Acceptance Tests

You can easily define the test system per assay. Several tests are available in PLA 3.0. When setting up your bioassay, simply add a test to the assay definitions.

Test Type

  • Assay Suitability Tests have the power to fail an entire assay.
  • Sample Suitability Tests may fail a single assay.

Test Scope

Every defined test has a scope defining its applicability to the different assay elements:

  • All Assay Elements
  • Standard Samples
  • Test Samples
  • Control Samples
  • Control Lines

Test Severity

Every test is assigned a severity level defining its impact on the overall test state:

  • Reject - a failure of the test leads to a rejection of the assay. No potency is calculated.
  • Warning - a failure raises a warning. The assay is failed, but a potency is calculated.
  • Information - a failure just brings up an information message. The assay is accepted.

Available Tests in PLA 3.0

The available tests fall into three groups:

We describe hypothesis tests and equivalence tests on a separate page. In addition to them the following tests are currently available:

  • Max. number of outliers
  • Response value range
  • Relative Potency
  • Relative Potency Confidence Interval
  • Relative Potency Range (%)
  • Assay Weight W
  • Sum of Square Non-Linearity

PLA 3.0 offers a very comprehensive selection of tests to suit all your statistical needs. Still unsure, if these tests work for your application? Ask our support team to find out!