New assay documents of the Microbial Assays for Antibiotics Package do not contain any
statistical tests. Add the assay suitability and sample suitability tests you
require.
In this example, we use a Turbidimetric assay (USP <81>/JP 4.02) document to show how you define a
test system.
Before you begin
Create a Turbidimetric assay (USP <81>/JP 4.02) document.
About this task
To comply with USP <81>, you can set up the following assay suitability
and sample suitability tests:
Combined standard deviation of the standard
Coefficient of determination (R²)
Relative potency (percentage of reference concentration)
Procedure
To set up your assay suitability tests:
In the Content editor, go to Analysis > Test system > Assay suitability tests.
Use the Creatable elements pane to add a
Test: Combined standard deviation of the standard and
a Test: Coefficient of determination(R2) element.
Result: PLA 3.0 adds both tests to the Assay
suitability tests section.
Go to Test: Combined standard deviation of the standard
and set up the test as follows:
Set the limit for the combined standard deviation of the standard as
the Upper margin. Enter
.1.
Leave the rest of the settings unchanged.
Go to Test: Coefficient of determination(R2) and set up
the test as follows:.
Set the limit for the coefficient of determination as the
Lower margin. Enter
.9.
Leave the rest of the settings unchanged.
To set up your sample suitability tests:
Go to Sample suitability tests.
Use the Creatable elements pane to add a
Test: Relative potency (percentage of reference
concentration) element.
Result: PLA 3.0 adds the test to the Sample
suitability tests section.
Go to Test: Relative potency (percentage of reference
concentration) and set up the test as follows:
Set the upper limit for the relative potency of test samples compared
to the reference concentration of the standard as the Upper
margin. Enter 125.
Set the lower limit for the relative potency of test samples compared
to the reference concentration of the standard as the Lower
margin. Enter 80.
Makes sure that the Assay element type scope is
set to Test samples only (default).
Save the document.
Result
Your test system should now look like this:Figure 1. Test system section of a Turbidimetric assay (USP <81>/JP 4.02) document displayed in the
Content editor