MAN-08723-001 Rev. 001 page 21 of 28
The rate of agreement between the Imager-assisted review result and the manual review result from
the previous table is presented below. PPA is the positive percent agreement, percent of specimens
of ASC-H+ diagnosis with Imager-assisted review by a majority of laboratory CT/Pathologists
among all specimens of ASC-H+ diagnosis with manual review by a majority of laboratory
CT/Pathologists. NPA is the negative percent agreement, percent of specimens of
<ASC-H diagnosis with Imager-assisted review by a majority of laboratory CT/Pathologists among
all specimens of <ASC-H diagnosis with manual review by a majority of laboratory
CT/Pathologists.
Table 22: Rate of CT/Pathologist Agreement, ASC-H+
ASC-H+
PPA
89.0% (147/164) (83.3% to 92.9%)
NPA
96.6% (653/676) (95.0% to 97.7%)
In Table 23 for ASCUS+, the number of specimens is shown for which various levels of agreement
among the CTs occurred. Either all three CTs rated the slide as positive (ASCUS+), two out of three
rated it positive, one out of three, or none of them.
Table 23: CT Agreement, All Results, ASCUS+
ASCUS+
Manual Review
Three lab CTs have read the same slide
Totals
Three CTs
had
ASCUS+
Two CTs had
ASCUS+ &
one had
<ASCUS
One CT had
ASCUS+ &
two had
<ASCUS
Three CTs
had
<ASCUS
Imager-
Assisted
Review
Three lab CTs
have read the
same slide
Three CTs had
ASCUS+
272
22
8
0
302
Two CTs had
ASCUS+ and one had
<ASCUS
15
16
6
7
44
One CT had ASCUS+
and two had <ASCUS
7
10
24
38
79
Three CTs had
<ASCUS
0
5
28
382
415
Totals
294 53 66
427
840
ASCUS+
Manual Review
Three lab CTs have read the same slide
Totals
Three or two CTs
had ASCUS+
Three or two CTs
had <ASCUS
Imager-
Assisted
Review
Three lab
CTs have
read the
same slide
Three or two CTs had
ASCUS+
325
21
346
Three or two CTs had
<ASCUS
22
472
494
Totals
347 493
840
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