Hologic ThinPrep 5000, Operator'S Manual

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ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 25/36
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.