Assay elements
Dichotomous assay documents require at least one Standard sample (reference) and one Test or Control sample to calculate the potency. They usually involve a range of assay elements with data measured at different dilutions (or concentrations) of the active ingredient.
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The Standard sample provides the reference standard of the assay document. You calculate relative potencies in comparison to this assay element. A Standard sample consists of a series of measurements at various dilutions (or concentrations). Every assay document must have exactly one Standard sample element.
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The Test sample provides the data you want to evaluate by the assay document. You calculate the relative potencies of these assay elements. A Test sample consists of a series of measurements at various dilutions (or concentrations). The Test sample element is optional. But every assay document must have at least one Test or Control sample. You can add as many Test samples as you like.
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The Control sample provides the basis for assay acceptance tests. Control samples are Test samples that are 'well known.' A Control sample consists of a series of measurements at various dilutions (or concentrations). The Control sample element is optional. But every assay document must have at least one Control or Test sample. You can add as many Control samples as you like.