MAN-04008-001 Rev. 001 Page 9 of 27
Table 7: Results by Site, ASCUS/AGUS and More Severe Lesions
Site
Cases
ThinPrep
ASCUS+
Convent.
ASCUS+
Increased
Detection*
p-Value
Method
Favored
S1
1,336 117 93 26% 0.067 Neither
S2
1,563 124 80 55% <0.001 ThinPrep
S3
1,058 123 81 52% <0.001 ThinPrep
H1
971 204 173 18% 0.007 ThinPrep
H2
1,010 259 282 (8%) 0.360 Neither
H3
809 327 359 (9%) 0.102 Neither
*Increased detection = ThinPrep ASCUS+ - Conventional ASCUS+ x 100%
Conventional ASCUS+
For ASCUS/AGUS and more severe lesions, the diagnostic comparison statistically favored
the ThinPrep method at three sites and was statistically equivalent at three sites.
One pathologist served as an independent reviewer for the six clinical sites, receiving both
slides from cases where the two methods were either abnormal or discrepant. Since a true
reference cannot be determined in such studies and therefore true sensitivity cannot be
calculated, the use of an expert cytologic review provides an alternative to histologic
confirmation by biopsy or human papillomavirus (HPV) testing as a means for determining
the reference diagnosis.
The reference diagnosis was the more severe diagnosis from either of the ThinPrep or
conventional Pap slides as determined by the independent pathologist. The number of slides
diagnosed as abnormal at each site, compared to the reference diagnosis of the independent
pathologist, provides the proportion of LSIL or more severe lesions (Table 8) and the
proportion of ASCUS/AGUS or more severe lesions (Table 9). The statistical analysis allows a
comparison of the two methods and a determination of which method is favored when using
the independent pathologist for expert cytologic review as the adjudicator of the final
diagnosis.
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