Hologic ThinPrep Imager Duo Operator's Manual page 20

Clinical Study Results
Tables 17 through 20 present the comparison of Laboratory true positive and negative rates for
ASC-US+, LSIL+, ASC-H+, and HSIL+.
Table 17: Laboratory Imager-Assisted Review Results vs. Laboratory Manual Review Results
for the Specimens with Reference Diagnosis of ASC-US+
In the study, there were 467 specimens with Reference Diagnosis of ASC-US+ (combined ASC-US, AGUS, LSIL, ASC-H,
HSIL, and Cancer) and 770 specimens with Reference Diagnosis of NILM.
In this table, "Positive" means ASC-US+ or UNSAT, and "Negative" means NILM. All percentages are rounded to the
nearest 0.1%.
ASC-US+
Imager-Assisted
Lab CT/
Pathologist
(95% CI)
93.8%
#1 (287/306)
(90.5% to 96.0%)
91.6%
#2 (428/467)
(88.8% to 93.8%)
91.9%
#3
(429/467)
(89.0% to 94.0%)
92.3%
Combined
(1144/1240)
(90.6% to 93.6%)
Positive Percent Agreement
Manual
(95% CI)
95.1%
(291/306)
(92.1% to 97.0%) (-4.2% to 1.5%)
92.3%
(431/467)
(89.5% to 94.4%) (-3.3% to 1.9%)
91.4%
(427/467)
(88.5% to 93.6%) (-2.1% to 3.0%)
92.7%
(1149/1240)
(91.1% to 94.0%) (-1.9% to 1.1%)
Difference Imager-Assisted
(95% CI) (95% CI)
-1.3% 84.4%
(-4/306) (434/514)
(81.0% to 87.3%)
-0.6% 84.8%
(-3/467) (653/770)
(82.1% to 87.2%)
0.4% 83.0%
(2/467) (639/770)
(80.2% to 85.5%)
-0.4% 84.0%
(-5/1240) (1726/2054)
(82.4% to 85.6%)
Negative Percent Agreement
Manual
(95% CI)
81.9%
(421/514)
(78.3% to 85.0%)
85.2%
(656/770)
(82.5% to 87.5%)
83.4%
(642/770)
(80.6% to 85.8%)
83.7%
(1719/2054)
(82.0% to 85.2%)
MAN-08723-001 Rev. 001 page 16 of 28
Difference
(95% CI)
2.5%
(13/514)
(-0.2% to 5.3%)
-0.4%
(-3/770)
(-2.9% to 2.1%)
-0.4%
(-3/770)
(-2.9% to 2.1%)
0.3%
(7/2054)
(-1.1% to 1.8%)