Hologic ThinPrep Imager Duo Operator's Manual page 15

Table 12: Unadjudicated Marginal Frequencies Summary of Specimen Adequacy
Results – All Sites Combined.
Number of Patients:
Descriptive Diagnosis
Satisfactory for Evaluation
Satisfactory but Limited by
Endocervical Component Absent
Scant Squamous Epithelial Component
Obscuring Blood
Obscuring Inflammation
No Clinical History
Cytolysis
Other
Unsatisfactory for Evaluation
Endocervical Component Absent
Scant Squamous Epithelial Component
Obscuring Blood
Obscuring Inflammation
No Clinical History
Cytolysis
Other
Note: Some patients had more than one diagnostic subcategory.
For SAT cases, there was agreement between the Manual Review cases (7375) and the Imager
Review cases (7346). For SBLB cases, there is agreement between the Manual Review cases (2186)
and the Imager Review cases (2252). Unsatisfactory cases were greater in the Manual Review cases
(66) versus the Imager Review cases (29).
The adjudicated results were used as a "gold standard" to define "true" specimen adequacy
classifications of the Bethesda System: SAT/SBLB and UNSAT. There were 58 "true" UNSAT
cases and 9569 "true" SAT/SBLB cases.
Table 13 below summarizes specimen adequacy performance for the Imager Review and Manual
Review arms for all four sites and all sites combined using the Bethesda System 1991 criteria.
Table 13: Adjudicated Review Versus Imager Review Specimen Adequacy
Summary for All Sites and All Sites Combined.
Sensitivity is a percent of "true" UNSAT slides classified in either study arm as UNSAT and specificity is a percent of
"true" SAT/SBLB slides classified in either study arm as SAT/SBLB.
Sensitivity
Site/
Number Manual
Cases
0%
Site 1
21
(0/21)
100%
Site 2
6
(6/6)
80.0%
Site 3
5
(4/5)
30.8%
Site 4
26 (8/26)
29.3%
All
58
(17/58)
CI*
(18.1, 42.7)
*95% Confidence Interval
Manual Review
N
7375
2186
1196
92
45
69
982
4
6
66
6
35
17
8
2
0
2
Site/
Imager Difference Number
Cases
0% 0.0%
Site 1
2292
(0/21) (0/21)
16.7% -83.3%
Site 2
2476
(1/6) (-5/6)
60.0% -20.0%
Site 3
2323
(3/5) (-1/5)
19.2% -11.5%
Site 4
(5/26) (-3/26) 2478
13.8% -15.5% All
9569
(8/58) (-9/58)
CI*
(-25.9, -5.0)
(6.1, 25.4)
Imager Review
9627 9627
% N
76.6 7346
22.7 2252
12.4 1397
1.0 102
0.5 17
0.7 68
10.2 933
0.0 2
0.1 33
0.7 29
0.1 0
0.4 22
0.2 2
0.1 5
0.0 2
0.0 0
0.0 0
Specificity
Manual Imager
100% 100%
(2292/2292) (2292/2292)
98.9% 99.6%
(2449/2476) (2465/2476)
99.2% 99.7%
(2304/2323) (2315/2323)
99.9% 99.9%
(2475/2478) (2476/2478)
99.5% 99.8%
(9520/9569) (9548/9569)
(99.3, 99.6) (99.7, 99.9)
MAN-08723-001 Rev. 001 page 11 of 28
%
76.3
23.4
14.5
1.1
0.2
0.7
9.7
0.0
0.3
0.3
0.0
0.2
0.0
0.1
0.0
0.0
0.0
Difference
0.0%
(0/2292)
+0.6%
(16/2476)
+0.5%
(11/2323)
+0.04%
(1/2478)
+0.3%
(28/9569)
(0.2, 0.4)