ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 13/36
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.