Hologic ThinPrep Operator's Manual page 10

Table 3: Adjudicated Review Versus Imager Review LSIL+ Descriptive Diagnosis
Summary for Each Site and All Sites Combined.
Sensitivity is a percent of "true" LSIL+ (combined LSIL, HSIL, SQ CA and GL CA) slides classified in either study
arm as LSIL+ and specificity is a percent of "true" Non-LSIL+ (combined Negative, ASCUS, AGUS) slides classified
in either study arm as Non-LSIL+.
Sensitivity
Site/
Number Manual
Cases
84.6%
Site 1
104
(76.2, 90.9)
70.4%
Site 2
98
(60.3, 79.2)
77.4%
Site 3
62
(65.0, 87.1)
84.7%
Site 4
111
(98.1, 99.1)
79.7%
All
375
(75.3, 83.7)
Numbers in parentheses represent 95% confidence intervals.
The results presented in Table 3 show that the difference between sensitivities of the Imager Review
and Manual Review arms for LSIL+ for all sites combined was not statistically significant with a
95% confidence interval of –5.0% to +4.0%. The observed difference between sensitivities for
LSIL+ varied among the sites from –6.3% with a 95% confidence interval of (–14.7%; 2.1%) to
+8.1% with a 95% confidence interval of (–4.0%; 20.1%). The difference in specificity results
between the Imager Review and the Manual Review was not statistically significant with a 95%
confidence interval of -0.1% to +0.3%. The observed differences between specificities varied among
the sites from –0.4% to +0.6%.
Table 4: Adjudicated Review Versus Imager Review HSIL+ Descriptive Diagnosis
Summary for Each Site and All Sites Combined.
Sensitivity is a percent of "true" HSIL+ (combined HSIL, SQ CA and GL CA) slides classified in either study arm as
HSIL+ and specificity is a percent of "true" Non-HSIL+ (combined Negative, ASCUS, AGUS, LSIL) slides classified
in either study arm as Non-HSIL+.
Sensitivity
Site/
Number Manual
Cases
89.5%
Site 1
38
(75.2, 97.1)
72.5%
Site 2
40
(56.1, 85.4)
72.7%
Site 3
22
(49.8, 89.3)
61.5%
Site 4
39 (44.6, 76.6)
74.1%
All
139 (66.0, 81.2)
Numbers in parentheses represent 95% confidence intervals.
Site/
Imager Difference Number
Cases
82.7% -1.9%
Site 1
2208
(74.0, 89.4) (-9.5, 5.6)
72.4% +2.0%
Site 2
2342
(62.5, 81.0) (-6.9, 11.0)
85.5% +8.1%
Site 3
2237
(74.2, 93.1) (-4.0, 20.1)
78.4% -6.3%
Site 4
2381
(76.6, 90.8) (-14.7, 2.1)
79.2% -0.5%
All
9168
(74.7, 83.2) (-5.0, 4.0)
Site/
Imager Difference Number
Cases
92.1% 2.6%
Site 1
2274
(78.6, 98.3) (-8.9, 14.1)
70.0% -2.5%
Site 2
2400
(53.4, 83.4) (-15.4, 10.4)
86.4% +13.6%
Site 3
2277
(65.1, 97.1) (-0.7, 28.0)
74.4% +12.8%
Site 4
(57.9, 87.0) (-1.7, 27.4) 2453
79.9% +5.8%
All
(72.2, 86.2) (-1.1, 12.6) 9404
Specificity
Manual Imager Difference
98.7%
99.3% +0.6%
(98.9, 99.6) (0.1, 1.0)
(98.1, 99.1)
99.3% 98.9% -0.4%
(98.8, 99.6) (98.4, 99.3) (-0.8, .001)
99.2% 99.5% +0.3%
(98.7, 99.5) (99.1, 99.8) (-0.1, 0.6)
98.7% 98.7% -0.08%
(98.2, .99.2) (98.1, 99.1) (-0.6, 0.4)
99.0% 99.1% +0.09%
(98.8, 99.2) (98.9, 99.3) (-0.1, 0.3)
Specificity
Manual Imager Difference
98.8% 99.5% +0.7%
(98.3, 99.2) (99.1, 99.8) (0.2, 1.2)
99.8% 99.6% -0.1%
(99.5, 99.9) (99.2, 99.8) (-0.3, .09)
99.7% 99.7% 0%
(99.4, 99.9) (99.4, 99.9) (-0.2, 0.2)
99.5% 99.8% +0.3%
(99.2, 99.8) (99.5, 99.9) (-0.003, 0.6)
99.4 % 99.6% +0.2%
(99.2, 99.6) (99.5, 99.7) (0.06, 0.4)
MAN-03938-001 Rev. 002 page 6 of 23