MAN-05359-001 -001 Rev. 001 page 6 of 32
Table 2. Manual Review Versus Imager Review, Descriptive Diagnosis Summary
Sensitivity Specificity
Threshold
Manual
(95% CI)
Imager
(95% CI)
Difference
(95% CI)
Manual
(95% CI)
Imager
(95% CI)
Difference
(95% CI)
ASCUS+
75.6%
(72.2% to 78.8%)
82.0%
(78.8% to 84.8%)
+6.4%
(2.6% to 10.0%)
97.6%
(97.2% to 97.9%)
97.8%
(97.4% to 98.1%)
+0.2%
(-0.2% to 0.6%)
LSIL+
79.7%
(75.3% to 83.7%)
79.2%
(74.7% to 83.2%)
-0.5%
(-5.0 % to 4.0%)
99.0%
(98.8% to 99.2%)
99.1%
(98.9% to 99.3%)
+0.09%
(-0.1% to 0.3%)
HSIL+
74.1%
(66.0% to 81.2%)
79.9%
(72.2% to 86.2%)
+5.8%
(-1.1% to 12.6%)
99.4 %
(99.2% to 99.6%)
99.6%
(99.5% to 99.7%)
+0.2%
(0.06% to 0.4%)
UNSAT
29.3%
(18.1% to 42.7%)
13.8%
(6.1% to 25.4%)
-15.5%
(-25.9% to 5.0%)
99.5%
(99.3% to 99.6%)
99.8%
(99.7% to 99.9%)
+0.3%
(0.2% to 0.4%)
The results presented in Table 2 show that for ASCUS+, the increase in sensitivity of the Imager
Review over the Manual Review was statistically significant with the lower limit of the 95%
confidence interval being 2.6% for all sites combined. The observed difference between
sensitivities for ASCUS+ varied among the sites from –2.8% with a 95% confidence interval of
(–10.6%; 5.0%) to +14.4% with a 95% confidence interval of (8.2%; 20.5%). The difference in
specificity results between the Imager Review and the Manual Review was not statistically
significant with a 95% confidence interval of –0.2% to +0.6%. The observed differences
between specificities varied among the sites from –0.3% to +0.4%.
The results presented in Table 2 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%.
The results presented in Table 2 show that the difference between sensitivities of the Imager
Review and Manual Review arms for HSIL+ for all sites combined was not statistically
significant with a 95% confidence interval of –1.1% to +12.6%. The observed difference
between sensitivities for HSIL+ varied among the sites from –2.5% with a 95% confidence
interval of (–15.4%; 10.4%) to +13.6% with a 95% confidence interval of (–0.7%; 28.0%). The
increase in specificity of the Imager Review over the Manual Review was statistically significant
with a 95% confidence interval of +0.06% to +0.4%. The observed differences between
specificities varied among the sites from –0.1% to +0.7%.
Table 3 shows the unadjudicated marginal frequencies data for benign cellular changes for all
sites combined.
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