Assay elements

In PLA 3.0, assay elements are the building blocks of assay documents.

Quantitative response assay documents require at least one Standard sample (reference) and one Test sample or Control sample to calculate potency. They can contain up to four different assay element types.

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.

Test sample

Provides the data to be evaluated 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).

Test samples are optional. But every assay document must have at least one Test or Control sample. You can add as many Test samples as you require.

Control sample

Provides the basis of 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).

Control samples are optional. But every assay document must have at least one Test or Control sample. You can add as many Control samples as you require.

Control line

Provides an undiluted control value which is usually displayed as a line in an assay chart. Use Control lines for response adjustment, such as blank deduction, positive control, and negative control, or as basis for restricting an asymptote in full curve fits (3-parameter fits).

Control lines are optional. You can add as many Control lines as you like.