Hologic ThinPrep Imager Duo Operator's Manual page 23

Table 20: Laboratory Imager-Assisted Review Results vs. Laboratory Manual Review Results
for the Specimens with Reference Diagnosis of HSIL+
In the study, there were 110 specimens with Reference Diagnosis of HSIL+ (combined HSIL and Cancer) and 1,127
specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, LSIL, and ASC-H).
In this table, "Positive" means HSIL+ or UNSAT, and "Negative" means NILM, ASC-US/AGUS, LSIL, or ASC-H. All
percentages are rounded to the nearest 0.1%.
HSIL+
Imaged
Lab CT/
Pathologist
(95% CI)
90.7%
#1 (78/86)
(82.7% to 95.2%)
80.9%
#2 (89/110)
(72.6% to 87.2%)
90.9%
#3
(100/110)
(84.1% to 95.0%)
87.3%
Combined
(267/306)
(83.1% to 90.5%)
In the study, there were 1.83% (23/1260) ThinPrep 5000 slides with UNSAT results by
Adjudication.
Positive Percent Agreement
Manual
(95% CI)
80.2%
(69/86)
(70.6% to 87.3%) (2.9% to 18.8%)
74.5%
(82/110)
(65.7% to 81.8%) (-2.0% to 14.7%)
82.7%
(91/110)
(74.6% to 88.7%) (0.7% to 16.0%)
79.1%
(242/306)
(74.2% to 83.3%) (3.7% to 12.7%)
Difference Imaged
(95% CI) (95% CI)
10.5% 86.8%
(9/86) (637/734)
(84.1% to 89.0%)
6.4% 92.1%
(7/110) (1038/1127)
(90.4% to 93.5%)
8.2% 89.0%
(9/110) (1003/1127)
(87.0% to 90.7%)
8.2% 89.6%
(25/306) (2678/2988)
(88.5% to 90.7%)
Negative Percent Agreement
Manual
(95% CI)
89.1%
(654/734)
(86.6% to 91.2%)
92.3%
(1040/1127)
(90.6% to 93.7%)
89.7%
(1011/1127)
(87.8% to 91.3%)
90.5%
(2705/2988)
(89.4% to 91.5%)
MAN-08723-001 Rev. 001 page 19 of 28
Difference
(95% CI)
-2.3%
(-17/734)
(-4.6% to -0.1%)
-0.2%
(-2/1127)
(-1.7% to 1.4%)
-0.7%
(-8/1127)
(-2.4% to 0.9%)
-0.9%
(-27/2988)
(-1.9% to 0.1%)