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Clinical Study Design
The study was a prospective, multi-center, blinded evaluation of ThinPrep slides of known
diagnoses generated from residual cytological specimens which were prepared, reviewed and
adjudicated in a previous study.
One thousand two hundred sixty (1260) slides were prepared on a ThinPrep 5000 processor and
were reviewed independently by a Cytotechnologist and confirmed by a Pathologist. All cytologic
diagnoses were determined in accordance with the Bethesda System 2001 criteria for all slides
study was conducted at Hologic, Inc., Marlborough, MA and at two external laboratories in the
United States.
Table 16: Laboratory Imager-Assisted Review Diagnosis vs. Laboratory Manual Review
Diagnosis by one Pair of Cytotechnologist/Pathologist (Combined Sites)
Lab
Imager-
Assisted
Review
UNSAT
Diagnosis
UNSAT
30
NILM
10
ASC-US
3
AGUS
0
LSIL
0
ASC-H
2
HSIL
1
Cancer
1
Total
47
Reference Diagnosis by Adjudication Review
All slides were subject to an adjudication review. Adjudication was done at a facility that was not
one of the study sites conducting the study. Slides for adjudication were evenly divided between
three (3) adjudication panels each consisting of one (1) Cytotechnologist and three (3) independent
Pathologists. Each adjudication panel was blinded to the original review diagnosis for all slides and
each independent Pathologist within each panel was also blinded to other adjudicator's diagnoses
for all slides. Adjudication consensus agreement was obtained for each slide reviewed. Consensus
agreement was achieved when at least two (2) of the three (3) Pathologists from a panel rendered an
identical diagnosis. In cases where consensus agreement was not achieved the panel members were
brought together at a multi-head microscope to review the slides together and come to a consensus
diagnosis.
In the study, there were 18 Cancer, 92 HSIL, 37 ASC-H, 180 LSIL, 18 AGUS, 122 ASC-US, 770
NILM, and 23 UNSAT specimens. Clinical sensitivity and specificity (e.g., with reference to a
histological diagnosis) cannot be measured in this study which relied on cytological examination
alone. Instead, laboratory positive and negative diagnoses by both methods, Imager-assisted and
manual review, for the specimens with Reference Diagnosis of ASC-US+ (combined ASC-US,
AGUS, LSIL, ASC-H, HSIL, and Cancer), LSIL+ (combined LSIL, ASC-H, HSIL, and Cancer),
ASC-H+ (combined ASC-H, HSIL, and Cancer) and HSIL+ (combined HSIL and Cancer) were
compared.
Lab Manual Review Diagnosis
NILM
ASC-US
AGUS
10
2
0
620
36
1
40
35
10
10
28
127
4
9
4
2
1
0
3
6
15
0
0
0
689
117
157
LSIL
ASC-H
HSIL
1
0
0
5
5
3
8
1
2
8
0
8
14
2
13
1
3
1
24
2
111
1
1
7
62
14
145
MAN-03938-001 Rev. 002 page 15 of 23
1
. The
Cancer
Total
0
43
1
681
0
99
0
181
0
46
2
12
5
167
21
31
29
1260
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