Set up the assay elements

Set up the assay elements required for this use case, that is, elements for the Standard, Test, and Blank control samples.

Before you begin

You have created a bioMérieux endotoxin detection assay document.

About this task

For this use case, you work with a subset of the samples supported by the GOPLATE™ layout, that is, one Standard sample, nine Test samples, and one Blank control sample.

Procedure

To add the assay elements required for this use case:
  1. In the Content editor, go to Setup > Assay elements.
  2. Created from scratch, bioMérieux endotoxin detection assay documents have one Test sample. To set up nine Test samples, add eight extra Test elements:
    1. In the Creatable elements pane, right-click Test, and then select Create multiple elements from the context menu.
    2. In the Create multiple elements dialog, change the value of Number of elements to create to 8.
    3. To add the elements, select OK.
    Result: Your assay now has nine Test samples.
  3. This use case requires a Blank control sample. Therefore, you have to add one Blank control element: In the Creatable elements pane, double-click Blank control.
    Result: Your assay now has a Blank control sample.
To set up the Standard sample:
  1. Expand the Standard element.
  2. Change the geometric sequence from a four-step to a three-step sequence:
    1. Expand the Geometric sequence node.
    2. As the Number of steps, enter 3.
To set up the Test samples:
  1. Each water grade is tested by three Test samples, that is, purified water (PureWx), Water for Injections (WFIx), and endotoxin-free water for validation (ValWx). Change the names of your Test samples such that they reflect the respective water grade:
    1. Expand the Test element you want to rename.
    2. As the value of the Name element, enter the new name according to the following table:
      Default name Change to

      TST1, TST2, TST3

      PureW1, PureW2, PureW3

      TST4, TST5, TST6

      WIF1, WIF2, WIF3

      TST7, TST8, TST9

      ValW1, ValW2, ValW3
  2. For all Test samples, set the endotoxin limit to 0,25 EU/ml.
    1. Expand the PureW1 element.
    2. As the Endotoxin limit, enter 0.25
    3. Repeat the steps for all Test elements.
  3. For the validation Test samples, set the dilution to 1:2:
    1. Expand the ValW1 element.
    2. As the Dilution factor, enter 2.
    3. Repeat the steps for the ValW2 and ValW3 elements.
  4. Rename the Blank control element to BLK.
  5. Save the document.

What to do next

Define the analytical settings.