Lsil - Hologic ThinPrep 5000 Instruction Manual

Table 7: Results by Site, ASCUS/AGUS and More Severe Lesions
Site Cases
S1 1,336
S2 1,563
S3 1,058
971
H1
H2 1,010
809
H3
*Increased detection = ThinPrep ASCUS+ - Conventional ASCUS+ x 100%
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.
ThinPrep
Convent.
ASCUS+ ASCUS+
117 93
124 80
123 81
204 173
259 282
327 359
Conventional ASCUS+
Increased
p-Value
Detection*
26% 0.067
55% <0.001
52% <0.001
18% 0.007
(8%) 0.360
(9%) 0.102
MAN-04008-001 Rev. 001
Method
Favored
Neither
ThinPrep
ThinPrep
ThinPrep
Neither
Neither
Page 9 of 27