Hologic ThinPrep 5000, Operator'S Manual

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ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 22/36
study, there were 22 Cancer, 124 HSIL, 39 ASC-H, 202 LSIL, 23 AGUS, 120 ASC-US, and 696
NILM specimens. Thirty-four (34) specimens had UNSAT either with ThinPrep 2000 or with
ThinPrep 5000 or with both. Clinical sensitivity and specificity (e.g., with reference to a
histological diagnosis) cannot be measured in this study which relied on cytological examination
alone. Instead, laboratory positive and negative diagnoses by both methods, ThinPrep 5000 and
ThinPrep 2000, for the specimens with Reference Diagnosis of ASC-US+ (combined ASC-US,
AGUS, LSIL, ASC-H, HSIL, and Cancer), LSIL+ (combined LSIL, ASC-H, HSIL, and Cancer), ASC-H+
(combined ASC-H, HSIL, and Cancer) and HSIL+ (combined HSIL and Cancer) were compared.
Clinical Study Results
Tables 20 through 23 present the comparison of Laboratory true positive and negative rates for
ASC-US+, LSIL+, ASC-H+, and HSIL+.
Table 20: Laboratory ThinPrep 5000 Results vs Laboratory ThinPrep 2000 Results
for the Specimens with Reference Diagnosis of ASC-US+
In the study, there were 530 specimens with Reference Diagnosis of ASC-US+ (combined
ASC-US, AGUS, LSIL, ASC-H, HSIL, and Cancer) and 696 specimens with Reference
Diagnosis of NILM.
In this table, “Positive” means ASC-US+ or UNSAT, and “Negative” means NILM. All
percentages are rounded to the nearest 0.1%.
ASC-US+
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
90.9%
(482/530)
(88.2% to 93.1%)
89.4%
(474/530)
(86.5% to 91.8%)
1.5%
(8/530)
(-0.7% to 3.8%)
89.1%
(620/696)
(86.5% to 91.2%)
87.9%
(612/696)
(85.3% to 90.1%)
1.1%
(8/696)
(-1.1% to 3.5%)
#2
87.0%
(461/530)
(83.8% to 89.6%)
86.6%
(459/530)
(83.4% to 89.2%)
0.4%
(2/530)
(-2.7% to 3.4%)
88.6%
(617/696)
(86.1% to 90.8%)
90.7%
(631/696)
(88.3% to 92.6%)
-2.0%
(-14/696)
(-4.4% to 0.3%)
#3
87.5%
(464/530)
(84.5% to 90.1%)
88.5%
(469/530)
(85.5% to 90.9%)
-0.9%
(-5/530)
(-3.7% to 1.8%)
87.6%
(610/696)
(85.0% to 89.9%)
88.1%
(613/696)
(85.5% to 90.3%)
-0.4%
(-3/696)
(-2.9% to 2.0%)