ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 23/36
Table 21: Laboratory ThinPrep 5000 Results vs Laboratory ThinPrep 2000 Results
for the Specimens with Reference Diagnosis of LSIL+
In the study, there were 387 specimens with Reference Diagnosis of LSIL+ (combined LSIL,
ASC-H, HSIL, and Cancer) and 839 specimens with Reference Diagnosis of (combined
NILM, ASC-US, and AGUS).
In this table, “Positive” means LSIL+ or UNSAT, and “Negative” means NILM or ASC-
US/AGUS. All percentages are rounded to the nearest 0.1%.
LSIL+
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
84.8%
(328/387)
(80.8% to 88.0%)
86.8%
(336/387)
(83.1% to 89.8%)
-2.1%
(-8/387)
(-5.9% to 1.7%)
90.3%
(758/839)
(88.2% to 92.2%)
89.5%
(751/839)
(87.3% to 91.4%)
0.8%
(7/839)
(-1.1% to 2.8%)
#2
84.0%
(325/387)
(80.0% to 87.3%)
83.5%
(323/387)
(79.4% to 86.8%)
0.5%
(2/387)
(-3.6% to 4.6%)
91.7%
(769/839)
(89.6% to 93.3%)
91.4%
(767/839)
(89.3% to 93.1%)
0.2%
(2/839)
(-1.7% to 2.2%)
#3
84.0%
(325/387)
(80.0% to 87.3%)
87.3%
(338/387)
(83.7% to 90.3%)
-3.4%
(-13/387)
(-7.4% to 0.6%)
88.6%
(743/839)
(86.2% to 90.5%)
89.4%
(750/839)
(87.1% to 91.3%)
-0.8%
(-7/839)
(-2.9% to 1.2%)
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