MAN-04008-001 Rev. 001 Page 14 of 27
Table 14: Specimen Adequacy Results by Site
Site
Cases
ThinPrep
SAT
Cases
Con
ent.
SAT
Cases
ThinPrep
SBLB
Cases
Con
ent.
SBLB
Cases
ThinPrep
UNSAT
Cases
Con
ent.
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 (%)
Con
entional
SBLB- no
ECC’s
Con
entional
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.
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