Assay elements
In PLA 3.0, assay elements are the building blocks of assay documents. bioMérieux endotoxin detection assay documents can contain up to four types of assay elements, which represent the reference standard, test samples, blank controls, and positive product control (PPC) controls.
Standard
The Standard element defines the reference standard of the assay document. You define the dilution sequence of the standard as a geometric sequence employing parameters for the number of steps, the initial working concentration in EU/ml, and the base of the sequence.
Every assay document has exactly one Standard element. You can neither remove nor duplicate this element.
Test
The Test element lets you combine information on the test sample such as dilution factor, endotoxin limits, and number of replicates with its associated PPC. The PPC spike setting indicates the amount of endotoxin added to the otherwise exact same test sample substance.
You can add as many Test elements as you require.
Blank control
The Blank control element lets you define the blank control sample that has neither an active ingredient nor an endotoxin added to it. The assay kits from bioMérieux use this sample to adjust the standard in the case of a linear fit. When using a linear model for assay analysis, using a Blank control element is therefore mandatory.
You can add as many Blank control elements as you require.
PPC control
The PPC control element lets you define the PPC control sample. This sample typically only contains dilutant and endotoxin at a known concentration. The endotoxin level measured in this sample is therefore mainly due to the PPC control spike, that is, the amount of endotoxin added to the PPC control. The PPC control sample does not affect the calculation or the validity of the document.
You can add as many PPC control elements as you require.