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The Access anti-HAV IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, and tripotassium (K3) EDTA] using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HAV IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis A virus (HAV) infection in individuals with signs and symptoms of hepatitis A virus, when used in conjunction with other serological and clinical information.

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 IgM assay requires Access anti-HAV IgM (reagent packs), Access anti-HAV IgM Calibrator (C1), and Access anti-HAV IgM QC (QC1-QC2). The Access anti-HAV IgM assay is a two-step sandwich immunoassay. Paramagnetic particles coated with anti-human IgM monoclonal antibody and prediluted sample are added to a reaction vessel. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. HAV antigen and anti-HAV monoclonal antibody alkaline phosphatase conjugate are added. HAV antigen complexed to the conjugate binds to the IgM antibodies captured on the particles. A second separation and wash step removes unbound conjugate.

A chemiluminescent substrate is then added to the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cut-off value defined during calibration of the instrument. 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 IgM immunoassay. In addition, they are an integral part of good laboratory practices. When performing assays with Access reagents for anti-HAV IgM, 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 IgM 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 IgM Calibrator kit contains one vial, and the Access anti-HAV IgM QC kit contains three vials each of anti-HAV IgM positive control and anti-HAV IgM 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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