M–R

Find reference information on document elements of the Microbial Assays for Antibiotics Package, letters M to R.

Map index to characters

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

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Position factor/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Position factor/

Medium

This section allows you to provide information on the ingredients of the base layer medium and its pH value. 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:

/Cylinder-plate assay (JP 4.02)/Documentation/Base layer/

/Cylinder-plate assay (USP <81>)/Documentation/Base layer/

Medium

This section allows you to provide information on the ingredients of the seed layer medium and its pH value. 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:

/Cylinder-plate assay (JP 4.02)/Documentation/Inoculum/Seed layer/

Name

Enter a name for this column.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Potency data/Column: Section/

/Combination of microbial assays/Potency data/Column: Document reference/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Section/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Section/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/Column: Section/

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

Context:

/Combination of microbial assays/Potency data/Column: Combination group/

/Combination of microbial assays/Potency data/Column: Potency/

/Combination of microbial assays/Potency data/Column: Potency unit/

/Combination of microbial assays/Potency data/Column: Assay test state/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Response value/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Position factor/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Response value/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Position factor/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/Column: Response value/

Name

Enter a name for the Control sample.

Examples:

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

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

This element has the following attributes:

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

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Control/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/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.

This element has the following attributes:

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

Context:

/Combination of microbial assays/

/Cylinder-plate assay (JP 4.02)/

/Cylinder-plate assay (USP <81>)/

/Turbidimetric assay (USP <81>, JP 4.02)/

Name

Enter a name for the Standard sample.

Examples:

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

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

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Assay elements/Standard/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Standard/

Name

Enter a name for the Test sample.

Examples:

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

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

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Assay elements/Test/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Test/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Test/

No adjustment

Performs analysis without response adjustment.

Tip: If you require adjustment 'by Fixed value' or 'by Assay element', select the corresponding option from the drop-down list.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/Adjustment/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/

No dose transformation

Does not perform a logarithmic transformation of the dose values at the beginning of the calculation.

Tip: Select the Logarithmic dose transformation option from the drop-down list if you require.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (USP <81>)/Analysis/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/choice/

No normalization

Performs analysis without response normalization.

Tip: If you require normalization 'by Fixed value' or 'by Assay element', select the corresponding option from the drop-down list.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/Normalization/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/

No transformation

Performs analysis without response transformation.

Tip: If you require Logarithmic, Square, or Square root response transformation, select the corresponding option from the drop-down list.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/Transformation/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Transformation/choice/

Normalization

Normalize your response values by Fixed value or by Assay element. The processing step applies for all assay elements.

Expand the node to add or view information.

Example: Use this feature to divide by the mean absorbance of maximum binding wells.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Response data processing/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/

Normalization

Normalize your response values by Fixed value or by Assay element.

Expand the node to add or view information.

Example: Use this feature to divide by the mean absorbance of maximum binding wells.

Tip: Add a scope element from the Creatable elements pane if you require.

This element has the following attributes:

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

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/

Number of plates

Enter the number of plates to be used for this assay.

Note: This value is distinct from the value for Number of positions which you can set for the 'Plate' column of the Observation data table (Setup > Observation data > Column: Position factor > Number of positions).

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Assay design/

Number of positions

Sets the number of positions available for this position factor.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Position factor/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Position factor/

Number of replicates

Enter a number to specify how many replicates the referencing assay elements (samples) require for each dose step.

This element has the following attributes:

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

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Standard/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Test/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Control/

Observation data

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

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/

/Cylinder-plate assay (USP <81>)/Setup/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/

Observation group ID

Displays the Observation group ID.

Note: Observation group IDs are natural numbers (zero not included).

When you create an assay element, a unique Observation group ID is automatically assigned. 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.
Tip: The Observation group ID is displayed in square brackets in the Observation group column of the Observations editor.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Assay elements/Standard/

/Cylinder-plate assay (JP 4.02)/Setup/Assay elements/Test/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/Reference step group ID/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Test/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Control/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Standard/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Test/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Control/

Observation source

Select how you want to obtain observation data.

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

  • User input: Enter data manually.
  • Aggregation: Specify document references to aggregate data from documents.
  • Import: Not supported.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Potency data/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/

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.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/

/Cylinder-plate assay (JP 4.02)/Documentation/

/Cylinder-plate assay (USP <81>)/Documentation/

/Turbidimetric assay (USP <81>, JP 4.02)/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.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Operator/choice/

/Cylinder-plate assay (JP 4.02)/Documentation/Operator/choice/

/Cylinder-plate assay (USP <81>)/Documentation/Operator/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/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.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Operator/choice/

/Cylinder-plate assay (JP 4.02)/Documentation/Operator/choice/

/Cylinder-plate assay (USP <81>)/Documentation/Operator/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Operator/choice/

Parameter

Select the Parameter to be examined by this test.

