Severity level of the test

Select the Severity level of the test. The severity level controls how failed tests affect combination results.

The following options are available from the drop-down list:

  • Reject: If the test fails, no combined potencies are reported. For reporting the overall test result, the test is considered 'Rejected'.
  • If the test fails, potencies are reported. For reporting the overall test result, the test is considered 'Failed'.
  • Information: If the test fails, potencies are reported. For reporting the overall test result, the test is considered 'Passed' (info available).

PLA 3.0 determines an overall test result from the severity levels of failed tests, as indicated in the following table:

Overall test result Failed tests of severity level 'Rejected' Failed tests of severity level 'Warning' Failed tests of severity level 'Information'
Passed 0 0 0
Passed (info available) 0 0 ≥1
Failed 0 ≥1 any number
Rejected ≥1 any number any number
Note: In some cases, tests cannot be calculated (for example, if Fieller's formula is needed to calculate test results and computed values are outside the valid range). Tests are then reported as 'NC' and are not used in the calculation of the overall test result.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 1...1 optional none

Context:

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Geometric coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Log potency range (L-value)/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Mean coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Number of invalid assays/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Number of valid assays/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Potency spread (%)/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Sum of weights/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Combined log potency confidence interval width (L-term)/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Combined potency confidence interval/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Combined potency confidence interval (%)/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Combined potency confidence interval range (%)/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Combined potency value/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Homogeneity/

/Combination of independent assay results/Analysis/Suitability tests/alternatives/Test: Signature status/