Test Code LAB1242 Hepatitis B Core Total Antibodies
Intended Use
HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human neonatal, pediatric, and adult serum or plasma. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.
Methodology
The ADVIA Centaur HBc Total assay is a two wash antigen sandwich immunoassay in which antigens are bridged by antibody present in the patient sample. The Solid Phase contains a preformed complex of streptavidin coated microparticles and biotinylated recombinant HBc antigen and is used to capture anti-HBc in the patient sample. The Lite Reagent contains recombinant HBc antigen labeled with acridinium ester and is used to detect anti-HBc in the sample. Solid Phase and Chaotrope Reagent are added to the sample, followed by Ancillary Reagent and Lite Reagent. Antibody-antigen complexes will form if anti-HBc antibodies (IgM and IgG) are present in the sample.
Performing Laboratory
RCH
Specimen Requirements
Preferred: Serum
Container/tube: Plain, red-top or gold, serum gel tube
Acceptable: Plasma (heparinized)
Container: Lt Green/Mint top (lithium heparin) tube
Specimen Volume: 1.0 mL (minimum volume 0.1 mL)
Collection Instructions: Forward promptly
Specimen Stability
Ambient: 2 days
Refrigerated: 7 days
Frozen (-20ºC): Aliquots are stable for up to 5 freeze/thaw cycles
Day(s) Test Set Up
Monday through Sunday
Test Classification and CPT Coding
86704