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