E–L

Edit mode

Select the Edit mode.

The following options are available:

Select: Allows you to select an existing document.
Create: Allows you both to select an existing document and to create a new document.


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

/bioMérieux endotoxin detection assay/Comment/Linked document/Config/

Emission

This documentation section allows you to provide information on the emission. Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/bioMérieux endotoxin detection assay/Documentation/

Endotoxin limit

Enter a value for endotoxin limit to be used as the threshold for the Test sample. The sample is considered accepted if it is valid and its endotoxin level lies below the threshold.


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

/bioMérieux endotoxin detection assay/Setup/Assay elements/Test/

Excitation

This documentation section allows you to provide information on the excitation. Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/bioMérieux endotoxin detection assay/Documentation/

Exclude from analysis / invalid assay element

Select the 'yes' option from the drop-down list to exclude this assay element from analysis. Or select 'no' to include it.

Note: If you exclude an assay element from analysis, the related assay, data, and settings (such as test definitions for the assay element) are completely ignored. And the assay element is not included in reports.


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

/bioMérieux endotoxin detection assay/Setup/Assay elements/Test/

/bioMérieux endotoxin detection assay/Setup/Assay elements/Blank control/

/bioMérieux endotoxin detection assay/Setup/Assay elements/PPC control/

Field

Enter the name of the property you want to import.


Data type	Multiplicity	Usage	Default value
xs:Name	1...1	required	none

/bioMérieux endotoxin detection assay/Comment/Linked document/Config/Section property import/

Final activity rounding

Apply a rounding setting to have the final activity values rounded prior to evaluation against the endotoxin limit.

Rounded values are compared to the full-precision endotoxin limit.

The following options are available:

No rounding
x decimal places (where x is an integer from 0 to 5)

Note: The rounding method 'half away from zero' is used.

Rounding examples for the '2 decimal places' option:


Endotoxin status	Final activity (before rounding)	Final activity (after rouding)	Endotoxin limit
Passed because 0.04 < 0.05	0.0425	0.04	0.05
Failed because 0.05 ≥ 0.05	0.04995	0.05	0.05

Note: You may need this feature to follow protocol procedures or company regulations. We do not recommend to use rounding for test evaluation.


Data type	Multiplicity	Usage	Default value
xs:string	1...1	required	none

/bioMérieux endotoxin detection assay/Analysis/

Folder key

Select a folder to require referenced documents be elements of this folder.

Tip: Add an Allow subfolders element and select the 'true' option from its drop-down list to require referenced documents be elements of the specified folder or one of its subfolders.


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

/bioMérieux endotoxin detection assay/Comment/Linked document/Config/

Gain

Enter the gain used for the measurement.


Data type	Multiplicity	Usage	Default value
xs:double	1...1	required	none

/bioMérieux endotoxin detection assay/Documentation/Instrument/

Gain optimization

This section allows you to define a gain optimization routine. Select the dose step of the Standard sample to be used as reference for determining the optimum instrument gain. To determine the optimum instrument gain, the average dRFU of the dose step you select is compared to the corresponding Optimum dRFU value.

Expand the node to add or view information.

Tip: Remove this element if you do not require an optimization of instrument gain.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/bioMérieux endotoxin detection assay/Analysis/

Generator key

Enter a document key to require referenced documents be generated by a document that matches the key.


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

/bioMérieux endotoxin detection assay/Comment/Linked document/Config/

Geometric sequence

Allows you to define an n-fold geometric sequence. That is, the dilution sequence has 'n' steps, and each of the 'n - 1' terms after the first is found by multiplying the previous by a fixed number.

The dose value for step number 'j' of an n-fold sequence is given by:

(Initial working concentration) \cdot {(Base)}^{(1 - j)}


Initial working concentration	Base	1st step	2nd step	3rd step	n-th step
		= Initial working concentration	= Initial working concentration / Base	= Initial working concentration / Base^2	= Initial working concentration / Base^n
5	10	5.0	0.5	0.05	5* 10^(1-n)
8	2	8.0	4.0	2.0	8* 2^(1-n)
1	0.5	1.0	2.0	4.0	1*(1/2)^(1-n)
5	3	5.0	1.67	0.56	5* 3^(1-n)


Data type	Multiplicity	Usage	Default value
Node	1...1	required	none

/bioMérieux endotoxin detection assay/Setup/Assay elements/Standard/

Incubation

This documentation section allows you to provide information on the final incubation of the completed plate. Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/bioMérieux endotoxin detection assay/Documentation/

Initial working concentration

Enter a number to specify the Initial working concentration of this sequence.

