MAN-04008-001 Rev. 001 Page 21 of 27
ThinPrep 2000 System
Three lab CTs have read the same ThinPrep 2000 slide from a vial
Three CTs
had
ASCUS+
wo CTs had
ASCUS+ &
one had <ASCUS
One CT had
ASCUS+ &
Three CTs
had
<ASCUS
ThinPrep
5000
Processor
Three lab
CTs have
read the
same
ThinPrep
5000 slide
from a vial
Three CTs had
ASCUS+
393 36 8
4
441
wo CTs had
ASCUS+ and one
had <ASCUS
31 24 13
10 78
One CT had
ASCUS+ and two
had <ASCUS
11 8 34
53 106
Three CTs had
<ASCUS
3 13 56
563 635
438 81 111 630 1260
ThinPrep 2000 S
stem
Three lab CTs have read the same
ThinPrep 2000 slide from a vial
Totals
Three or two CTs
had ASCUS+
Three or two CTs
had <ASCUS
ThinPrep 5000
Processor Three
lab CTs have read
the same
ThinPrep 5000 slide
from a vial
Three or two CTs
had ASCUS+
484 35
519
Three or two CTs
had <ASCUS
35 706
741
Totals
519 741 1260
The rate of agreement between the ThinPrep 5000 result and the ThinPrep 2000 result from the previous
table is presented below. PPA is the positive percent agreement, percent of specimens of ASC-H+
diagnosis with ThinPrep 5000 slides by a majority of laboratory CT/Pathologists among all specimens
of ASC-H+ diagnosis with ThinPrep 2000 slides by a majority of laboratory CT/Pathologists. NPA is
the negative percent agreement, percent of specimens of <ASC-H diagnosis with ThinPrep 5000 slides
by a majority of laboratory CT/Pathologists among all specimens of <ASC-H diagnosis with ThinPrep
2000 slides by a majority of laboratory CT/Pathologists.
Table 25: Rate of CT/Pathologist Agreement, ASC-H+
ASC-H+
PPA 88.2% (194/220) (83.3% to 91.8%)
NPA 96.7% (1006/1040) (95.5% to 97.7%)
In Table 26 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 26: CT Agreement, All Results, ASCUS+
ASCUS+
Totals
Totals
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