HBV Surface Antigen (HBsAg) Quantitative, Monitoring

For monitoring the progression of chronic hepatitis B and their response to antiviral therapy. This Quantitative detection of Hepatitis B virus Surface Antigen (HBSAg) in human sera incorporates the modified FDA approved ARCHITECT HBsAg test one-step chemiluminescent microparticle immunoassay (CMIA).

The performance characteristics of the test were determined by the University of Washington Department of Laboratory Medicine and Pathology. The modified version has not been cleared or approved by the US Food and Drug Administration.

Note: This test should only be ordered in individuals with chronic Hepatitis B, confirmed positive for HBV Surface Antigen (HBSAg).

For initial HBV diagnosis, see Hepatitis B Surface Antigen (HBsAg) with reflex to PCR for REACTIVE [HBSAG] or Hepatitis B Surface Antigen without PCR reflex for REACTIVE [HBSAGX].

Preferred: 5 mL blood in GOLD SST tube

Also acceptable: 5 mL blood in ORANGE RST or RED TOP.

GOLD SST tube: Specimens may be stored on or off the clot, red blood cells, or separator gel for up to 3 days at room temperature (15-30°C) or up to 7 days at 2-8°C. If testing will be delayed more than 3 days for specimens stored at room temperature or more than 7 days for specimens stored at 2-8°C, remove serum from the clot, red blood cells, or separator gel and store at -20°C or colder. Avoid more than three freeze/thaw cycles.

Unacceptable samples: Cord blood, neonatal specimens, cadaver specimens, heat-inactivated specimens, or body fluids such as saliva, urine, amniotic fluid, or pleural fluid. Specimens with obvious microbial contamination or that are grossly hemolyzed.