Hologic Genius, Operator'S Manual

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Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 9/13
Table 6. Coccobacilli Detection:
Agreement between TIS-assisted Review and OOI Study Results
COCCO
TIS
- +
OOI
-
203 5
+
21 28
Agreement
Rates
PPA
85% (69%, 93%)
NPA
91% (86%, 94%)
Detection
Rates
TIS
12.8% (9.3%, 17.5%)
OOI
19.1% (14.7%, 24.3%)
(Diff)
-6.2% (-10.3%, -2.3%)
The detection rate for Coccobacilli for the Genius Digital Diagnostics System was 19.1%,
compared to 12.8% for TIS-assisted review. Further inspection of these cases indicated that
bacteria were indeed present in moderate quantities on some cells. In this study, the CTs were
required to mark the type of each OOI presented, so Coccobacilli would be noted if any normal
cells with bacteria overlaid were presented in the gallery. During a TIS-assisted review, and in
clinical practice, bacterial infection is typically noted only when it is considered of possible clinical
significance (so-called “clue” cells or a large number of infected cells). The difference in detection
rates in the study is due to this difference in counting methodology and would not necessarily be
reflected in clinical practice.
Overall, the presentation of infectious organisms by the algorithm is equivalent or higher than
with TIS-assisted review.
CELL COUNT STUDY
A study was conducted to evaluate the performance of the cell count metric produced by the
Genius Cervical AI algorithm compared to a manual cell count.
ThinPrep Pap test patient sample slides were prepared on a ThinPrep processor, stained and
coverslipped. The same slides were imaged on three Genius Digital Imagers three separate
times. To obtain the manual cell count for the slides in the study, a CT viewed the whole slide
image presented on the Genius Review Station, counted the cells presented in a portion of the
cell spot image, and estimated the total number of cells based on the portion, similar to the
normal process for counting cells on slides viewed on a microscope. The cell counts derived on
each Digital Imager by the algorithm in the Genius Digital Diagnostics system were compared to
the manual cell count estimate.