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This validation describes the general assay criteria which are determined routinely: sensitivity, measuring range, parallelism, recovery and intra assay variation coefficient. Cross reactions to similar substances are determined only if they occur. A reliable value for the interassay variation coefficient can only be obtained after completion of the assay development by carrying through the test with a large number of samples.
Tips for carrying out enzyme-immune-assays
This validation means the experimental proof of known biological reactions by an already developed assay. For example in a stimulation experiment in vivo on animals or in cell culture media. We can barely carry through those examinations, because we neither practice animal husbandry nor cell culture.
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