MAN-04008-001 Rev. 001 Page 19 of 27
Table 22: Laboratory ThinPrep 5000 Results vs Laboratory ThinPrep 2000 Results for the Specimens
with Reference Diagnosis of ASC-H+
In the study, there were 185 specimens with Reference Diagnosis of ASC-H+ (combined ASC-H, HSIL, and
Cancer) and 1,041 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
ThinPrep 5000
(95% CI)
ThinPrep 2000
(95% CI)
Difference
(95% CI)
ThinPrep 5000
(95% CI)
ThinPrep 2000
(95% CI)
Difference
(95% CI)
#1
81.6%
(151/185)
(75.4% to 86.5%)
84.3%
(156/185)
(78.4% to 88.9%)
-2.7%
(-5/185)
(-8.6% to 3.2%)
90.6%
(943/1041)
(88.7% to 92.2%)
90.6%
(943/1041)
(88.7% to 92.2%)
0.0%
(0/1041)
(-1.6% to 1.6%)
#2
81.6%
(151/185)
(75.4% to 86.5%)
81.1%
(150/185)
(74.8% to 86.1%)
0.5%
(1/185)
(-6.0% to 7.1%)
91.7%
(955/1041)
(89.9% to 93.3%)
91.1%
(948/1041)
(89.2% to 92.7%)
0.7%
(7/1041)
(-1.0% to 2.3%)
#3
85.4%
(158/185)
(79.6% to 89.8%)
84.9%
(157/185)
(79.0% to 89.3%)
0.5%
(1/185)
(-5.4% to 6.5%)
89.8%
(935/1041)
(87.8% to 91.5%)
90.6%
(943/1041)
(88.7% to 92.2%)
-0.8%
(-8/1041)
(-2.5% to 0.9%)
Table 23: Laboratory ThinPrep 5000 Results vs Laboratory ThinPrep 2000 Results for the Specimens
with Reference Diagnosis of HSIL+
In the study, there were 146 specimens with Reference Diagnosis of HSIL+ (combined HSIL and Cancer) and
1,080 specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, LSIL, and ASC-H).
In this table, “Positive” means HSIL+ or UNSAT, and “Negative” means NILM, ASC-US/AGUS,
LSIL, or ASC-H. All percentages are rounded to the nearest 0.1%.
HSIL+
Positive Percent Agreement Negative Percent Agreement
Lab CT/
Pathologist
ThinPrep 5000
(95% CI)
ThinPrep 2000
(95% CI)
Difference
(95% CI)
ThinPrep 5000
(95% CI)
ThinPrep 2000
(95% CI)
Difference
(95% CI)
#1
77.4%
(113/146)
(70.0% to 83.4%)
80.1%
(117/146)
(72.9% to 85.8%)
-2.7%
(-4/146)
(-9.8% to 4.3%)
93.2%
(1007/1080)
(91.6% to 94.6%)
93.2%
(1007/1080)
(91.6% to 94.6%)
0.0%
(0/1080)
(-1.4% to 1.4%)
#2
69.9%
(102/146)
(62.0% to 76.7%)
74.7%
(109/146)
(67.0% to 81.0%)
-4.8%
(-7/146)
(-11.8% to 2.3%)
94.3%
(1018/1080)
(92.7% to 95.5%)
94.7%
(1023/1080)
(93.2% to 95.9%)
-0.5%
(-5/1080)
(-1.9% to 1.0%)
#3
78.1%
(114/146)
(70.7% to 84.0%)
82.9%
(121/146)
(75.9% to 88.1%)
-4.8%
(-7/146)
(-12.6% to 3.1%)
91.9%
(992/1080)
(90.1% to 93.3%)
92.3%
(997/1080)
(90.6% to 93.8%)
-0.5%
(-5/1080)
(-2.1% to 1.2%)
In the study, there were 2.06% (26/1260) ThinPrep 2000 slides with UNSAT results by Adjudication and 1.83%
(23/1260) ThinPrep 5000 slides with UNSAT results by Adjudication.
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