Hologic ThinPrep Imager Duo Operator's Manual page 30

Table 29: Sensitivity and Specificity for Genesis TIS and Genesis Manual Review Results with
Genesis Diagnostic Threshold HSIL+
In the study, there were 170 specimens with Reference Diagnosis of HSIL+ (combined HSIL and Cancer) and 1,076
specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, LSIL, and ASC-H).
In this table, "Positive" means HSIL+ or UNSAT, and "Negative" means NILM, ASC-US/AGUS, LSIL, or ASC-H.
Review
Site Team N
1 1 63
(78.8%;94.5%)
2 1 49
(75.8%;94.3%)
3 1 58
(63.5%;85.0%)
Com- 1 170
bined
(143/170)
(77.9%;88.8%)
1 Genesis TIS - Genesis Manual.
Table 30: Sensitivity and Specificity for Genesis TIS and Genesis Manual Review Results with
Genesis Diagnostic Threshold of Cancer
In the study, there were 22 specimens with Reference Diagnosis of Cancer and 1,224 specimens with Reference
Diagnosis of (combined NILM, ASC-US/AGUS, LSIL, and ASC-H).
In this table, "Positive" means HSIL+ or UNSAT, and "Negative" means NILM, ASC-US/AGUS, LSIL, or ASC-H. All
percentages are rounded to the nearest 0.1%.
Review
Site Team N
1 1 9
(35.4%;87.9%)
2 1 6
(43.6%;97.0%)
3 1 7
(25.0%;84.2%)
Com-
1 22
bined
(47.3%;83.6%)
1
Genesis TIS - Genesis Manual.
Sensitivity, 95% CI)
TIS Manual
88.9% 87.3%
(56/63) (55/63)
(76.9%;93.4%)
87.8% 81.6%
(43/49) (40/49)
(68.6%;90.0%)
75.9% 63.8%
(44/58) (37/58)
(50.9%;74.9%)
84.1% 77.6%
(132/170)
(70.8%;83.3%)
Sensitivity, (95% CI)
TIS Manual
66.7% 77.8%
(6/9) (7/9)
(45.3%;93.7%)
83.3% 83.3%
(5/6) (5/6)
(43.6%;97.0%)
57.1% 42.9%
(4/7) (3/7)
(15.8%;75.0%)
68.2% 68.2%
(15/22) (15/22)
(47.3%;83.6%)
Difference 1 N
1.6% 351
(-7.9%;11.3%) (334/351)
(92.4%;97.0%)
6.1% 367
(-6.9%;19.3%) (353/367)
(93.7%;97.7%)
12.1% 358
(1.8%;22.2%) (347/358)
(94.6%;98.3%)
6.5% 1076
(0.6%;12.4%) (1034/1076)
(94.8%;97.1%)
1
Difference N
-11.1% 405
(-38.7%;18.2%) (399/405)
(96.8%;99.3%)
0.0% 410
(-36.4%;36.4%) (406/410)
(97.5%;99.6%)
14.3% 409
(-19.1%;42.4%) (406/409)
(97.9%;99.8%)
0.0% 1224
(-15.2%;15.2%) (1211/1224)
(98.2%;99.4%)
Specificity, 95% CI)
TIS Manual
95.2% 95.7%
(336/351)
(93.1%;97.4%)
96.2% 95.9%
(352/367)
(93.4%;97.5%)
96.9% 98.6%
(353/358)
(96.8%;99.4%)
96.1% 96.7%
(1041/1076)
(95.5%;97.7%)
Specificity, (95% CI)
TIS Manual
98.5% 98.5%
(399/405)
(96.8%;99.3%)
99.0% 98.8%
(405/410)
(97.2%;99.5%)
99.3% 99.3%
(406/409)
(97.9%;99.8%)
98.9% 98.9%
(1210/1224)
(98.1%;99.3%)
MAN-08723-001 Rev. 001 page 26 of 28
Difference 1
-0.6%
(-2.4%;1.1%)
0.3%
(-1.6%;2.2%)
-1.7%
(-3.9%;0.2%)
-0.7%
(-1.7%;0.3%)
1
Difference
0.0%
(-1.4%;1.4%)
0.2%
(-1.3%;1.9%)
0.0%
(-1.4%;1.4%)
0.1%
(-0.6%;0.8%)