Atellica IM HBc Total 2 (HBcT2) - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

In vitro diagnostic use in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBV) in human serum or plasma. This assay can be used as an aid in the diagnosis of individuals (neonates, children, adolescents, and adults) 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 be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The assay is intended for testing serum and plasma specimens to screen donors whose blood or blood products are intended for transfusion or for further manufacture, or to screen donors whose cells, tissues, and organs are intended for transplant. Specimens may be obtained while the donor's heart is still beating, or from cadaveric (non‑heart‑beating) donors.

Functional description

The Atellica IM HBcT2 assay is a 2‑wash antigen sandwich immunoassay in which antigens are bridged by antibody present in the patient sample.