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

This element has the following attributes:

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

Context:

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Parameter/property point estimate/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Parameter/property point estimate/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Parameter/property point estimate/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Parameter/property point estimate/

Perform outlier test

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/

pH

Enter the pH of the medium.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Documentation/Inoculum/Seed layer/Medium/

/Cylinder-plate assay (JP 4.02)/Documentation/Base layer/Medium/

/Cylinder-plate assay (JP 4.02)/Documentation/Inoculum/Test organism/Incubation/Incubation medium/

/Cylinder-plate assay (USP <81>)/Documentation/Inoculum/Inoculum medium/

/Cylinder-plate assay (USP <81>)/Documentation/Base layer/Medium/

/Cylinder-plate assay (USP <81>)/Documentation/Inoculum/Test organism/Incubation/Incubation medium/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Inoculum/Inoculum medium/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Inoculum/Test organism/Incubation/Incubation medium/

Plate replicates

Enter a number to specify how many plate replicates this assay requires.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay design/

Potency data

This section allows you to adjust the dataset structure used to summarize Reportable values generated by Combination of microbial assays documents.

Note: Much of the data table is populated from assay documents. These data may not be visible in the Content editor.

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:

/Combination of microbial assays/

Potency of high concentration solution

Enter a decimal number to specify the potency of the high concentration solution. This value serves as step 1 (of 2) of the concentration sequence for both the Standard and the Test sample.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Assay design/Standard solutions/

Potency of low concentration solution

Enter a decimal number to specify the potency of the low concentration solution. This value serves as step 2 (of 2) of the concentration sequence for both the Standard and the Test sample.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Assay design/Standard solutions/

Potency unit

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Assay design/Standard solutions/

Predilution

Enter a decimal number greater than zero to specify the predilution factor to be used for this Test sample. The system multiplies the working concentration of the sample with this factor to determine the absolute concentration of the sample.

Tip: Predilution is set to '1' by default, which is the correct value if no predilution applies.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Test/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Control/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Test/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Control/

Predilution

Enter a decimal number greater than zero to specify the predilution factor to be used for this Test sample. The system multiplies the working concentration of the sample with this factor to determine the absolute concentration of the sample.

Note: The Predilution factor is to include every dilution that occurred prior to the final step of diluting to Potency of high concentration solution.
Tip: Predilution is set to '1' by default, which is the correct value if no predilution applies.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Assay elements/Test/

Property filter

Define a section property filter to be used for data aggregation.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Potency data/Column: Section/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Section/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Section/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/Column: Section/

Property key

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

Note: The key only applies to document aggregation.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Response value/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Position factor/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Response value/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Position factor/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/Column: Response value/

Property key

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

Note: The key only applies to document aggregation.
Note: In the References editor, the Section column displays the Names assigned to assay elements rather than their type such as Standard or Test.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Potency data/Column: Section/Property filter/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Section/Property filter/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Section/Property filter/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/Column: Section/Property filter/

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

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Response value/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Position factor/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Response value/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Position factor/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/Column: Response value/

Rack scope

Select the rack whose response values are to be modified during response data processing.

Tip: If you require 'Assay element type scope' or 'Assay element scope', select the corresponding option from the drop-down list.

This element has the following attributes:

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

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/

Reagent

This section allows you to provide information on a reagent.

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:

/Combination of microbial assays/Documentation/

/Cylinder-plate assay (JP 4.02)/Documentation/

/Cylinder-plate assay (USP <81>)/Documentation/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/

Reagent batch/lot number

Enter the reagent batch or lot number, a combination of numbers, letters, and/or symbols. It identifies a batch (or lot), which allows you to infer the production and distribution history.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Reagent/

/Cylinder-plate assay (JP 4.02)/Documentation/Reagent/

/Cylinder-plate assay (USP <81>)/Documentation/Reagent/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Reagent/

Reagent class

Enter the class of the reagent such as the drug class.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Reagent/

/Cylinder-plate assay (JP 4.02)/Documentation/Reagent/

/Cylinder-plate assay (USP <81>)/Documentation/Reagent/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Reagent/

Reagent description

Enter a description of the reagent.

Tip: You can enter multiline text.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Reagent/

/Cylinder-plate assay (JP 4.02)/Documentation/Reagent/

/Cylinder-plate assay (USP <81>)/Documentation/Reagent/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Reagent/

Reagent identification

Enter information to identify the reagent.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Reagent/

/Cylinder-plate assay (JP 4.02)/Documentation/Reagent/

/Cylinder-plate assay (USP <81>)/Documentation/Reagent/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Reagent/

Reagent name

Enter a name for the reagent.

