M–R

Map index to characters

Maps the position index to characters (index 1 is mapped to 'A', index 2 is mapped to 'B', ...).


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

/bioMérieux endotoxin detection assay/Setup/Observation data/Column: Position factor/

Maximal group number

The Maximal group number limits the number of observation groups (assay elements) for which the Observations editor can display data.


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

/bioMérieux endotoxin detection assay/Setup/Observation data/Column: Observation group/

Name

Enter a name for this column.


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

/bioMérieux endotoxin detection assay/Setup/Observation data/Column: Observation group/

Name

Enter a name for the Control sample.

The name is used to report test results, data values, and estimates related to this Control sample. It is also displayed in the Observation group ID column of the Observations editor.

'Assay control', 'Control 3', 'Ctr'

Tip: We recommend to use assay element names that are unique within the assay document. But this is not required. Assay elements are internally identified by their unique Observation group ID.


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

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

Name

Enter a name for this document.

Note: Documents are usually identified by name. We therefore recommend to use unique document names. But this is not required.


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

/bioMérieux endotoxin detection assay/

Name

Enter the name of the instrument used for the assay.


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

/bioMérieux endotoxin detection assay/Documentation/Instrument/

Name

Enter a name for the Standard sample.

The name is used to report test results, data values, and estimates related to this Standard sample. It is also displayed in the Observation group ID column of the Observations editor.

'Standard', 'Std', 'Reference standard'

Tip: We recommend to use assay element names that are unique within the assay document. But this is not required. Assay elements are internally identified by their unique Observation group ID.


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

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

Name

Enter a name for the Test sample.

The name is used to report test results, data values, and estimates related to this Test sample. It is also displayed in the Observation group ID column of the Observations editor.

'Preparation 1', 'Unknown 3', 'Test 2'

Tip: We recommend to use assay element names that are unique within the assay document. But this is not required. Assay elements are internally identified by their unique Observation group ID.


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

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

Number of positions

Sets the number of positions available for this position factor.


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

/bioMérieux endotoxin detection assay/Setup/Observation data/Column: Position factor/

Number of replicates

Enter a number to specify how many replicates the assay element requires for each dose step.


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

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

/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/

Number of steps

Enter a number to specify how many dose steps this sequence requires.


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

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

Observation data

This section allows you to modify the data table that displays observation data in the Observations editor.

Expand the node to add or view information.


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

/bioMérieux endotoxin detection assay/Setup/

Observation group ID

Displays the Observation group ID. Observation group IDs are natural numbers (zero not included).

When you create an assay element, a unique Observation group ID is automatically assigned. In the Observation group column of the Observations editor, the Observation group ID is displayed in square brackets. Since Observation group IDs are required to be unique within assays, we do not recommend to change them manually.

Important: If you manually change the Observation group ID in the definition of an assay element, this does not change the Observation group IDs of observations that may be assigned to this assay element.


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

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

/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/

Operator

This section allows you to provide information on an operator. Expand the node to add or view information.

To add an Operator name or reference: Select the required option from the drop-down list, and enter the name or reference.

To assign a role to the operator: Add the Role element from the Creatable elements pane, and enter the required role.


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

/bioMérieux endotoxin detection assay/Documentation/

Operator name

Enter the name of the operator.

Tip: You can enter a reference to an operator document instead. Select the Operator reference option from the drop-down list.


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

/bioMérieux endotoxin detection assay/Documentation/Operator/choice/

Operator reference

Select an operator document.

Tip: You can enter an operator name instead. Select the Operator name option from the drop-down list.


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

/bioMérieux endotoxin detection assay/Documentation/Operator/choice/

Optimum dRFU value

Enter the value expected to be measured for the concentration of the selected dose step. The value to use depends on the analytical configuration and the test kit and instrument used for the assay.


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

/bioMérieux endotoxin detection assay/Analysis/Gain optimization/

PPC control

This section allows you to provide information on a PPC control sample.

Expand the node to add or view information.


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

/bioMérieux endotoxin detection assay/Setup/Assay elements/

PPC control spike

Enter a value for the endotoxin concentration used to spike the PPC control.


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

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

PPC spike

Enter a value for the endotoxin concentration used to spike the positive product control (PPC) of this sample.


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

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

Property key

Select a Property key to identify the data to be aggregated.

Note: The key only applies to document aggregation.


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

/bioMérieux endotoxin detection assay/Setup/Observation data/Column: Observation group/

Property key

Select the key of the document property you want to use. Only documents in which an element has this property key will be considered for the import.


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

/bioMérieux endotoxin detection assay/Comment/Linked document/Config/Document property filter/

Property key

Select the key of the document property you want to use. The key specifies which data element of the linked document is to be imported into this document.


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

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

Property key

Select the key of the section property you want to use. Only documents in which an element has this property key will be considered for the import.


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

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

Property key

Select the key of the section property you want to use. The key specifies which data element of the linked document is to be imported into this document.


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

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

Property scope

Select a Property scope from the drop-down list.

Note: The scope only applies to document aggregation.

The following options are available to specify the source of the aggregated property:

Document
Section


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

/bioMérieux endotoxin detection assay/Setup/Observation data/Column: Observation group/

Result if test value equals margin

Select how the test system behaves when the observed value is numerically very close or equal to one of the margins set in the test definition.

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

invalidate
pass

Note: If you do not use this option, the default status of the test is passed.


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

/bioMérieux endotoxin detection assay/Analysis/Gain optimization/Test: Maximum CV (%) of the standard responses/

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

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

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

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

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: B parameter (4PL)/

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Inflection point/

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Lower asymptote/

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

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Maximum CV (%) of the standard/

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Maximum CV (%) of samples/

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Maximum CV (%) of PPCs/

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

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Blank concentration/

/bioMérieux endotoxin detection assay/Analysis/Test system/Test: Maximum number of missing standard responses/

Role

Enter the role of the operator.


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

/bioMérieux endotoxin detection assay/Documentation/Operator/

Rounding

Apply a Rounding setting to have the test round values prior to evaluation.

Rounded values are compared to the full-precision margins, critical values, or p-values used in the test.

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 '0 decimal places' option:


Test result	Observed value	Lower margin	Upper margin	Rounded value
Passed because 0.0 ≤ 1.0 ≤ 1.0	0.5113	0.0	1.0	1.0
Passed because -1.0 ≤ -1.0 ≤ 0.0	-0.5113	-1.0	0.0	-1.0
Failed because 1.0 ≥ 0.6	0.5113	0.0	0.6	1.0

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	0...1	optional	none