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