Hologic ThinPrep Imager Duo - Page 21

MAN-08723-001 Rev. 001 page 17 of 28
Table 18: Laboratory Imager-Assisted Review Results vs. Laboratory Manual Review Results
for the Specimens with Reference Diagnosis of LSIL+
In the study, there were 327 specimens with Reference Diagnosis of LSIL+ (combined LSIL, ASC-H, HSIL, and Cancer)
and 910 specimens with Reference Diagnosis of (combined NILM, ASC-US, and AGUS).
In this table, “Positive” means LSIL+ or UNSAT, and “Negative” means NILM or ASC-US/AGUS. All percentages are
rounded to the nearest 0.1%.
LSIL+ Positive Percent Agreement Negative Percent Agreement
Lab CT/
Pathologist
Imager-Assisted
(95% CI)
Manual
(95% CI)
Difference
(95% CI)
Imager-Assisted
(95% CI)
Manual
(95% CI)
Difference
(95% CI)
93.9% 90.0% 3.9% 86.1% 85.3% 0.8%
#1
(215/229) (206/229) (9/229) (509/591) (504/591) (5/591)
(90.0% to 96.3%) (85.4% to 93.2%) (-0.5% to 8.5%) (83.1% to 88.7%) (82.2% to 87.9%) (-1.7% to 3.5%)
85.0% 88.1% -3.1% 87.4% 87.7% -0.3%
#2
(278/327) (288/327) (-10/327) (795/910) (798/910) (-3/910)
(80.7% to 88.5%) (84.1% to 91.2%) (-7.0% to 0.8%) (85.0% to 89.4%) (85.4% to 89.7%) (-2.3% to 1.6%)
93.9% 87.5% 6.4% 84.3% 84.6% -0.3%
#3
(307/327) (286/327) (21/327) (767/910) (770/910) (-3/910)
(90.7% to 96.0%) (83.4% to 90.6%) (3.2% to 10.0%) (81.8% to 86.5%) (82.1% to 86.8%) (-2.4% to 1.7%)
90.6% 88.3% 2.3% 85.9% 85.9% 0.0%
Combined
(800/883) (780/883) (20/883) (2071/2411) (2072/2411) (-1/2411)
(88.5% to 92.4%) (86.0% to 90.3%) (0.1% to 4.5%) (84.5% to 87.2%) (84.5% to 87.3%) (-1.3% to 1.2%)