MAN-02060-001 Rev. 005 page 11 of 14
Table 14: Specimen Adequacy Results by Site
Site
Cases
Thin
Prep
SAT
Cases
Con-
vent.
SAT
Cases
Thin
Prep
SBLB
Cases
Con-
vent.
SBLB
Cases
Thin
Prep
UNSAT
Cases
Con-
vent.
UNSAT
Cases
S1
1,386 1092 1178 265 204
29
4
S2
1,668 1530 1477 130 178
8
13
S3
1,093
896 650 183 432 14
11
H1
1,046
760 660 266 375 20
11
H2
1,049
709 712 323 330 17
7
H3
981 669 424 264 489 48
68
All Sites
7,223 5656 5101 1431 2008 136
114
The Satisfactory But Limited By (SBLB) category can be broken down into many subcategories,
one of which is the absence of Endocervical Component. Table 15 shows the Satisfactory But
Limited By category “No ECC’s” for ThinPrep
®
and conventional slides.
Table 15: Specimen Adequacy Results by Site, SBLB Rates for no Endocervical Component.
SBLB Due to No ECC’s
Site
Cases
ThinPrep
SBLB-
no ECC’s
ThinPrep
SBLB-
no ECC’s (%)
Conventional
SBLB-
no ECC’s
Conventional
SBLB-
no ECC’s (%)
S1
1,386 237
17.1%
162
11.7%
S2
1,668 104
6.2%
73
4.4%
S3
1,093 145
13.3%
84
7.7%
H1
1,046 229
21.9%
115
11.0%
H2
1,049 305
29.1%
150
14.3%
H3
981 120 12.2%
97
9.9%
All Sites
7,223 1140
15.8%
681
9.4%
For the results of the clinical study involving a split-sample protocol, there was a 6.4 percent difference
between conventional and ThinPrep methods in detecting endocervical component. This is similar to
previous studies using a split sample methodology.
DIRECT-TO-VIAL ENDOCERVICAL COMPONENT (ECC) STUDIES
For the intended use of the ThinPrep
®
2000 System, the cervical sampling device will be rinsed directly
into a PreservCyt
®
vial, rather than splitting the cellular sample. It was expected that this would result in
an increase in the pick-up of endocervical cells and metaplastic cells. To verify this hypothesis, two studies
were performed using the direct-to-vial method and are summarized in Table 16. Overall, no difference
was found between ThinPrep and conventional methods in these two studies.
