Method Description

The Elecsys Anti-HAV (hepatitis A virus) IgM assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HAV-specific IgM antibody (anti-HAV IgM) in the patient’s serum sample is pretreated with anti-Fdy reagent to block specific IgG in the presence of monoclonal anti-HAV antibodies labeled with ruthenium complex. After addition of biotinylated monoclonal human-IgM-specific antibodies, HAV antigen, and streptavidin-coated microparticles, patient’s anti-HAV IgM form a sandwich complex with the HAV antigen and the ruthenium-labeled anti-HAV antibody which becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, and unbound substances are washed away. Voltage is applied to the electrode then induces chemiluminescent emissions that are measured by a photomultiplier. Test result is determined automatically by the assay-specific software program by comparing the electrochemiluminescence signal generated from the patient’s sample to the cutoff index value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HAV IgM. Roche Diagnostics; v5.0, 11/2022)