S–Z
Find reference information on document elements of the bioMérieux Endotoxin Detection Assay Package, letters S to Z.
Scaling factor
Enter a value for the scaling factor. The scaling factor is used to determine the optimum instrument gain, taking into account the Optimum dRFU value and the average dRFU of the dose step. The value to use depends on the analytical configuration and the test kit and instrument used for the assay.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:double | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Gain optimization/
Section key
Enter a Section key to restrict the data to the section identified by the key.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:token | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Setup/Observation data/Column: Observation group/
Section key
Enter a Section key to restrict the data to the section identified by the key.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:token | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Comment/Linked document/Config/Section property filter/
Section property filter
Define a filter based on a section property to require referenced documents match this property.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...unbounded | optional | none |
Context:
/bioMérieux endotoxin detection assay/Comment/Linked document/Config/
Section property import
Define the section property you want to import.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...unbounded | optional | none |
Context:
/bioMérieux endotoxin detection assay/Comment/Linked document/Config/
Serial number
Enter the serial number of the instrument used for the assay.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:token | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Documentation/Instrument/
Setup
This section allows you to set up this assay. It provides the following features:
- Assay elements: Details all assay elements, that is, Standard sample, Test samples, Blank control samples, and PPC control samples.
- Observation data: Sets up the data table displayed in the Observations editor. The table is created automatically based on the information you provide on assay elements. But you can delete the Position factor columns.
Expand the node to add or view information.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/
Standard
This section allows you to provide information on the Standard, also referred to as standard sample, standard preparation, or reference standard.
Expand the node to add or view information.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Setup/Assay elements/
Subject
Enter the subject of this comment.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:token | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Comment/
Temperature
Enter the temperature required for incubation.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:token | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Documentation/Incubation/
Template key
Select a template to require referenced documents be generated by this template.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:token | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Comment/Linked document/Config/
Term
Enter a term to define the value of the related property. If you do not enter a term, only the Property key itself is used as a filter, not its value. If you define multiple terms, the system combines them using the logical OR, which means that only one of the terms has to match.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:string | 0...unbounded | optional | none |
Context:
/bioMérieux endotoxin detection assay/Comment/Linked document/Config/Document property filter/
Test
This section allows you to provide information on a Test sample, also referred to as preparation sample or unknown. The activity of the Test sample is interpolated using the regression curve of the Standard sample.
Expand the node to add or view information.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...unbounded | optional | none |
Context:
/bioMérieux endotoxin detection assay/Setup/Assay elements/
Test: B parameter (4PL)
Add a test on the B parameter to your assay. To pass the test, the value of the B parameter of the standard curve has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.
If the test fails, all samples of the assay document are invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Blank concentration
Add a test on the mean calculated concentration of Blank controls to your assay. To pass the test, the value of the calculated concentration has to be lesser than or equal to the upper margin. You can enter the margin manually or derive it from the lowest dose of the Standard sample.
If any of the Blank control elements fails the test, all samples of the assay are invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Blank relative development
Add a tests on the relative development of the blank to your assay. The relative blank development is calculated as the quotient of mean delta relative fluorescence units (dRFU) and mean intial response. To pass the test, the blank development has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.
If any of the Blank control elements fails the test, all samples of the assay are invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Coefficient of determination (|r|)
Add a test on the square root of the coefficient of determination (|r|) to your assay. To pass the test, the |r| value of the regression fit of the standard curve has to be greater than or equal to the lower margin set in the test definition.
If the test fails, all samples of the assay document are invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Inflection point
Add a test on the inflection point to your assay. To pass the test, the value of the inflection point of the standard curve has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.
If the test fails, all samples of the assay document are invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Intercept (linear model)
Add a test on the intercept to your assay. To pass the test, the value of the intercept of the standard curve has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.
If the test fails, all samples of the assay document are invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Lower asymptote
Add a test on the lower asymptote to your assay. To pass the test, the value of the lower asymptote of the standard curve has to be lesser than or equal to the upper margin. You can enter the margin manually or derive it from the lowest dose of the Standard sample.
If the test fails, all samples of the assay document are invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Maximum CV (%) of PPCs
Add a test on the maximal percentual coefficient of variation (CV) on computed endotoxin concentrations for observations of positive product control (PPC) to your assay. The test is evaluated for the PPC of each sample. To pass the test, the coefficient of variation has to be lower than or equal to the upper margin set in the test definition. If the CV of the PPC is calculated as N/A, the test fails.
If the positive product control fails the test, the respective sample is invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Maximum CV (%) of samples
Add a test on the maximal percentual coefficient of variation (CV) on computed endotoxin concentrations for observations of samples to your assay. The test is evaluated for each individual sample. The sample's PPC is ignored. To pass the test, the coefficient of variation has to be lower than or equal to the upper margin set in the test definition. The test also passes if the CV of the sample is calculated as N/A, irrespective of whether all computed endotoxin concentrations fall below the lowest limit of quantification or are deemed as N/A due to other reasons.
If the sample fails the test, it is invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Maximum CV (%) of the standard
Add a test on the maximal percentual coefficient of variation (CV) on computed endotoxin concentrations for the observations of the Standard sample to your assay. The coefficient of variation is calculated for each dilution step individually. To pass the test, the coefficient of variation has to be lower than or equal to the upper margin set in the test definition for each dose step.
