Test ID: HBAB    
Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum

Identifying previous exposure to hepatitis B virus

Determining adequate immunity from hepatitis B vaccination

Hepatitis B virus (HBV) infection, also known as serum hepatitis, is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products, eg, blood transfusion and sharing of needles by drug addicts. The virus is also found in virtually every type of human body fluid and has been known to be spread through oral and genital contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but is not commonly transmitted via the transplacental route.

The incubation period for HBV infection averages 60 to 90 days (range of 45-180 days). Common symptoms include malaise, fever, gastroenteritis, and jaundice (icterus). After acute infection, HBV infection becomes chronic in 30% to 90% of infected children <5 years of age and in 5% to 10% of infected individuals > or =5 years of age. Some of these chronic carriers are asymptomatic, while others progress to chronic liver disease, including cirrhosis and hepatocellular carcinoma.

Hepatitis B surface antigen (HBsAg) is the first serologic marker, appearing in the serum 6 to 16 weeks following HBV infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms with the appearance of hepatitis B surface antibody (anti-HBs). Anti-HBs also appears as the immune response following hepatitis B vaccination.

See The Laboratory Approach to the Diagnosis and Monitoring of Hepatitis B Infection in Publications and HBV Infection–Diagnostic Approach and Management Algorithm in Special Instructions.

HEPATITIS B SURFACE ANTIBODY

Unvaccinated: negative

Vaccinated: positive

HEPATITIS B SURFACE ANTIBODY, QUANTITATIVE

Unvaccinated: <5.0 mIU/mL

Vaccinated: > or =12.0 mIU/mL

See Viral Hepatitis Serologic Profiles in Special Instructions.

This assay provides both qualitative and quantitative results.

Positive results usually indicate recovery from acute or chronic hepatitis B virus (HBV) infection, or acquired immunity from HBV vaccination.

Positive results (quantitative hepatitis B surface antibody [anti-HBs] levels of > or =12 mIU/mL) indicate an adequate immunity to hepatitis B from previous HBV infection or HBV vaccination.

Negative results (quantitative anti-HBs levels of <5 mIU/mL) indicate a lack of recovery from acute or chronic hepatitis B or inadequate immune response to HBV vaccination.

Indeterminate results (quantitative anti-HBs levels in the range from > or =5 to <12 mIU/mL) indicate inability to determine if anti-HBs is present at levels consistent with recovery or immunity. Repeat testing is recommended in 1 to 3 months.

See The Laboratory Approach to the Diagnosis and Monitoring of Hepatitis B Infection in Publications and HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions.

Passively acquired hepatitis B surface antibody (anti-HBs) (ie, transfusion of whole blood or plasma, recent immune globulin treatment) can yield positive results without indicating permanent immunity to hepatitis B virus (HBV) infection.

Anti-HBs levels from previous hepatitis B or HBV vaccination may fall below detectable levels over time.

Not useful for diagnosis of acute HBV infection.

Performance characteristics have not been established for the following specimen characteristics:

-Grossly icteric (total bilirubin level of >20 mg/dL)

-Grossly lipemic (triolein level of >3,000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Containing particulate matter

-Cadaveric specimens

1. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol 2001;21:229-237

2. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis 2004;8:267-281

• Viral Hepatitis Serologic Profiles
• HBV Infection-Diagnostic Approach and Management Algorithm