Hologic ThinPrep Imager Duo Operator's Manual page 28

LSIL, 5 AGUS, 148 ASC-US, 691 NILM, and 5 UNSAT specimens. Clinical sensitivity and
specificity (e.g., with reference to a histological diagnosis) cannot be measured in this study which
relied on cytological examination alone. Instead, laboratory positive and negative diagnoses by both
methods, Imager-assisted and manual review, for the specimens with Reference Diagnosis of ASC-
US+ (combined ASC-US, AGUS, LSIL, ASC-H, HSIL, and Cancer), LSIL+ (combined LSIL,
ASC-H, HSIL, and Cancer), ASC-H+ (combined ASC-H, HSIL, and Cancer), HSIL+ (combined
HSIL and Cancer) and Cancer were compared.
Clinical Study Results
Tables 26 through 31 present the comparison of Laboratory true positive and negative rates for
ASC-US+, LSIL+, ASC-H+, HSIL+ and Cancer for the first pair of cytotechnologist/pathologist
at each site and combined for the three sites for the first pair of cytotechnologist/pathologist data.
Table 26: Sensitivity and Specificity for Genesis TIS and Genesis Manual Review Results with
Genesis Diagnostic Threshold ASCUS+
In the study, there were 556 specimens with Reference Diagnosis of ASC-US+ (combined ASC-US, AGUS, LSIL, ASC-H,
HSIL, and Cancer) and 690 specimens with Reference Diagnosis of NILM.
In this table, "Positive" means ASC-US+ or UNSAT, and "Negative" means NILM.
Review
Site Team N
1 1 196
(150/196)
(70.1%;81.9%)
2 1 167
(122/167)
(65.9%;79.2%)
3 1 193
(157/193)
(75.3%;86.2%)
Com- 1 556
bined
(429/556)
(73.5%;80.5%)
1 Genesis TIS - Genesis Manual.
Sensitivity, (95% CI)
TIS Manual
76.5% 81.6%
(160/196)
(75.6%;86.4%)
73.1% 77.2%
(129/167)
(70.3%;82.9%)
81.3% 73.6%
(142/193)
(66.9%;79.3%)
77.2% 77.5%
(431/556)
(73.9%;80.8%)
Difference 1 N
-5.1% 218 93.6%
(-10.2%;- (204/218)
0.1%)
(89.5%;96.1%)
-4.2% 249 90.4%
(-8.7%;0.2%) (225/249)
(86.1%;93.4%)
7.8% 223 91.9%
(2.9%;12.8%) (205/223)
(87.6%;94.8%)
-0.4% 690 91.9%
(-3.1%;2.4%) (634/690)
(89.6%;93.7%)
Specificity, (95% CI)
TIS Manual
92.7%
(202/218)
(88.4%;95.4%)
88.0%
(219/249)
(83.3%;91.4%)
96.4%
(215/223) (-8.7%;-0.7%)
(93.1%;98.2%)
92.2%
(636/690)
(89.9%;94.0%)
MAN-08723-001 Rev. 001 page 24 of 28
Difference 1
0.9%
(-2.6%;4.5%)
2.4%
(-1.8%;6.7%)
-4.5%
-0.3%
(-2.5%;1.9%)