Hologic ThinPrep 5000, Operator'S Manual, Page: 17 / 346

ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 11/36
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.