Hologic ThinPrep Imager Duo - Page 11

MAN-08723-001 Rev. 001 page 7 of 28
The results presented in Table 4 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%.
Tables 5-9 show the performance of the Imager Review and Manual Review compared to the final
consensus diagnosis made by the adjudication panel (truth) for the following major descriptive
diagnosis classifications of the Bethesda System: Negative, ASCUS, AGUS, LSIL, HSIL, Cancer*
(CA)
*Includes SQ CA and GL CA.
Abbreviations for Diagnoses: NEG = Normal or negative, ASCUS = Atypical Squamous Cells of Undetermined Significance,
AGUS = Atypical Glandular Cells of Undetermined Significance, LSIL = Low-grade Squamous Intraepithelial Lesion, HSIL
= High-grade Squamous Intraepithelial Lesion, SQ CA = Squamous Cell Carcinoma, GL CA
= Glandular Cell Adenocarcinoma.
Table 5: 6x6 “True Negative” Contingency Table For All Sites Combined
All 786 Cases Determined To Be Negative By Adjudication
Unadjudicated Manual Review Arm Diagnosis
NEG ASCUS AGUS LSIL HSIL CA TOTAL
NEG 425 138 6 10 6 2 587
ASCUS 130 39 1 3 - - 173
AGUS 5 - - - - - 5
LSIL 9 5 - 2 - - 16
HSIL 1 1 - - 3 - 5
CA - - - - - - 0
TOTAL 570 183 7 15 9 2 786
Among the 786 cases determined by the adjudication panel to be Negative, 587 (74.7%) cases in the
Imager Review arm and 570 (72.5%) cases in the Manual Review arm were diagnosed as Negative
and 21 (2.7%) cases in the Imager Review arm and 26 (3.3%) cases in the Manual Review arm were
diagnosed as LSIL+.
Table 6: 6x6 “True ASCUS” Contingency Table For All Sites Combined
All 251 Cases Determined To Be ASCUS By Adjudication
Unadjudicated Manual Review Arm Diagnosis
NEG ASCUS AGUS LSIL HSIL CA TOTAL
NEG 3 32 - 7 3 - 45
ASCUS 70 47 1 20 4 - 142
AGUS 1 - - - - - 1
LSIL 6 21 - 16 7 - 50
HSIL 2 3 - 5 1 1 12
CA 1 - - - - - 1
TOTAL 83 103 1 48 15 1 251
Among the 251 cases determined by the adjudication panel to be ASCUS, 142 (56.6%) cases in the
Imager Review arm and 103 (41.0%) cases in the Manual Review arm were diagnosed as ASCUS
and 45 (17.9%) cases in the Imager Review arm and 83 (33.1%) cases in the Manual Review arm
were diagnosed as Negative.
Unadjudicated Imager
Review Arm Diagnosis
Unadjudicated Imager
Review Arm Diagnosis