Tip: You can enter a reference to a reagent document instead. Select the Reagent reference option from the drop-down list.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Reagent/choice/

/Cylinder-plate assay (JP 4.02)/Documentation/Reagent/choice/

/Cylinder-plate assay (USP <81>)/Documentation/Reagent/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Reagent/choice/

Reagent reference

Select a reagent document.

Tip: You can enter a reagent name instead. Select the Reagent name option from the drop-down list.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Reagent/choice/

/Cylinder-plate assay (JP 4.02)/Documentation/Reagent/choice/

/Cylinder-plate assay (USP <81>)/Documentation/Reagent/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Reagent/choice/

Reagent sub-batch/sub-lot number

Enter the reagent sub-batch or sub-lot number, a combination of numbers, letters, and/or symbols. It identifies a sub-batch (or sub-lot), which allows you to infer the production and distribution history.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Reagent/

/Cylinder-plate assay (JP 4.02)/Documentation/Reagent/

/Cylinder-plate assay (USP <81>)/Documentation/Reagent/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Reagent/

Reagent variant

Enter the variant of the reagent.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Reagent/

/Cylinder-plate assay (JP 4.02)/Documentation/Reagent/

/Cylinder-plate assay (USP <81>)/Documentation/Reagent/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Reagent/

Reference concentration

Enter a decimal number greater than zero to specify the working concentration to be used by the calculation for the reference step of the concentration sequence such as for the median test dilution of the standard as defined by USP <81>.

This element has the following attributes:

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

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Standard/Stepwise concentration sequence/choice/

Reference measurements per plate

Enter a number to specify how many reference measurements this assay requires on each plate.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay design/

Reference step group ID

Displays the Observation group ID of the Reference step.

Note: Observation group IDs are natural numbers (zero not included).

When you create an assay element, a unique Observation group ID is automatically assigned. 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.
Tip: The Observation group ID is displayed in square brackets in the Observation group column of the Observations editor.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/

Refence step

This section allows you to define the reference step of the concentration sequence such as the median test dilution of the standard as defined by USP <81>.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/Stepwise concentration sequence/choice/

Replicate averaging

Enable this feature if you want to fit the regression by using the mean of the response values for each sequence step rather than individual response values.

Expand the node to add or view information.

This element has the following attributes:

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

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/

Response data processing

This section allows you to define how your response data is to be processed prior to fitting the regression model. You set up a sequence of response data processing steps.

Expand the node to add or view information.

Two types of response data processing are available:

  • Adjustment
  • Normalization

By default, two response data processing steps are displayed - one of each type. By default, both steps are disabled. Enable the steps you require.

Note: PLA executes response data processing steps in the order they are displayed in this section, from top to bottom. Drag and drop individual steps to change the sequence.
Tip: You can add multiple Adjustment and multiple Normalization steps from the Creatable elements pane.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/

Response data processing

This section allows you to define how your response data is to be processed prior to fitting the regression model. You set up a sequence of response data processing steps.

Expand the node to add or view information.

Three types of response data processing are available:

  • Adjustment
  • Normalization
  • Transformation

By default, three response data processing steps are displayed - one of each type. By default, all three steps are disabled. Enable the steps you require.

Note: PLA executes response data processing steps in the order they are displayed in this section, from top to bottom. Drag and drop individual steps to change the sequence.
Tip: You can add multiple Adjustment and multiple Normalization steps from the Creatable elements pane. But you can only use one Transformation step.

This element has the following attributes:

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

Context:

/Cylinder-plate assay (USP <81>)/Analysis/

Response data processing

This section allows you to define how your response data is to be processed prior to fitting the regression model. You set up a sequence of response data processing steps.

Expand the node to add or view information.

Four types of response data processing are available:

  • Adjustment
  • Normalization
  • Transformation
  • Replicate averaging

By default, four response data processing steps are displayed - one of each type. By default, all four steps are disabled. Enable the steps you require.

Note: PLA executes response data processing steps in the order they are displayed in this section, from top to bottom. Drag and drop individual steps to change the sequence.
Tip: You can add multiple Adjustment and multiple Normalization steps from the Creatable elements pane. But you can only use one Transformation and one Replicate averaging step.
Tip: Add a scope element to individual Adjustment and Normalization steps. This allows you to apply individual steps to specific Assay elements, Assay element types, or Racks.

This element has the following attributes:

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

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/

Role

Enter the role of the operator.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/Operator/

/Cylinder-plate assay (JP 4.02)/Documentation/Operator/

/Cylinder-plate assay (USP <81>)/Documentation/Operator/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Operator/

Row order

Select the sort order you want to apply to the data rows.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Potency data/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/