Suitability testing

Assays are based on curve similarity. Suitability tests allow you to check the validity of calculations every time they are performed. We therefore recommend you set up suitability tests for every quantitative response assay.

Tip: Use the Test system definition document type to define the test system once and reference the documents in the respective assay documents.

To ascertain valid results, we recommend you set up at least one parallelism test or one test for each parameter of the standard curve and one test for each parameter assumed to be similar in the restricted regression model comparing the parameter of Standard sample and Test sample.

Note: If you do not add any tests, you can still calculate relative potencies, but you cannot check their validity.

Test types

You can set up the following types of suitability tests:


Test type	Description
Assay suitability tests	The results of assay suitability test affect the whole assay document rather just individual Standard-vs-Test sample comparisons.
Sample suitability tests	The results of sample suitability test just affect the individual Standard-vs-Test sample comparison for which they are set rather than the whole assay document.

Severity level

The severity level of a test controls how failed tests affect assay results. The highest severity level among failed tests determines how assay results are handled.


Severity level	Impact
Reject	The assay results fail, and no potencies are calculated or reported.
Warning	The assay results fail, but potencies are still calculated and reported.
Information	The assay results pass the test, but an information message is displayed.

Scope

When you add tests that are appropriate for all assay element types, PLA 3.0 runs these tests by default for all assay elements in the assay document. You can restrict the scope of individual tests to have them run only for particular assay element types or for particular assay elements.


Scope	Description
Assay element type	Allows you to select a particular assay element type, that is, Standard sample, Test sample, or Control sample. The test is then run for all assay elements of this particular type, but not for other assay elements in the assay document.
Assay element	Allows you to select a particular assay element, that is, the Standard sample, a particular Test sample, or a particular Control sample or Control line. The test is then run for this particular assay element, but not for other assay elements in the assay document.

Note: Some test types are intended for particular assay element types. The scope of these tests is restricted by default to the intended assay element types. They are not run for assay elements of other types.