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Hologic ThinPrep 5000 Instruction Manual page 10

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Table 8: Independent Pathologist Results by Site, LSIL and More Severe Lesions
 
 
Cases
Site
Positive by
Independent
Pathologist
 
 
S1
 
 
S2
 
 
S3
 
 
H1
116
 
 
H2
115
 
 
H3
126
 
 
For LSIL and more severe lesions, the diagnostic comparison statistically favored the
ThinPrep method at three sites and was statistically equivalent at three sites.
 
 
 
 
Table 9: Independent Pathologist Results by Site,
 
 
Cases
Site
Positive by
Independent
Pathologist
S1
101
S2
109
S3
170
H1
H2
171
204
H3
 
 
For ASCUS/AGUS and more severe lesions, the diagnostic comparison statistically favored
the ThinPrep method at two sites and was statistically equivalent at four sites.
 
 
ThinPrep
Positive
 
50
33
 
65
48
 
77
54
 
102
 
86
 
120
ASCUS/AGUS and More Severe Lesions
 
®
ThinPrep
Positive
92
72
85
95
155
143
190
 
Conventional
p-Value
Positive
25
0.170
33
0.042
33
<0.001
81
<0.001
90
0.876
112
0.170
 
Conventional
p-Value
Positive
68
0.900
59
0.005
65
<0.001
143
0.237
154
0.330
191
1.000
MAN-04008-001 Rev. 001
 
Method
Favored
 
Neither
 
ThinPrep
 
ThinPrep
 
ThinPrep
 
Neither
 
Neither
 
Method
Favored
Neither
ThinPrep
ThinPrep
Neither
Neither
Neither
Page 10 of 27

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