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Cleaning Validation Glossary


Protein detection method

Defined in United States Pharmacopia <1103> Immunological test methods- Enzyme-Linked Immunosorbent Assay (ELISA) as "a qualitative or quantitative solid-phase immunological method to meassure an analyte following its binding to an immunosorbent surface and its subsequent detection by the use of enzymatic hydrloysis of a reporter substrate, either directly or indirectly". In direct detection the analyte binds with the enzyme, in indirect detection an enzyme-linked antibody binds to the analyte. In laboratory testing ELISA is most commonly used to detect antibodies in the blood of a patient which are produced by the body in response to an antigen.

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