Hepatitis A virus (Strain HM-175) is cultured in fetal Rhesus monkey kidney cells
The virus is purified using an extraction procedure and inactivated using formaldehyde.
The resulting product contains purified intact HAV virions with minimal cellular debris.
Both IgG and IgM detection in enzyme immunoassays, including polystyrene, latex, nanogold and/or iron bead based assays employing various detection systems (colorimetric, chemiluminescent)
HAV antigen detecting assays
Lymphocyte proliferation assays
Fun Fact: “Hepatitis” is a broad term, but the viruses that cause liver inflammation are morphologically very different. Hepatitis A virus is a much smaller, hardier virus than Hepatitis B or C which are associated with far more serious disease states.
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Each lot of HAV antigen is inactivated using formaldehyde and this inactivation verified using a sensitive tissue culture based infectivity assay.
Each antigen lot is tested for potency using ELISA, and compared to a reference antigen. This ensures the amount of viral protein in each batch is consistent. The total protein concentration reported includes both viral and non-viral proteins, with the ratio dependent on the purity of the antigen.
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