User's Manual

INTENDED USE / RESULTING PRINCIPLES
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MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
2.4 RESULTING PRINCIPLES
The resulting process begins at the end of the biological reaction.
ResultInterpretationImage analysisImagingAnalytical process
It is based on three main phases which are automated on the MosaiQ Software; imaging,
image analysis and interpretation, as described thereafter.
Although the structure of the resulting process is common, certain assay specific
parameters may apply.
2.4.1 IMAGING
Upon completion of the analytical process, the microarray is ready for imaging.
A software controlled high-resolution camera captures a black and white image of the
microarray under assay dependent, controlled illumination conditions. The resulting
image is stored as an image file for subsequent analysis.
2.4.2 IMAGE ANALYSIS
Different metrics are used for image analysis. A parameter called the Signal to Standard
Deviation Ratio (SSR) is used to measure the intensity of the microarray panel spots in
relation to the background. The intensity of each spot is qualified into one of these three
possible states:
 Reactive
 Non-reactive
 Technical Error: if for technical reasons (spot morphology, characteristics of
analyzed spot) the status of the spot cannot be defined as reactive or non-reactive.
The mathematical definition of the SSR is as follows:
With:
 Mean (Signal): Mean value of the grey level of the spot signal calculated on the
area of the spot.
 Mean (Background): Mean value of the grey level of the background surrounding
the spot calculated on the area of the background.
 StD (Background): Standard deviation of the background surrounding the spot,
calculated on the area of the background.
SSR =
Mean (Signal) - Mean (Background)
StD (Background)
2.4.3 INTERPRETATION
Each spot of the panel that has been given one of the 3 possible states is interpreted by
group or individually by the software to determine the reportable result.
The algorithm used for the interpretation is specific to each analyte. For detailed
information about the interpretation algorithms, please refer to the instructions for use
for the related assay.