MAN-04008-001 Rev. 001 Page 8 of 27
NEG ASCUS/AGUS+ TOTAL
NEG
5224 369 5593
ASCUS
AGUS+
456 698 1154
TOTAL
5680 1067 6747
Table 5: Two Category Diagnostic Classification Table,
ASCUS/AGUS and More Severe Diagnoses
Conventional
ThinPrep
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+
Con
ent.
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.
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