Hologic Genius, Руководство оператора

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Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 7/13
Infectious Organism Detection
The presence of infectious organisms is noted as part of slide review to help in the clinical
assessment of the case. In this study, slides were enrolled that included three classes of
organism: Trichomonas, Candida, and Coccobacilli. The tables below compare the detection of
each organism on TIS-assisted review and review of OOIs in the gallery of a Genius Digital
Diagnostic Review Station. For each table, the positive and negative agreement rates with
reference to the TIS-assisted result are provided. The overall detection rate for each organism
and the difference in detection rates (TIS – OOI) are also included.
Table 4. Trichomonas Detection:
Agreement between TIS-assisted Review and OOI Study Results
TRICH
TIS
- +
OOI
-
246 1
+
2 8
Agreement
Rates
PPA
89% (57%, 98%)
NPA
99% (97%, 100%)
Detection
Rates
TIS
3.5% (1.9%, 6.5%)
OOI
3.9% (2.1%, 7.0%)
(Diff)
-0.4% (-2.5%, 1.6%)
The detection rate for Trichomonas for the Genius Digital Diagnostics System was 3.9%,
compared to 3.5% for TIS-assisted review.