Hologic ThinPrep Operator's Manual page 25

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+
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+
Three CTs had
ASCUS+
Imager-
Two CTs had
Assisted
ASCUS+ and one had
Review
<ASCUS
One CT had ASCUS+
Three lab CTs
and two had <ASCUS
have read the
same slide
Three CTs had
<ASCUS
Totals
ASCUS+
Imager-
Assisted Three or two CTs had
Review ASCUS+
Three lab
CTs have Three or two CTs had
read the
<ASCUS
same slide
Totals
PPA
89.0% (147/164)
NPA 96.6% (653/676)
Three lab CTs have read the same slide
Two CTs had
Three CTs
had
ASCUS+
272
15
7
0
294
Three lab CTs have read the same slide
Three or two CTs
had ASCUS+
325
22
347
(83.3% to 92.9%)
(95.0% to 97.7%)
Manual Review
One CT had
ASCUS+ & ASCUS+ &
one had two had
<ASCUS <ASCUS
22 8
16 6
10 24
5 28
53 66
Manual Review
Three or two CTs
had <ASCUS
Three CTs
had Totals
<ASCUS
0 302
7 44
38 79
382 415
427 840
Totals
21 346
472 494
493 840
MAN-03938-001 Rev. 002 page 21 of 23