Hologic ThinPrep Imager Duo - Page 20

MAN-08723-001 Rev. 001 page 16 of 28
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+ 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)
93.8% 95.1% -1.3% 84.4% 81.9% 2.5%
#1
(287/306) (291/306) (-4/306) (434/514) (421/514) (13/514)
(90.5% to 96.0%) (92.1% to 97.0%) (-4.2% to 1.5%) (81.0% to 87.3%) (78.3% to 85.0%) (-0.2% to 5.3%)
91.6% 92.3% -0.6% 84.8% 85.2% -0.4%
#2
(428/467) (431/467) (-3/467) (653/770) (656/770) (-3/770)
(88.8% to 93.8%) (89.5% to 94.4%) (-3.3% to 1.9%) (82.1% to 87.2%) (82.5% to 87.5%) (-2.9% to 2.1%)
91.9% 91.4% 0.4% 83.0% 83.4% -0.4%
#3
(429/467) (427/467) (2/467) (639/770) (642/770) (-3/770)
(89.0% to 94.0%) (88.5% to 93.6%) (-2.1% to 3.0%) (80.2% to 85.5%) (80.6% to 85.8%) (-2.9% to 2.1%)
92.3% 92.7% -0.4% 84.0% 83.7% 0.3%
Combined
(1144/1240) (1149/1240) (-5/1240) (1726/2054) (1719/2054) (7/2054)
(90.6% to 93.6%) (91.1% to 94.0%) (-1.9% to 1.1%) (82.4% to 85.6%) (82.0% to 85.2%) (-1.1% to 1.8%)