Severity level of the test

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

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

Reject: If the test fails, no 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: If tests cannot be calculated and return 'not calculated' (NC) results (for example, if Fieller's formula is needed to calculate test results and computed values are outside the valid range), the behavior of the test system depends on your settings in Test exception handling. Please consult the help pages on Test exception handling for additional information.

* The term 'assay' here refers to calculations for individual sample pairs (Test sample compared to Standard) unless simultaneous regression (formerly called multiplex assay) is used. If a test is set up as an Assay suitability test, it also counts for calculations of the overall test results of other sample pairs in the assay document.


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

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/F-test (hypothesis test)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Equivalence test: Parameter estimate/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Equivalence test: Difference of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Equivalence test: Ratio of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Equivalence test: Scaled parameter range/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Point estimate test: Parameter estimate/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Point estimate test: Difference of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Point estimate test: Ratio of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Normalized difference of asymptotes/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Sum of squares regression/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Sum of squares non-parallelism/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Sum of squares non-linearity/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Ratio sum of squares non-linearity / sum of squares regression/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Potency value/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Potency confidence interval/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Log potency range (L-value)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Potency of intermediate dilution/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Potency confidence interval (%)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Potency range (%)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Weight (W)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Maximal number of outliers/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Maximal sequence step CV (%)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Minimal R²/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Relative LOF error (%)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Response value range/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/Test: Root mean square error (RMSE)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/F-test (hypothesis test)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Equivalence test: Parameter estimate/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Equivalence test: Difference of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Equivalence test: Ratio of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Equivalence test: Scaled parameter range/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Point estimate test: Parameter estimate/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Point estimate test: Difference of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Point estimate test: Ratio of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Normalized difference of asymptotes/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Sum of squares regression/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Sum of squares non-parallelism/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Sum of squares non-linearity/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Ratio sum of squares non-linearity / sum of squares regression/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Potency value/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Potency confidence interval/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Log potency range (L-value)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Potency of intermediate dilution/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Potency confidence interval (%)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Potency range (%)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Weight (W)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Maximal number of outliers/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Maximal sequence step CV (%)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Minimal R²/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Relative LOF error (%)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Response value range/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/Test: Root mean square error (RMSE)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/F-test (hypothesis test)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Equivalence test: Parameter estimate/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Equivalence test: Difference of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Equivalence test: Ratio of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Equivalence test: Scaled parameter range/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Point estimate test: Parameter estimate/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Point estimate test: Difference of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Point estimate test: Ratio of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Normalized difference of asymptotes/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Sum of squares regression/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Sum of squares non-parallelism/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Sum of squares non-linearity/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Ratio sum of squares non-linearity / sum of squares regression/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Potency value/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Potency confidence interval/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Log potency range (L-value)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Potency of intermediate dilution/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Potency confidence interval (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Potency range (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Weight (W)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Maximal number of outliers/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Maximal sequence step CV (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Minimal R²/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Relative LOF error (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Response value range/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/Test: Root mean square error (RMSE)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/F-test (hypothesis test)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Equivalence test: Parameter estimate/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Equivalence test: Difference of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Equivalence test: Ratio of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Equivalence test: Scaled parameter range/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Point estimate test: Parameter estimate/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Point estimate test: Difference of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Point estimate test: Ratio of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Normalized difference of asymptotes/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Sum of squares regression/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Sum of squares non-parallelism/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Sum of squares non-linearity/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Ratio sum of squares non-linearity / sum of squares regression/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Potency value/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Potency confidence interval/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Log potency range (L-value)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Potency of intermediate dilution/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Potency confidence interval (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Potency range (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Weight (W)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Maximal number of outliers/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Maximal sequence step CV (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Minimal R²/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Relative LOF error (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Response value range/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/Test: Root mean square error (RMSE)/


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Quantitative response assay/Analysis/Suitability tests/Document suitability tests/Signature state/

/Test system definition (Quantitative response assay)/Suitability tests/Document suitability tests/Signature state/

/Quantitative response assay/Analysis/Suitability tests/Document suitability tests/Test on user variable/

/Test system definition (Quantitative response assay)/Suitability tests/Document suitability tests/Test on user variable/

Severity level of the test

This element has the following attributes: