The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of total antibodies (anti-HAV IgG and IgM) to hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, sodium citrate, acid-citrate-dextrose (ACD), and citrate phosphate-dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer.The Access anti-HAV assay is indicated as an aid in the diagnosis of current or past HAV infection in persons with risk factors and/or signs or symptoms of hepatitis A, when used in conjunction with other serological and clinical information. The assay may also be used in the identification of HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients.This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps).
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis A virus in a clinical specimen, using a chemiluminescent immunoassay method.