Hologic ThinPrep 5000 Instruction Manual page 14

Site Cases
S1 1,386
S2 1,668
S3 1,093
H1 1,046
H2 1,049
H3
All Sites 7,223
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
Site Cases
S1 1,386
S2 1,668
1,093
S3
H1 1,046
1,049
H2
H3 981
7,223
All Sites
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
directly into a PreservCyt
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.
Table 14: Specimen Adequacy Results by Site
ThinPrep Convent.
SAT SAT
Cases Cases
1092 1178
1530 1477
896 650
760 660
709 712
981 669 424
5656 5101
Table 15: Specimen Adequacy Results by Site,
SBLB Rates for no Endocervical Component
SBLB Due to No ECC's
ThinPrep
SBLB- no
ECC's no ECC's (%)
237
104
145
229
305
120
1140
®
2000 system, the cervical sampling device will be rinsed
®
vial, rather than splitting the cellular sample. It was expected that this
ThinPrep Convent.
SBLB SBLB
Cases Cases
265 204
130 178
183 432
266 375
323 330
264 489
1431 2008
ThinPrep Conventional
SBLB-
SBLB- no
ECC's
17.1% 162
6.2% 73
13.3% 84
21.9% 115
29.1% 150
12.2% 97
15.8% 681
ThinPrep Convent.
UNSAT UNSAT
Cases Cases
29 4
8 13
14 11
20 11
17 7
48 68
136 114
®
and conventional slides.
Conventional
SBLB-
no ECC's (%)
11.7%
4.4%
7.7%
11.0%
14.3%
9.9%
9.4%
MAN-04008-001 Rev. 001 Page 14 of 27