Test: Sum of squares non-linearity

Add one or several tests for the sum of squares non-linearity (also known as sum of squares lack of fit) to your assay. 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 sum of squares non-linearity (from the ANOVA table) has to be less than or equal to the upper margin and greater than or equal to the lower margin set in the test definition.

Note: We do not recommend this test if you have statistical or technical outliers. The number of observations should be equal across all assays, that is, assays for which you use this test and historical assays used in margin development.

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

  • The Standard sample is always included in the calculation.
  • 'Standard only' without simultaneous regression (each Test or Control sample is compared separately to the Standard): No test is computed.
  • 'Test samples only' or 'Control samples only' without simultaneous regression: The test is computed for each Test-vs-Standard or Control-vs-Standard comparison.
  • 'All assay elements' without simultaneous regression: The test is computed for each Test-vs-Standard and for each Control-vs-Standard comparison.
Note: With simultaneous regression (formerly called multiplex assay), all samples are regarded as one single dataset and are tested together (not as individual samples or pairwise comparisons).

Extent of the test

  • Assay element: Runs the test on the data of individual assay elements.
  • Assay: Runs the test on the data of the whole assay.
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/