Elecsys Anti-HAV IgM

The Elecsys Anti-HAV IgM is an immunoassay that detects IgM antibodies to hepatitis A virus in serum and plasma samples from adults and pediatric patients (ages 2–21 years) with signs and symptoms of hepatitis or at risk for hepatitis A infection. It is used as an aid in diagnosing acute or recently acquired hepatitis A virus infections and runs on cobas e immunoassay analyzers using electrochemiluminescence technology.

The Elecsys Anti-HAV IgM uses a μ-capture sandwich immunoassay principle based on monoclonal antibodies and streptavidin-coated magnetic microparticles, generating signal via electrochemiluminescence. The predicate Access anti-HAV IgM uses a two-step sandwich immunoassay with chemiluminescence on the DxI 9000 analyzer. Both assays measure anti-HAV IgM in similar specimen types (serum and plasma) and serve the same clinical purpose, though they employ different platforms and detection methodologies.

Not stated in this summary.

The Elecsys Anti-HAV IgM is substantially equivalent to the Access anti-HAV IgM predicate because both detect the same analyte (anti-HAV IgM), serve the same clinical indication, and are in the same regulatory class (Class II). Performance validation showed 100% negative percent agreement (95% CI 97.0–100%) on 123 pediatric samples, and a spiking study demonstrated equivalent performance between pediatric and adult samples within ≤20% difference, supporting the pediatric claim without reagent changes.