Test sample elements

The Test sample elements of CSV reports provide result data of the Test samples together with one PPC per sample.

Example

See the following abstract from an example report with the Test sample elements (shortened):

Report example

For a detailed description of this type of assay element, see the Assay elements topic.

Available elements

The following table describes the Test sample elements. For each Test sample, there is a subsection ('SPL1,' 'SPL2'). Values for the associated PPC are marked as 'PPC1,' 'PPC2,' etc. in the first column respectively.

Key Description Entry in Validity column Usage

Name

Name of the Test sample

no

mandatory

Endotoxin limit

Endotoxin limit to be used as the threshold for the Test sample

no

optional

Activity

Activity of the (possibly diluted) Test sample

no

mandatory

Below LLOQ

Lower limit at which an assay can provide quantitative results

no

mandatory

CV(%)

CV (coefficient of determination) of the Test sample in percent, per step

'valid' or 'invalid' (if the test is set up)

mandatory

Final activity

Activity of the primary (not diluted) Test sample

'valid', 'invalid', 'passed' or 'failed'

mandatory

Spike

Spike of the PPC

no

mandatory

Activity

Activity of the PPC

no

mandatory

CV(%)

CV (coefficient of determination) of the PPC in percent, per step

'valid' or 'invalid' (if the test is set up)

mandatory

Recovery(%)

Recovery of the PPC in percent

'valid' or 'invalid' (if the test is set up)

mandatory