Hologic Genius, Руководство оператора

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Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 6/13
Study Results: ECC Detection on Normal Cases
Endocervical component (ECC) presence is noted during slide review to confirm adequate
cellular sampling. ECC consists of either endocervical or squamous metaplastic cells. Because
the Genius Digital Diagnostics cervical cancer algorithm prioritizes the presentation of abnormal
cells when they are present, ECC detection was assessed in this study on the subset of slides
deemed normal (NILM) by TIS-assisted review.
Table 3 shows the relationship of ECC presence on TIS-assisted versus OOI gallery review. In
each case, the “+” or “-” corresponds to ECC present or absent, respectively. The count of slides
in each category is shown in the table.
Table 3. ECC Detection on Normal Cases:
Agreement between TIS-assisted Review and OOI Study Results
ECC
TIS
- +
OOI
-
4 2
+
31 59
Agreement
Rates
PPA
97% (89%, 99%)
NPA
11% (5%, 26%)
Detection
Rates
TIS
64% (54%, 72%)
OOI
94% (89%, 99%)
(Diff)
-30% (-40%, -20%)
The positive and negative percent agreement (PPA and NPA) were calculated with reference to
the TIS-assisted result. In addition, the detection rates and difference have also been provided.
Confidence intervals for the proportions are calculated using the Newcombe score method and
account for correlation between the matched pairs.
The ECC detection rate for OOI review was 94%, compared to 64% for TIS-assisted review. There
were 31 NILM slides for which ECC was marked as present in the OOI gallery but not noted in
TIS-assisted review. Upon further inspection of those cases, the ECC consisted of rare squamous
metaplastic cells, which were not noted during the TIS-assisted review.