MAN-08723-001 Rev. 001 page 8 of 28
Table 7: 6x6 “True AGUS” Contingency Table For All Sites Combined
All 10 Cases Determined To Be AGUS By Adjudication
Unadjudicated Manual Review Arm Diagnosis
NEG ASCUS AGUS LSIL HSIL CA TOTAL
NEG
-
2 1
-
1
-
4
ASCUS
-
-
1
-
-
-
1
AGUS 2
-
1
-
-
1 4
LSIL
-
-
-
-
-
-
0
HSIL
-
-
-
-
-
-
0
CA
-
-
-
-
-
1 1
TOTAL 2 2 3 0 1 2 10
Among the 10 cases determined by the adjudication panel to be AGUS, 4 (40.0%) cases in the
Imager Review arm and 3 (30.0%) cases in the Manual Review arm were diagnosed as AGUS and
4 (40.0%) cases in the Imager Review arm and 2 (20.0%) cases in the Manual Review arm were
diagnosed as Negative.
Table 8: 6x6 “True LSIL” Contingency Table For All Sites Combined
All 236 Cases Determined To Be LSIL By Adjudication
Unadjudicated Manual Review Arm Diagnosis
NEG ASCUS AGUS
LSIL
HSIL CA TOTAL
NEG
-
4
-
12 1
-
17
ASCUS 13 16
-
20 1
-
50
AGUS
-
-
-
-
-
-
0
LSIL 8 20
-
115 12
-
155
HSIL
-
-
-
5 9
-
14
CA
-
-
-
-
-
-
0
TOTAL 21 40 0 152 23 0 236
Among the 236 cases determined by the adjudication panel to be LSIL, 155 (65.6%) cases in the
Imager Review arm and 152 (64.4%) cases in the Manual Review arm were diagnosed as LSIL and
17 (7.2%) cases in the Imager Review arm and 21 (8.9%) cases in the Manual Review arm were
diagnosed as Negative.
Table 9: 6x6 “True HSIL” Contingency Table For All Sites Combined
All 138 Cases Determined To Be HSIL By Adjudication
Unadjudicated Manual Review Arm Diagnosis
NEG ASCUS AGUS LSIL HSIL CA TOTAL
NEG
-
1
-
-
1
-
2
ASCUS 2 4
-
2 1
-
9
AGUS
-
-
-
-
-
-
0
LSIL 1
-
-
10 6
-
17
HSIL 3 3 1 9 91 1 108
CA
-
-
-
-
1 1 2
TOTAL 6 8 1 21 100 2 138
Unadjudicated Imager
Review Arm Diagnosis
Unadjudicated Imager
Review Arm Diagnosis
Unadjudicated Imager
Review Arm Diagnosis
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