Define the analytical settings

Configure the response data processing logic, the analytical model, and select the suitability test you want to apply.

Before you begin

You have entered your observation data.

About this task

For this use case, you set up the analytical model such that the standard curve is fitted with a 4-parameter logistic fit. As an example for a suitability test system, we use the coefficient of determination test. However, you can add any test suitable for your requirements.

Procedure

To define the analytical settings:

1. In the Content editor, go to Analysis > Response data processing.
2. Under Normalization, normalize the response data to the lowest standard concentration:
   1. Switch from No normalization to by Assay element, and select Standard: STD as the reference.
   2. In the Creatable elements pane, double-click Sequence step, and set the value to 6.
   3. Delete the Adjustment, Transformation, and Replicate averaging nodes, as they are not required for this use case.
3. Under Analytical model, switch from Model: Linear to Model: 4-parameter logistic fit.
4. Go to Suitability tests > Assay suitability tests, and add a test for the coefficient of determination (R²) to your assay:
   1. In the Creatable elements pane, double-click Test: Coefficient of determination (R²).
   2. As the Lower margin, enter 0.99.
5. Save the document.

What to do next

Calculate your assay document.