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):

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

Special values for the Activity and Final activity elements

For the Activity and the Final activity elements in the report, in certain cases it is not possible to calculate a real numerical value.

The following table shows these values and the possible reasons:


Value	Possible reasons	Remarks
(empty string)	No valid responses
NaN (Not a Number)	Every valid response matches one of the following criteria:	No response must match the condition for INF.
	Response is a technical outlier
	Interpolated dose for response > upper limit of quantification, that is the largest calculation-relevant dose of the standard
	Interpolation formula leads to an unquantifiable value for the response	Fallback if NaN values are generated during the calculation (for example: Response > upper asymptote)
	Interpolated dose to response is negative	Can only occur with the 4-parameter logistic model, as the linear model is delogarithmized to calculate the interpolated dose.
INF	Numerical limit is exceeded.	Can only occur with the Final activity element. Example: If the Activity element is finite and, when multiplied with the dilution factor, becomes larger than the largest numerical number that can be represented (approx. 10^300).

Note: Usually, the Final activity is calculated as Activity by Dilution factor. If the Activity has already an empty string or NaN as value, then the value of Final activity becomes an empty string or NaN, too.