Hologic Genius, Руководство оператора

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Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 5/13
absolute accuracy; the study compared TIS-assisted review with the OOIs on the Genius Digital
Diagnostics System.
Table 1. Slides Enrolled in the OOI Study
Category # of slides
NILM 99
ASCUS 6
LSIL 60
ASC-H 8
AGUS 10
HSIL 60
CANCER 16
Study Results: Cervical Cytology Diagnostic Categories
The highest OOI category for any case across the nine runs of the case on the Genius Digital
Diagnostics System was compared to the diagnostic category for the same slide in the TIS-
assisted review. Table 2 shows the relationship between the Genius Digital Diagnostic System
results and the TIS-assisted results.
Table 2. TIS-assisted Results vs. Genius Digital Diagnostic System OOIs
TIS
UNSAT NILM ASCUS LSIL ASC-H AGUS HSIL CANCER Total
OOI
NILM
2 83 4 0 0 2 0 0 91
ASCUS
0 10 6 3 1 0 0 0 20
LSIL
0 0 5 27 0 0 1 0 33
ASC-H
0 1 5 11 2 0 7 0 26
AGUS
0 2 0 0 0 5 1 1 9
HSIL
0 0 2 2 2 1 49 5 61
CANCER
0 0 0 0 1 1 6 9 17
2 96 22 43 6 9 64 15
The study showed an average of 6.8 OOIs in tiles per case on the Genius Digital Diagnostic
System matched the TIS-assisted diagnosis. The standard deviation was 1.3. These results
demonstrate that the Genius Digital Diagnostic System accurately selects OOIs of most interest
for diagnosis. And, the results are repeatable across multiple instruments and multiple runs.