Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
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Analytical Performance
This section gives a summary of the Aperio GT 450 DX analytical performance studies.
Trueness
Test
Acceptance Criteria
Test Purpose
Tissue Finder
y
System encompasses all stained portions of
the tissue block at defined success rates for
FFPE H&E-Stained slides – 98% success rate
y
System encompasses all stained portions of
the tissue block at defined success rates for
FFPE IHC Stained slides – 90% success rate
y
System scans ≤ 30% excessive area at a
success rate of 90% for FFPE H&E-stained
slides
y
System scans ≤ 30% excessive area at a
success rate of 90% for FFPE IHC stained slides
Demonstrates that all tissue specimen on
the glass slide is included in the digital
image file.
Focus Error
System has a focus error within the allowable
calculated limits for both auto-focusing and
scanning methods:
y
Focus low : -1.83 microns
y
Focus high : 1.21 microns
Demonstrates that the focus quality of the
Aperio GT 450 DX scanner is acceptable
even in the presence of uneven tissue.
Color
System provides color management using an ICC
profile per established industry guidelines.
Measures the color differences between
the input color stimuli and the output digital
image file.
A
Performance Information
