Hologic ThinPrep 5000 Instruction Manual page 19
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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+
Lab CT/
ThinPrep 5000
Pathologist
(95% CI)
81.6%
#1
(151/185)
(75.4% to 86.5%)
81.6%
#2
(151/185)
(75.4% to 86.5%)
85.4%
#3
(158/185)
(79.6% to 89.8%)
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+
Lab CT/
ThinPrep 5000
Pathologist
(95% CI)
77.4%
#1
(113/146)
(70.0% to 83.4%)
69.9%
#2
(102/146)
(62.0% to 76.7%)
78.1%
#3
(114/146)
(70.7% to 84.0%)
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.
Positive Percent Agreement
ThinPrep 2000
(95% CI)
84.3%
(156/185)
(78.4% to 88.9%)
81.1%
(150/185)
(74.8% to 86.1%)
84.9%
(157/185)
(79.0% to 89.3%)
Positive Percent Agreement
ThinPrep 2000
(95% CI)
80.1%
(117/146)
(72.9% to 85.8%)
74.7%
(109/146)
(67.0% to 81.0%)
82.9%
(121/146)
(75.9% to 88.1%)
Difference
ThinPrep 5000
(95% CI)
(95% CI)
-2.7%
90.6%
(-5/185)
(943/1041)
(-8.6% to 3.2%)
(88.7% to 92.2%)
0.5%
91.7%
(1/185)
(955/1041)
(-6.0% to 7.1%)
(89.9% to 93.3%)
0.5%
89.8%
(1/185)
(935/1041)
(-5.4% to 6.5%)
(87.8% to 91.5%)
Difference
ThinPrep 5000
(95% CI)
(95% CI)
-2.7%
93.2%
(-4/146)
(1007/1080)
(-9.8% to 4.3%)
(91.6% to 94.6%)
-4.8%
94.3%
(-7/146)
(1018/1080)
(-11.8% to 2.3%)
(92.7% to 95.5%)
-4.8%
91.9%
(-7/146)
(992/1080)
(-12.6% to 3.1%)
(90.1% to 93.3%)
Negative Percent Agreement
ThinPrep 2000
(95% CI)
90.6%
(943/1041)
(88.7% to 92.2%)
91.1%
(948/1041)
(89.2% to 92.7%)
90.6%
(943/1041)
(88.7% to 92.2%)
Negative Percent Agreement
ThinPrep 2000
(95% CI)
93.2%
(1007/1080)
(91.6% to 94.6%)
94.7%
(1023/1080)
(93.2% to 95.9%)
92.3%
(997/1080)
(90.6% to 93.8%)
MAN-04008-001 Rev. 001
Difference
(95% CI)
0.0%
(0/1041)
(-1.6% to 1.6%)
0.7%
(7/1041)
(-1.0% to 2.3%)
-0.8%
(-8/1041)
(-2.5% to 0.9%)
Difference
(95% CI)
0.0%
(0/1080)
(-1.4% to 1.4%)
-0.5%
(-5/1080)
(-1.9% to 1.0%)
-0.5%
(-5/1080)
(-2.1% to 1.2%)
Page 19 of 27
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