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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 Dxl 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).

The Access anti-HAV assay requires Access anti-HAV (reagent packs), Access anti-HAV Calibrator (C1), and Access anti-HAV QC (QC1-QC2). The Access anti-HAV assay is a two-step competitive immunoassay. During incubation, the anti-HAV antibodies present in the patient sample bind to the coated antigen. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A monoclonal anti-HAV antibody alkaline phosphatase conjugate is added to the reaction vessel and the conjugate competes with the bound patient antibodies to affix the HAV antigen coated on the particles. After a second incubation and wash step, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cutoff value defined during calibration. The Qualitative assessment is automatically determined from a stored calibration.

Quality control (QC) materials simulate the characteristics of patient samples and are essential for monitoring the system performance of the Access anti-HAV immunoassay. In addition, they are an integral part of good laboratory practices. When performing assays with Access reagents for anti-HAV, include quality control materials to validate the integrity of the assay. The assayed values should fall within the acceptable range if the test system is working properly.

The Access anti-HAV reagents are provided in liquid ready-to-use format designed for optimal performance on the Beckman Coulter DxI 9000 Access Immunoassay Analyzer only. Each reagent kit contains two reagent packs. The Access anti-HAV Calibrator kit contains one vial, and the Access anti-HAV QC kit contains three vials, each of anti-HAV positive control and anti-HAV negative control. Other items needed to run the assay include Lumi-Phos PRO (chemiluminescent substrate) and UniCel DxI Wash Buffer II.

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