ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 24/36
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%)
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