Hologic ThinPrep - Page 13

MAN-05359-001 -001 Rev. 001 page 9 of 32
modality) and to compare with the ThinPrep Imaging System (TIS). The reference standard for
the slides in this study was pathologist adjudication consensus diagnosis from a previous study
2
.
G.2.2 Descriptive Diagnosis Sensitivity and Specificity Estimates
Abbreviations for Diagnostic Thresholds:
Category Partitions
Threshold Negative Positive
ASCUS+ NILM
ASCUS, LSIL, ASC–H, AGUS, HSIL,
Cancer
LSIL+ NILM, ASCUS LSIL, ASC–H, AGUS, HSIL, Cancer
ASC–H+ NILM, ASCUS, LSIL ASC–H, AGUS, HSIL, Cancer
HSIL+
NILM, ASCUS, LSIL, ASC–H,
AGUS
HSIL, Cancer
The study results are presented in Table 5. In all abnormal categories, the sensitivity for the
Integrated Imager was higher than the ThinPrep Imaging System across all thresholds listed in
Table 5. There was a slight decrease in specificity for the Integrated Imager as compared to the
ThinPrep Imaging System.
Table 5. ThinPrep Imaging System (TIS) Versus Integrated Imager,
Descriptive Diagnosis Summary (All Slides)
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Sensitivity Specificity
Threshold
TIS
(95% CI)
Integrated
Imager
(95% CI)
Difference
(95% CI)
TIS
(95% CI)
Integrated
Imager
(95% CI)
Difference
(95% CI)
ASCUS+
86.0%
(84.7% to 87.3%)
89.8%
(88.6% to 90.9%)
3.8%
(2.6% to 5.0%)
89.8%
(88.9% to 90.6%)
87.9%
(86.9% to 88.8%)
-1.9%
(-2.8% to -1.0%)
LSIL+
77.8%
(76.0% to 79.6%)
83.7%
(82.0% to 85.2%)
5.8%
(4.1% to 7.5%)
92.5%
(91.7% to 93.2%)
90.6%
(89.8% to 91.4%)
-1.9%
(-2.6% to -1.2%)
ASC-H+
73.3%
(70.4% to 75.9%)
80.7%
(78.1% to 83.0%)
7.4%
(4.7% to 10.1%)
92.7%
(92.0% to 93.3%)
91.1%
(90.4% to 91.8%)
-1.6%
(-2.1% to -1.0%)
HSIL+
59.6%
(55.9% to 63.3%)
67.5%
(63.9% to 70.9%)
7.9%
(4.5% to 11.2%)
95.1%
(94.6% to 95.6%)
94.0%
(93.4% to 94.6%)
-1.1%
(-1.6% to -0.6%)
UNSAT
78.9%
(71.6% to 84.7%)
77.6%
(70.2% to 83.5%)
-1.4%
(-7.3% to 4.5%)
98.4%
(98.1% to 98.6%)
98.4%
(98.1% to 98.7%)
0.1%
(-0.2% to 0.3%)
In addition, the data is presented below stratified by the type of processor used (ThinPrep 2000
System and ThinPrep 5000 processor). In all abnormal cases, the sensitivity for the Integrated
Imager was higher than the ThinPrep Imaging System across all thresholds. There was a slight
decrease in specificity for the Integrated Imager as compared to the ThinPrep Imaging System.
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