If the test fails, all samples of the assay document are invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Maximum CV (%) of the standard responses
Add a test on the maximal percentual coefficient of variation (CV) of the Standard sample responses to your assay. The coefficient of variation is calculated for each dose step individually. To pass the test, the coefficient of variation has to be lower than or equal to the Upper margin set in the test definition for each dose step.
If the CV of the selected step exceeds the maximum CV, the result of the gain optimization is invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Gain optimization/
Test: Maximum number of missing standard responses
Add a test on the maximum number of missing standard responses to your assay. The number is based on the difference between the final response and the initial response of the standard sample. A response is considered missing if any of the following conditions are met:
- The respective observation is flagged as technical outlier.
- The response of the respective observation is missing or invalid.
To pass the test, the number of missing standard responses has to be lower than or equal to the upper margin set in the test definition.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: PPC recovery rate
Add a test on the recovery of the positive product control associated with Test samples to your assay. To pass the test, the recovery of the PPC has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.
If the test fails, the respective Test sample is invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Slope (linear model)
Add a test on the slope to your assay. To pass the test, the value of the slope of the standard curve has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.
If the test fails, all samples of the assay document are invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test: Upper asymptote
Add a test on the upper asymptote to your assay. To pass the test, the value of the upper asymptote of the standard curve has to be greater than or equal to the lower margin set in the test definition. You can enter the margin manually or derive it from the highest dose of the Standard sample.
If the test fails, all samples of the assay document are invalidated.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/
Test system
This section allows you to define the statistical tests you require to prove the validity of your endotoxin assay. Some tests invalidate all samples of the assay document, while others only invalidate individual samples. The default margins of most tests are defined according to the EndoLISA® and ENDOZYME® II Go specifications. You can adapt them as you require.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Node | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/
Text
Enter your comment.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:string | 0...unbounded | optional | none |
Context:
/bioMérieux endotoxin detection assay/Comment/
Time of final measurement
Enter the date and time of the final measurement after incubation.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:dateTime | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Documentation/
Time of initial measurement
Enter the date and time of the initial measurement before incubation.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:dateTime | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Documentation/
Update mode
Select how you want to update data provided by the referenced document.
The following options are available from the drop-down list:
- Auto: Have data updated automatically.
- Manual: Update data manually from the References dialog.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:token | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Documentation/Operator/choice/Operator reference/Config/
Upper margin
Enter the Upper margin of the test as decimal number. To pass the test, the observed value must be less than or equal to the upper margin.
Please consult the help page of the test for additional information.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:double | 0...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Slope (linear model)/
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: B parameter (4PL)/
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Inflection point/
| Data type | Multiplicity | Usage | Default value |
| xs:double | 1...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Intercept (linear model)/
Upper margin
Enter the Upper margin of the test as natural number (zero included). To pass the test, the observed value must be less than or equal to the upper margin.
Please consult the help page of the test for additional information.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:nonNegativeInteger | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Maximum number of missing standard responses/
Upper margin (based on lowest dose response)
Select how you want to define the upper margin of the test. To pass the test, the observed value must be less than or equal to the upper margin.
The following options are available from the drop-down list:
- Upper margin (fixed): Allows you to enter a decimal number to set the lower margin manually.
- Upper margin (based on lowest dose response): The upper margin is derived from the lowest dose of the Standard sample.
Please consult the help page of the test for additional information.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Empty | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Lower asymptote/choice/
Upper margin (based on lowest dose standard)
Select how you want to define the upper margin of the test. To pass the test, the observed value must be less than or equal to the upper margin.
The following options are available from the drop-down list:
- Upper margin (fixed): Allows you to enter a decimal number to set the Upper margin manually.
- Upper margin (based on lowest dose standard): The upper margin is derived from the lowest nominal dose of the Standard sample.
Please consult the help page of the test for additional information.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| Empty | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Blank concentration/choice/
Upper margin (fixed)
Select how you want to define the upper margin of the test. To pass the test, the observed value must be less than or equal to the upper margin.
The following options are available from the drop-down list:
- Upper margin (fixed): Allows you to enter a decimal number to set the lower margin manually.
- Upper margin (based on lowest dose response): The upper margin is derived from the lowest dose of the Standard sample.
Please consult the help page of the test for additional information.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:double | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Lower asymptote/choice/
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Blank concentration/choice/
Upper margin (%)
Enter the Upper margin of the test as percentual decimal number. To pass the test, the observed value must be less than or equal to the Upper margin.
Please consult the help page of the test for additional information.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:double | 1...1 | optional | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Gain optimization/Test: Maximum CV (%) of the standard responses/
Upper margin (%)
Enter the Upper margin of the test as percentual decimal number. To pass the test, the observed value must be less than or equal to the upper margin.
Please consult the help page of the test for additional information.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:double | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: PPC recovery rate/
/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Blank relative development/
Used standard step
Select the dose step of the Standard sample to be used as reference for determining the optimum instrument gain. Commonly, the dose step of the Standard sample with a nominal concentration of about 0.5 EU/ml is used for determining the optimum instrument gain.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:positiveInteger | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/Gain optimization/
Wavelength
Enter the wavelength used for the measurement.
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:token | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Documentation/Excitation/
/bioMérieux endotoxin detection assay/Documentation/Emission/
Weight
Select the weighting method to be used in the model fit. The method you select is used to weigh the dose steps according to the variance of their responses.
The following options are available from the drop-down list:
- 1/y
- 1/y²
This element has the following attributes:
| Data type | Multiplicity | Usage | Default value |
| xs:token | 1...1 | required | none |
Context:
/bioMérieux endotoxin detection assay/Analysis/choice/4-parameter logistic model/