Hologic ThinPrep - Page 14

MAN-05359-001 -001 Rev. 001 page 10 of 32
Table 6. ThinPrep Imaging System (TIS) Versus Integrated Imager (I2),
Descriptive Diagnosis Summary (ThinPrep 2000 System-processed Slides Only)
Sensitivity Specificity
Threshold
TIS
[# of reads]
(95% CI)
I2
[# of reads]
(95% CI)
Difference
[# of reads]
(95% CI)
TIS
[# of reads]
(95% CI)
I2
[# of reads]
(95% CI)
Difference
[# of reads]
(95% CI)
ASCUS+
85.7%
[1209/1411]
(83.8% to 87.4%)
90.0%
[1270/1411]
(88.3% to 1.5%)
4.3%
[61/1411]
(2.6% to 6.1%)
90.3%
[2006/2222]
(89.0% to 91.4%)
88.9%
[1975/2222]
(87.5% to 90.1%)
-1.4%
[-31/2222]
(-2.7% to -0.1%)
LSIL+
77.6%
[820/1057]
(75.0% to 80.0%)
84.3%
[891/1057]
(82.0% to 86.4%)
6.7%
[71/1057]
(4.3% to 9.1%)
92.7%
[2388/2576]
(91.6% to 93.6%)
91.3%
[2353/2576]
(90.2% to 92.4%)
-1.4%
[-35/2576]
(-2.3% to -0.4%)
ASC-H+
73.1%
[370/506]
(69.1% to 76.8%)
81.8%
[414/506]
(78.2% to 84.9%)
8.7%
[44/506]
(4.9% to 12.5%)
92.8%
[2903/3127]
(91.9% to 93.7%)
91.1%
[2849/3127]
(90.1% to 92.1%)
-1.7%
[-54/3127]
(-2.5% to -1.0%)
HSIL+
59.0%
[214/363]
(53.8% to 63.9%)
70.2%
[255/363]
(65.4% to 74.7%)
11.3%
[41/363]
(6.4% to 16.1%)
95.4%
[3118/3270]
(94.6% to 96.0%)
94.2%
[3081/3270]
(93.4% to 95.0%)
-1.1%
[-37/3270]
(-1.8% to -0.5%)
UNSAT
83.3%
[65/78]
(73.5% to 90.0%)
82.1%
[64/78]
(72.1% to 89.0%)
-1.3%
[1/78]
(-8.9% to 6.2%)
98.6%
[3647/3699]
(98.2% to 98.9%)
98.6%
[3649/3699]
(98.2% to 99.0%)
0.1%
[2/3699]
(-0.3% to 0.4%)
Table 7. ThinPrep Imaging System (TIS) Versus Integrated Imager (I2),
Descriptive Diagnosis Summary (ThinPrep 5000 Processor-processed Slides Only)
Sensitivity Specificity
Threshold
TIS
[# of reads]
(95% CI)
I2
[# of reads]
(95% CI)
Difference
[# of reads]
(95% CI)
TIS
[# of reads]
(95% CI)
I2
[# of reads]
(95% CI)
Difference
[# of reads]
(95% CI)
ASCUS+
86.4%
[1190/1377]
(84.5% to 88.1%)
89.6%
[1234/1377]
(87.9% to 91.1%)
3.2%
[44/1377]
(1.6% to 4.8%)
89.3%
[1989/2228]
(87.9% to 90.5%)
86.8%
[1935/2228]
(85.4% to 88.2%)
-2.4%
[-54/2228]
(-3.8% to -1.1%)
LSIL+
78.1%
[796/1019]
(75.5% to 80.5%)
83.0%
[846/1019]
(80.6% to 85.2%)
4.9%
[50/1019]
(2.5% to 7.3%)
92.2%
[2385/2586]
(91.1% to 93.2%)
89.9%
[2324/2586]
(88.6% to 91.0%)
-2.4%
[-61/2586]
(-3.4% to -1.4%)
ASC-H+
73.4%
[354/482]
(69.3% to 77.2%)
79.5%
[383/482]
(75.6% to 82.8%)
6.0%
[29/482]
(2.2% to 9.8%)
92.5%
[2888/3123]
(91.5% to 93.3%)
91.1%
[2845/3123]
(90.0% to 92.0%)
-1.4%
[-43/3123]
(-2.2% to -0.6%)
HSIL+
60.4%
[194/321]
(55.0% to 65.6%)
64.5%
[207/321]
(59.1% to 69.5%)
4.0%
[13/321]
(-0.6% to 8.6%)
94.9%
[3116/3284]
(94.1% to 95.6%)
93.8%
[3082/3284]
(93.0% to 94.6%)
-1.0%
[-34/3284]
(-1.7% to -0.3%)
UNSAT
73.9%
[51/69]
(62.5% to 82.8%)
72.5%
[50/69]
(61.0% to 81.6%)
-1.4%
[1/69]
(-11.3% to 8.4%)
98.2%
[3628/3696]
(97.7% to 98.5%)
98.2%
[3630/3696]
(97.7% to 98.6%)
0.1%
[2/3696]
(-0.3% to 0.4%)
Tables 8 through 14 show the performance of TIS review and Integrated Imager review compared to
adjudicated diagnosis made by the adjudication panel (truth, from previous study) for the following
major descriptive diagnosis classifications of the Bethesda System: NILM, ASCUS, LSIL, ASC-H,
AGUS, HSIL and Cancer.
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