Hepatitis
Point-of-care rapid testing for hepatitis. OEM/ODM manufacturer.
Overview
Viral hepatitis (A/B/C/E) is a major global burden. HBsAg and anti-HCV are the core screening markers; HAV/HEV IgM indicate acute infection.
Clinical Context
Viral hepatitis (A/B/C/E) is a major global burden. HBsAg and anti-HCV are the core screening markers; HAV/HEV IgM indicate acute infection.
Diagnostic Markers & Methods
HBsAg (surface antigen) · anti-HCV (antibody) · HAV IgM · HEV IgG/IgM · combo cassettes.
Antigen vs Antibody
HBsAg is a viral antigen (active infection); anti-HCV is an antibody (exposure, not active infection — needs RNA confirmation).
Diagnostic Workflow
Screen HBsAg + anti-HCV → confirm active infection (HBV DNA / HCV RNA) → stage liver disease and treat.
Testing Window
HBsAg: earliest HBV marker. Anti-HCV: ~4–10 weeks after exposure.
Interpretation
HBsAg positive = HBV infection (acute or chronic). Anti-HCV positive = exposure, NOT active infection — confirm with HCV RNA.
False Negative / Positive Considerations
False negative: anti-HCV window period. False positive: anti-HCV persists after viral clearance.
Confirmatory Testing
Anti-HCV reactive → HCV RNA. HBsAg reactive → HBV DNA/panel.
Testing Settings
Rapid tests suit screening programs and antenatal care; molecular confirmation is lab-based.
Sources
WHO hepatitis testing guidelines; CDC viral hepatitis.
Progene's Take
Position: When sourcing hepatitis tests, separate screening from confirmation — anti-HCV is a screen, not a diagnosis, and your buyers must understand that.
- HBsAg detects active or chronic HBV; anti-HCV only indicates exposure — reflex to HCV RNA is required.
- Blood-bank and antenatal programs run HBsAg/HCV/HIV/syphilis combos for throughput.
- Selling a clear 'screen vs confirm' story protects you and your buyers from misuse.
This is the buyer-advisor view of the technical team — editorial guidance, not a substitute for product IFU or local regulatory requirements.
Frequently Asked Questions
Does a positive HCV antibody test mean active infection?
No — anti-HCV indicates exposure (current or past). Active infection requires confirmation with HCV RNA.
What is the earliest marker of hepatitis B?
HBsAg is the earliest viral antigen marker of acute HBV and a marker of chronic infection.
Can rapid tests distinguish acute from chronic hepatitis B?
No — HBsAg positivity alone cannot distinguish acute from chronic; this requires additional markers (IgM anti-HBc) and clinical context.
Related knowledge
Products (4)
Need a full Hepatitis testing panel? Request datasheets, IFU and OEM/ODM options.