Hologic thinprep 2000 - Results by Site, LSIL and more Severe Lesions; Results by Site, ASCUS;AGUS and more Severe Lesions

MAN-02624-001 Rev. 003 page 8 of 15
The diagnostic data analysis from the sites is summarized in Table 6 and 7. When the p-value is significant (p <
0.05), the method favored is indicated in the tables.
Table 6: Results by Site, LSIL and More Severe Lesions
Site Cases ThinPrep
LSIL+
Convent.
LSIL+
Increased
Detection*
p-Value Method
Favored
S1
1,336 46 31 48% 0.027 ThinPrep
S2
1,563 78 45 73% <0.001 ThipPrep
S3
1,058 67 40 68% <0.001 ThinPrep
H1
971 125 96 30% <0.001 ThinPrep
H2
1,010 111 130 (15%) 0.135 Neither
H3
809 210 196 7% 0.374 Neither
*Increased detection = ThinPrep
®
LSIL+ - Conventional LSIL+ x 100%
Conventional LSIL+
For LSIL and more severe lesions, the diagnostic comparison statistically
favored the ThinPrep
®
method at four sites and was statistically equivalent at
two sites.
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.