Hologic ThinPrep Imager Duo - Page 22

MAN-08723-001 Rev. 001 page 18 of 28
Table 19: Laboratory Imager-Assisted Review Results vs. Laboratory Manual Review Results
for the Specimens with Reference Diagnosis of ASC-H+
In the study, there were 147 specimens with Reference Diagnosis of ASC-H+ (combined ASC-H, HSIL, and Cancer) and
1,090 specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, and LSIL).
In this table, “Positive” means ASC-H+ or UNSAT, and “Negative” means NILM, ASC-US/AGUS, or LSIL. All
percentages are rounded to the nearest 0.1%.
ASC-H+ 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)
93.7% 88.3% 5.4% 86.7% 86.7% 0.0%
#1
(104/111) (98/111) (6/111) (615/709) (615/709) (0/709)
(87.6% to 96.9%) (81.0% to 93.0%) (-0.6% to 12.0%) (84.0% to 89.0%) (84.0% to 89.0%) (-2.2% to 2.2%)
86.4% 86.4% 0.0% 89.4% 89.4% -0.1%
#2
(127/147) (127/147) (0/147) (974/1090) (975/1090) (-1/1090)
(79.9% to 91.0%) (79.9% to 91.0%) (-6.8% to 6.8%) (87.4% to 91.1%) (87.5% to 91.1%) (-1.8% to 1.6%)
95.2% 89.8% 5.4% 88.2% 87.4% 0.7%
#3
(140/147) (132/147) (8/147) (961/1090) (953/1090) (8/1090)
(90.5% to 97.7%) (83.8% to 93.7%) (-0.1% to 11.4%) (86.1% to 90.0%) (85.3% to 89.3%) (-1.0% to 2.5%)
91.6% 88.1% 3.5% 88.3% 88.0% 0.2%
Combined
(371/405) (357/405) (14/405) (2550/2889) (2543/2889) (7/2889)
(88.5% to 93.9%) (84.6% to 90.9%) (0.0% to 7.0%) (87.0% to 89.4%) (86.8% to 89.2%) (-0.8% to 1.3%)