Hologic thinprep 2000, Instructions For Use Manual

Page: 8 / 14

MAN-02060-001 Rev. 005 page 8 of 14
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.
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.