Siemens Atellica™ IM Hepatitis C (aHCV)

The Atellica® IM Hepatitis C (aHCV) assay is for in vitro diagnostic use in the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) in human serum and plasma (EDTA, lithium heparin, and sodium heparin) using the Atellica® Analyzer. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals (neonates, children, adolescents, and adults) with symptoms of hepatitis and in individuals at risk for hepatitis C infection. 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.