Hologic ThinPrep Imager Duo - Page 23

MAN-08723-001 Rev. 001 page 19 of 28
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+ Positive Percent Agreement Negative Percent Agreement
Lab CT/
Pathologist
Imaged
(95% CI)
Manual
(95% CI)
Difference
(95% CI)
Imaged
(95% CI)
Manual
(95% CI)
Difference
(95% CI)
90.7% 80.2% 10.5% 86.8% 89.1% -2.3%
#1
(78/86) (69/86) (9/86) (637/734) (654/734) (-17/734)
(82.7% to 95.2%) (70.6% to 87.3%) (2.9% to 18.8%) (84.1% to 89.0%) (86.6% to 91.2%) (-4.6% to -0.1%)
80.9% 74.5% 6.4% 92.1% 92.3% -0.2%
#2
(89/110) (82/110) (7/110) (1038/1127) (1040/1127) (-2/1127)
(72.6% to 87.2%) (65.7% to 81.8%) (-2.0% to 14.7%) (90.4% to 93.5%) (90.6% to 93.7%) (-1.7% to 1.4%)
90.9% 82.7% 8.2% 89.0% 89.7% -0.7%
#3
(100/110) (91/110) (9/110) (1003/1127) (1011/1127) (-8/1127)
(84.1% to 95.0%) (74.6% to 88.7%) (0.7% to 16.0%) (87.0% to 90.7%) (87.8% to 91.3%) (-2.4% to 0.9%)
87.3% 79.1% 8.2% 89.6% 90.5% -0.9%
Combined
(267/306) (242/306) (25/306) (2678/2988) (2705/2988) (-27/2988)
(83.1% to 90.5%) (74.2% to 83.3%) (3.7% to 12.7%) (88.5% to 90.7%) (89.4% to 91.5%) (-1.9% to 0.1%)
In the study, there were 1.83% (23/1260) ThinPrep 5000 slides with UNSAT results by
Adjudication.