Test: Maximal number of outliers

Add one or several tests for the maximal number of outliers to your assay. The test counts technical outliers, statistical outliers, and missing values. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the number of technical and statistical outliers and missing values has to be less than or equal to the upper margin set in the test definition.

Tip: Use the scope and extent settings to select the assay elements for which the maximal number of outliers is to be calculated.

Supported models

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Scope of the test

  • Standard only: Runs the test for the Standard sample.
  • Test samples only: Runs the test for every Test sample.
  • Control samples only: Runs the test for every Control sample.
  • Control lines only: Runs the test for every Control line.
  • All assay elements: Runs the test for every assay element.

Extent of the test

  • Assay element: Runs the test on the data of individual assay elements. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for each individual Test sample.
  • Assay (without simultaneous regression): Runs the test on the data of individual Test-vs-Standard and Control-vs-Standard comparisons. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for each individual Test-vs-Standard comparison. The observations of each sample pair are regarded as a dataset for which the number of outliers is determined.
  • Assay (simultaneous regression): Runs the test on the data of the whole assay. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for the whole assay. The observations of all samples are regarded as one single dataset for which the number of outliers is determined.
  • Sequence step: Runs the test on the data of individual sequence steps. To pass the test, the number of outliers of each sequence step has to be less than or equal to the Upper margin. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for each individual sequence step of the Test samples.
Note: If you set the Extent of the test to 'Assay', the test is either evaluated for each Standard-vs-Test sample comparison or the whole assay in the case of simultaneous regression. Therefore, also setting the Assay element type scope to 'Standard only' is not supported.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/