Hologic ThinPrep Operator's Manual page 17

Table 14: Cytotechnologist Screening Rates
Site/CT
Site 1
1-1
1-2
Site 2
2-1
2-2
Site 3
3-1
3-2
Site 4
4-1
4-2
Table 15 summarizes the Manual Review versus the Imager Review for ASCUS+ and HSIL+
sensitivity and specificity by site. The table also presents the prevalence of ASCUS+, LSIL+, and
HSIL+ among the reviewed slides and the respective screening daily rates of each review method.
The daily screening rates are extrapolated to an 8-hour workday and are presented as the low,
average and high daily screening rates by site.
Table 15: Screening Rates, Prevalence of ASCUS+, LSIL+, HSIL+, and Respective
Performance for ASCUS+ and HSIL+.
Site % of % of % of
ASCUS+ LSIL+ HSIL+
Site 1 7.7% 4.5% 1.6%
Site2 9.2% 4.0% 1.6%
Site 3
4.4% 2.7% 1.0%
Site 4 7.2% 4.5% 1.6%
The clinical study data show that the screening rates achieved with the ThinPrep
resulted in sensitivity or specificity values that fall within acceptable limits.
Total
Review Number of
Methods Slides
Evaluated
Manual 2568
Imager 2297
Manual 1284
Imager 1168
Manual 1284
Imager 1129
Manual 2686
Imager 2665
Manual 1348
Imager 1309
Manual 1338
Imager 1356
Manual 2738
Imager 2726
Manual 1368
Imager 1460
Manual 1370
Imager 1266
Manual 2612
Imager 2524
Manual 1305
Imager 1252
Manual 1307
Imager 1272
Review Extrapolated Daily Rates
Methods (8-hour workday)
Low Average
Day Day
Manual 49 69
Imager 107 153
Manual 40 68
Imager 69 109
Manual 20 80
Imager 148 204
Manual 42 69
Imager 86 138
Average Extrapolated Daily Rates
Number of
Hours
Low
Screened Per
Day
Day
7.4 49
6.0 107
7.5 49
6.1 117
7.3 70
5.9 107
7.7 40
7.8 69
7.6 40
7.9 97
7.8 55
7.7 69
7.9 20
4.5 148
7.9 63
4.2 167
7.8 20
4.7 148
7.6 42
5.1 86
8.2 59
5.1 86
6.9 42
5.0 109
Performance for
ASCUS+
High Sensitivity
Day
94 77.2% 98.7%
+1.1%
206 78.3% 99.2%
80 63.1% 95.8%
+14.4%
131 77.7% 96.1%
101 80.6% 98.5%
+13.6%
320 94.2% 98.8%
94 87.2% 97.3%
-2.8%
198 84.4% 97.0%
(8-hour workday)
Average High
Day Day
69 94
153 206
60 72
153 182
78 94
154 206
68 80
109 131
71 80
110 118
66 75
109 131
80 101
204 320
82 91
230 320
78 101
178 212
69 94
138 198
75 84
150 190
63 94
126 198
Performance for
Specificity Sensitivity
89.5%
+0.4% +2.6%
92.1%
72.5%
+0.3% -2.5%
70.0%
64.3%
+0.4% +13.6%
78.6%
61.5%
-0.3% +12.8%
74.4%
®
Imaging System
MAN-03938-001 Rev. 002 page 13 of 23
HSIL+
Specificity
98.8%
+0.7%
99.5%
99.8%
-0.1%
99.6%
99.7%
0%
99.7%
99.5%
+0.3%
99.8%