IRB approved?

1 Answer

YES – All collections are conducted under IRB-approved protocols and electronic informed consent. Sanguine utilizes Advarra and WCG IRB for oversight.

YES – all our products are research use only (RUO).

Storage depends on sample type but often cryopreserved samples stored in liquid nitrogen can be stored for years.

Extensive customization is available. To discuss your project request a quote or email us at learnmore@sanguinebio.com.

Sanguine offers flexible prospective collection services tailored to fit your research. For more information and to request a quote, please see: our prospective biospecimen collection services page.

Timelines depend on condition, sample type, and I/E criteria but we often start collection within 2 weeks of signed agreement.

YES – we have in-stock inventory. You can also email us at learnmore@sanguinebio.com as we continually get new samples in our inventory.

Each sample from a different individual – Unique donor means each sample comes from a different person, ensuring biological diversity in your study.

YES – Unique donors can be specified and guaranteed based on your requirements.

For information about sample quality, please see: Quality and Compliance

YES – “IRB-approved collection protocols” and IRB approval documentation available upon request. Sanguine utilizes two internationally-recognized IRBs (Advarra and WCG IRB) for review and approval.

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Need a custom Serum cohort?

Our scientific team can scope prospective collections with donor-specific I/E criteria, typically starting within 2 weeks of agreement.

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