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Analyte Specific Reagent (ASR) , Biodesign International
September 2005
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Biodesign offers cGMP-manufactured mouse IgG as an ASR reagent for use in diagnostic assay development. This product pertains to the FDA's recently issued draft guideline on a serological assay for Hepatitis A, in its effort to address immunoassay interference ob-served in diagnostic assay kits. Specific guidance has been issued to include assay performance data on heterophilic antibodies during assay development. Heterophilic antibodies are human anti-animal antibodies that are present in a small percentage of normal individuals. The most common heterophilic antibody is human anti-mouse antibody (HAMA) which interferes with diagnostic assays using monoclonal antibodies. This product is available by special order only.
 
Biodesign International
888.530.0140

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