Ascus - Hologic ThinPrep 5000 Instruction Manual

Table 5: Two Category Diagnostic Classification Table,
ThinPrep

ASCUS/

AGUS+
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
1,336
S1
S2 1,563
S3 1,058
H1 971
H2 1,010
H3 809
*Increased detection = ThinPrep
For LSIL and more severe lesions, the diagnostic comparison statistically favored the
®
ThinPrep method at four sites and was statistically equivalent at two sites.
ASCUS/AGUS and More Severe Diagnoses
Conventional
NEG
NEG 5224
456
TOTAL
5680
ThinPrep Convent.
LSIL+ LSIL+
46 31
78 45
67 40
125 96
111 130
210 196
®
LSIL+ - Conventional LSIL+ x 100%
Conventional LSIL+
ASCUS/AGUS+
369
698
1067
Increased
p-Value
Detection*
48% 0.027
73% <0.001
68% <0.001
30% <0.001
(15%) 0.135
7% 0.374
MAN-04008-001 Rev. 001
TOTAL
5593
1154
6747
Method
Favored
ThinPrep
ThipPrep
ThinPrep
ThinPrep
Neither
Neither
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