Hologic ThinPrep Operator's Manual page 19

Table 16. Summarized Results of Within-instrument Study
Dx Imager
TIS
NILM
I2
TIS
ASCUS
I2
TIS
LSIL
I2
TIS
ASC-H
I2
TIS
AGUS
I2
TIS
HSIL
I2
TIS
CANCER
I2
TIS
UNSAT
I2
Between-instrument Reproducibility
Between-instrument reproducibility results were derived from the clinical study. In the clinical
study, three (3) cytotechnologist/pathologist pairs reviewed slides on different instruments.
In Table 17, the between-instrument results are summarized for each diagnostic category of
slides (according to adjudicated truth results). For each grouping, the following metrics are
reported:

% Abnormal
The proportion of slides for which any abnormal diagnosis was recorded.
(For NILM or UNSAT slides, the % Normal column is used to record the proportion that are
not abnormal).

% Category+
The proportion of slides for which the site diagnosis was equal to or higher than the slide's
adjudicated category.
% %
Abnormal Category+
75.9% 75.9%
71.9% 71.9%
97.3% 93.2%
96.0% 94.0%
93.3% 86.7%
100% 83.3%
63.0% 51.9%
55.6% 48.1%
98.0% 77.3%
97.3% 71.3%
100% 46.7%
100% 53.3%
% %
Normal N/A
% zero
69.6% 11.0% 70.4%
78.1% 4.3% 78.4%
13.3% 25.0%
5.0% 28.1%
3.3% 2.8%
0.7% 4.0%
0.0% 6.7%
0.0% 0.0%
6.7% 35.7%
10.0% 44.4%
0.0% 2.0%
0.7% 2.7%
0.0% 0.0%
0.0% 0.0%
72.2% 40.0% 72.2%
85.7% 36.7% 94.7%
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Abnormal FOV
Median
0
0
6
7
14
15
11.5
14
2
2
20
20
22
22
0
0