Atellica IM HIV Ag/Ab Combo (CHIV) - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

In vitro diagnostic use in the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group “O”) and type 2 in human serum and plasma (EDTA). The assay is intended to be used as an aid in the diagnosis of individuals (children, adolescents, and adults) with human immunodeficiency virus (HIV) 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.

Functional description

The Atellica IM CHIV assay is a 2-step antigen/antibody sandwich immunoassay in which antigens are bridged by antibody present in the patient sample and antigen (p24) in the sample is bridged by antibody present in the reagents.