Hologic ThinPrep Imager Duo Operator's Manual page 29

Table 27: Sensitivity and Specificity for Genesis TIS and Genesis Manual Review Results with
Genesis Diagnostic Threshold LSIL+
In the study, there were 402 specimens with Reference Diagnosis of LSIL+ (combined LSIL, ASC-H, HSIL, and Cancer)
and 844 specimens with Reference Diagnosis of (combined NILM, ASC-US, and AGUS).
In this table, "Positive" means LSIL+ or UNSAT, and "Negative" means NILM or ASC-US/AGUS.
Review
Site Team N
1 1 143
(110/143)
(69.4%;83.1%)
2 1 116
(77.8%;90.6%)
3 1 143
(115/143)
(73.2%;86.1%)
Com- 1 402
bined
(324/402)
(76.4%;84.2%)
1 Genesis TIS - Genesis Manual.
Table 28: Sensitivity and Specificity for Genesis TIS and Genesis Manual Review Results with
Genesis Diagnostic Threshold ASC-H+
In the study, there were 202 specimens with Reference Diagnosis of ASC-H+ (combined ASC-H, HSIL, and Cancer) and
1,044 specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, and LSIL).
In this table, "Positive" means ASC-H+ or UNSAT, and "Negative" means NILM, ASC-US/AGUS, or LSIL.
Review
Site Team N
1 1 78
(79.5%;93.8%)
2 1 57
(76.8%;93.9%)
3 1 67
(76.4%;92.8%)
Com- 1 202
bined
(177/202)
(82.4%;91.5%)
1 Genesis TIS - Genesis Manual.
Sensitivity, 95% CI)
TIS Manual
76.9% 79.0%
(113/143)
(71.6%;84.9%)
85.3% 87.9%
(99/116) (102/116)
(80.8%;92.7%)
80.4% 63.6%
(91/143)
(55.5%;71.1%)
80.6% 76.1%
(306/402)
(71.7%;80.0%)
Sensitivity, 95% CI)
TIS Manual
88.5% 84.6%
(69/78) (66/78)
(75.0%;91.0%)
87.7% 82.5%
(50/57) (47/57)
(70.6%;90.2%)
86.6% 73.1%
(58/67) (49/67)
(61.5%;82.3%)
87.6% 80.2%
(162/202)
(74.2%;85.1%)
Difference 1 N
-2.1% 271
(-7.7%;3.5%) (253/271)
(89.7%;95.8%)
-2.6% 300
(-8.4%;3.0%) (281/300)
(90.3%;95.9%)
16.8% 273
(9.9%;23.6%) (256/273)
(90.3%;96.1%)
4.5% 844
(0.9%;8.0%) (790/844)
(91.7%;95.1%)
1
Difference N
3.8% 336
(-3.6%;11.7%) (319/336)
(92.0%;96.8%)
5.3% 359
(-6.0%;16.7%) (336/359)
(90.6%;95.7%)
13.4% 349
(4.8%;22.8%) (330/349)
(91.7%;96.5%)
7.4% 1044
(2.6%;12.5%) (985/1044)
(92.8%;95.6%)
Specificity, 95% CI)
TIS Manual
93.4% 93.7%
(254/271)
(90.2%;96.0%)
93.7% 93.3%
(280/300)
(89.9%;95.6%)
93.8% 96.7%
(264/273)
(93.9%;98.3%)
93.6% 94.5%
(798/844)
(92.8%;95.9%)
Specificity, 95% CI)
TIS Manual
94.9% 94.3%
(317/336)
(91.3%;96.4%)
93.6% 93.0%
(334/359)
(89.9%;95.2%)
94.6% 97.4%
(340/349)
(95.2%;98.6%)
94.3% 94.9%
(991/1044)
(93.4%;96.1%)
MAN-08723-001 Rev. 001 page 25 of 28
Difference 1
-0.4%
(-3.2%;2.4%)
0.3%
(-2.3%;3.0%)
-2.9%
(-6.0%;-0.3%)
-0.9%
(-2.4%;0.5%)
1
Difference
0.6%
(-1.5%;2.8%)
0.6%
(-1.8%;3.0%)
-2.9%
(-5.4%;-0.7%)
-0.6%
(-1.8%;0.7%)