Hologic ThinPrep Operator's Manual page 21

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+
Imager-Assisted
Lab CT/
Pathologist
(95% CI)
93.9%
#1 (215/229)
(90.0% to 96.3%)
85.0%
#2
(278/327)
(80.7% to 88.5%)
93.9%
#3 (307/327)
(90.7% to 96.0%)
90.6%
Combined (800/883)
(88.5% to 92.4%)
Positive Percent Agreement
Manual
(95% CI)
90.0%
(206/229)
(85.4% to 93.2%) (-0.5% to 8.5%)
88.1%
(288/327)
(84.1% to 91.2%) (-7.0% to 0.8%)
87.5%
(286/327)
(83.4% to 90.6%) (3.2% to 10.0%)
88.3%
(780/883)
(86.0% to 90.3%)
Difference Imager-Assisted
(95% CI) (95% CI)
3.9% 86.1%
(9/229) (509/591)
(83.1% to 88.7%)
-3.1% 87.4%
(-10/327) (795/910)
(85.0% to 89.4%)
6.4% 84.3%
(21/327) (767/910)
(81.8% to 86.5%)
2.3% 85.9%
(20/883) (2071/2411)
(0.1% to 4.5%) (84.5% to 87.2%)
Negative Percent Agreement
Manual
(95% CI)
85.3%
(504/591)
(82.2% to 87.9%)
87.7%
(798/910)
(85.4% to 89.7%)
84.6%
(770/910)
(82.1% to 86.8%)
85.9%
(2072/2411)
(84.5% to 87.3%)
MAN-03938-001 Rev. 002 page 17 of 23
Difference
(95% CI)
0.8%
(5/591)
(-1.7% to 3.5%)
-0.3%
(-3/910)
(-2.3% to 1.6%)
-0.3%
(-3/910)
(-2.4% to 1.7%)
0.0%
(-1/2411)
(-1.3% to 1.2%)