Note: The number you enter must be a non-negative decimal.


Data type	Multiplicity	Usage	Default value
xs:double	1...1	required	none

/bioMérieux endotoxin detection assay/Setup/Assay elements/Standard/Geometric sequence/

Instrument

This documentation section allows you to provide information on the instrument. Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/bioMérieux endotoxin detection assay/Documentation/

Linear model

Uses the linear regression model. The model is defined by the following equation:

log(net dRFU) = m \cdot log (Dose) + n

Tip: Select the 4-parameter logistic model option from the drop-down list if you want to use a 4-parameter logistic fit model.


Data type	Multiplicity	Usage	Default value
Node	1...1	required	none

/bioMérieux endotoxin detection assay/Analysis/choice/

Linked document

Select a document.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/bioMérieux endotoxin detection assay/Comment/

Lower margin

Enter the Lower margin of the test as decimal number. To pass the test, the observed value must be greater than or equal to the lower margin.

Please consult the help page of the test for additional information.


Data type	Multiplicity	Usage	Default value
xs:double	1...1	required	none

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Coefficient of determination (|r|)/

Lower margin

Enter the Lower margin of the test as decimal number. To pass the test, the observed value must be greater than or equal to the lower margin.

Note: The system permits equal values for upper and lower margin.

Please consult the help page of the test for additional information.


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

/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

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Intercept (linear model)/

Lower margin (based on highest dose response)

Select how you want to define the lower margin of the test. To pass the test, the observed value must be greater than or equal to the lower margin.

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

Lower margin (fixed): Allows you to enter a decimal number to set the lower margin manually.
Lower margin (based on highest dose response): The lower margin is derived from the highest dose of the Standard sample.

Please consult the help page of the test for additional information.


Data type	Multiplicity	Usage	Default value
Empty	1...1	required	none

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Upper asymptote/choice/

Lower margin (fixed)

Select how you want to define the lower margin of the test. To pass the test, the observed value must be greater than or equal to the lower margin.

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

Lower margin (fixed): Allows you to enter a decimal number to set the lower margin manually.
Lower margin (based on highest dose response): The lower margin is derived from the highest dose of the Standard sample.

Please consult the help page of the test for additional information.


Data type	Multiplicity	Usage	Default value
xs:double	1...1	required	none

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Upper asymptote/choice/

Lower margin (%)

Enter the Lower margin of the test as percentual decimal number. To pass the test, the observed value must be greater than or equal to the lower margin.

Note: The system permits equal values for upper and lower margin.

Please consult the help page of the test for additional information.


Data type	Multiplicity	Usage	Default value
xs:double	1...1	required	none

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: PPC recovery rate/

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Blank relative development/

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Edit mode

This element has the following attributes:

Emission

This element has the following attributes:

Endotoxin limit

This element has the following attributes:

Excitation

This element has the following attributes:

Exclude from analysis / invalid assay element

This element has the following attributes:

Field

This element has the following attributes:

Final activity rounding

This element has the following attributes:

Folder key

This element has the following attributes:

Gain

This element has the following attributes:

Gain optimization

This element has the following attributes:

Generator key

This element has the following attributes:

Geometric sequence

This element has the following attributes:

Incubation

This element has the following attributes:

Initial working concentration

This element has the following attributes:

Instrument

This element has the following attributes:

Linear model

This element has the following attributes:

Linked document

This element has the following attributes:

Lower margin

This element has the following attributes:

Lower margin

This element has the following attributes:

Lower margin (based on highest dose response)

This element has the following attributes:

Lower margin (fixed)

This element has the following attributes:

Lower margin (%)

This element has the following attributes: