Hologic ThinPrep, Operator'S Manual

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