Hologic ThinPrep Operator's Manual page 14

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