A–D

Find reference information on document elements of the bioMérieux Endotoxin Detection Assay Package, letters A to D.

4-parameter logistic model

Uses the 4-parameter logistic-fit regression model. The model is defined by the following equation:

dRFU = ( A - D ) 1 + Dose C B + D

Tip: Select the Linear model option from the drop-down list if you want to use a linear model.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Analysis/choice/

Allow subfolders

Select the 'true' option from the drop-down list to require referenced documents be elements of the specified folder or one of its subfolders. Otherwise, subfolders are excluded.

Note: The Allow subfolders setting only applies if you also specify a folder in the Folder key element.

This element has the following attributes:

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

Context:

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

Analysis

This section allows you to specify the regression model, Coefficient of variation mode, a gain optimization routine, and statistical tests to be used in calculations.

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/

Assay elements

This section allows you to define all assay elements.

bioMérieux endotoxin detection assay documents contain the following types of assay elements:

  • Standard: To provide the reference standard.
  • Test: To determine the endotoxin concentration.
  • Blank control: To define the control adjustment for the linear model.
  • PPC control: To define the positive product control control. This assay element does not affect the assay validity.

Expand the node to add or view information. Add assay elements from the context menu or Creatable elements pane 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/Setup/

Author

Automatically inserts the user name of the current user when the Author element is created. You can enter a different name.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Comment/

Bandwidth

Enter the bandwidth 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/

Base

Enter a number to specify the Base of this sequence.

Note: The number you enter must be a positive decimal.

This element has the following attributes:

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

Context:

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

Batch/lot number

Enter the assay kit 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:

/bioMérieux endotoxin detection assay/Documentation/

bioMérieux endotoxin detection assay

bioMérieux endotoxin detection assay documents provide the features you need to perform endotoxin testing based on recombinant factor C (rFC), a synthetic alternative to naturally sourced reagents derived from horseshoe crabs, as offered by bioMérieux.

Navigate through the properties to select or enter settings you require for this bioMérieux endotoxin detection assay:

1. Expand the node to add or view information.

  • The second level of the document structure displays the Name and Date of the document.
  • It also provides access to the Documentation, Setup, and Analysis sections.

2. Double-click the Comment element in the Creatable elements pane to add it to the document.

Note: To delete an element from the document, right-click the element in the document structure and select the Delete element option from the pop-up menu.

This element has the following attributes:

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

Context:

Top level

Blank control

This section allows you to provide information on a Blank control 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/

Coefficient of variation mode

Select the type of standard deviation to be used when calculating the coefficient of variation.

The following options are available:

  • By sample: Calculate the coefficient of variation using sample standard deviation.
  • By population: Calculate the coefficient of variation using population standard deviation.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Analysis/

Column: Final response value

Holds the final response values of individual observations after incubation.

You can acquire the values using specific import modules, copy and paste them from an external application such as a spreadsheet, or type them in manually.

This data table column is named Final response by default.

Note: The data type of this column is nonnegative double-precision floating-point number.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Setup/Observation data/

Column: Initial response value

Holds the initial response values of individual observations before incubation.

You can acquire the values using specific import modules, copy and paste them from an external application such as a spreadsheet, or type them in manually.

This data table column is named Initial response by default.

Note: The data type of this column is nonnegative double-precision floating-point number.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Setup/Observation data/

Column: Observation group

Links individual observations (measurements, data table rows) to their assay element (sample).

Each observation group comprises the observations of a single assay element (sample). The unique ID of the observation group is set in the definition of the assay element.

This data table column is named Observation group ID by default. It displays both the observation group ID and the assay element name for each observation.

Note: The Maximal group number limits the number of observation groups (assay elements) for which the Observations editor can display data. If your assay document has more assay elements, you require more observation groups and must change the Maximal group number accordingly.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Setup/Observation data/

Column key

Displays the Column key. The key is required to define a sort order based on this column.

Note: The key is used to identify the column, for example, in data acquisition.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Setup/Observation data/Column: Initial response value/

Column key

Enter a key for this column.

Note: The key is required to define a sort order based on this column.

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: Position factor/

Column key

Displays the Column key.

Note: You cannot change the key of this column.
Note: The key is required to define a sort order based on this column.

This element has the following attributes:

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

Context:

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

Column: Position factor

Define up to two columns that allow you to associate each observation with the position where the observation occurred.

If you work with a microplate, for example, define two position factor columns to specify the microplate row and column of each observation.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...2 optional none

Context:

/bioMérieux endotoxin detection assay/Setup/Observation data/

Column: Positive product control flag

Provides a column to flag positive product control observations of a sample in the data table.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Setup/Observation data/

Column: Sequence step

Links individual observations (measurements, data table rows) to their dilution sequence step.

This data table column is named Sequence step by default. It displays both the sequence step number and the dose value for each observation.

Note: The total number of steps and replicates of an assay element (Standard, Test, Blank control, or PPC control) is defined in the settings of the respective element.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Setup/Observation data/

Column: Technical-outlier flag

Provides a column to flag technical outliers in the data table.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Setup/Observation data/

Comment

Enter a comment, or add a reference to a comment document.

Tip: You can add several Comment elements. And to each Comment element, you can add a Subject element, Text elements, and Linked document elements.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/

Config

Configure the document reference. Expand the node to add or view information.

Add elements to change the document selection and generation process. You can restrict the selected document to a particular folder, for example.

The following child elements are available:

  • Update mode
  • Template key
  • Folder key
  • Allow subfolders
  • Generator key
  • Document mode

This element has the following attributes:

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

Context:

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

Config

Set up the details of the linked document and the data you want to import.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Comment/Linked document/

Control for adjustment

Select the Blank control sample to be used for calculating the net dRFU. To obtain the net dRFU, the mean dRFU of the Blank control sample is subtracted from the dRFUs of the Standard and Test samples.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Analysis/choice/Linear model/

Current gain

Select the gain used for the measurement. This is the gain you entered for the instrument in the documentation section of this assay document.

Tip: To create an instrument, right-click the element in the document structure and select the Create target for current gain... option from the context menu.

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/

Date

Automatically inserts the current date and time when the Date element is created. You can enter a different date and time.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/Comment/

Date

Automatically inserts the current date and time when the document is created. You can enter a different date and time.

Tip: Use the date for sorting in aggregation documents.

This element has the following attributes:

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

Context:

/bioMérieux endotoxin detection assay/

Dilution factor

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

Tip: Dilution factor 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:

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

Document mode

Select a Document mode from the drop-down list to require referenced documents match this mode.

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/

Document property filter

Define a filter based on a document 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/

Document property import

Define the document 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/

Document type

Select the document type of the documents to be referenced.

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/

Documentation

This section allows you to provide information on an operator, the incubation procedure, and the instrument gain. 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:

/bioMérieux endotoxin detection assay/

Duration

Enter the time 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/