Hologic ThinPrep Operator's Manual page 11

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
NEG
ASCUS
AGUS
LSIL
HSIL
CA
TOTAL
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
NEG
ASCUS
AGUS
LSIL
HSIL
CA
TOTAL
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 Manual Review Arm Diagnosis
NEG ASCUS AGUS
425 138 6
130 39 1
5 - -
9 5 -
1 1 -
- - -
570 183 7
Unadjudicated Manual Review Arm Diagnosis
NEG ASCUS AGUS
3 32 -
70 47 1
1 - -
6 21 -
2 3 -
1 - -
83 103 1
LSIL HSIL CA TOTAL
10 6 2
3 - -
- - -
2 - -
- 3 -
- - -
15 9 2
LSIL HSIL CA TOTAL
7 3 -
20 4 -
- - -
16 7 -
5 1 1
- - -
48 15 1
MAN-03938-001 Rev. 002 page 7 of 23
587
173
5
16
5
0
786
45
142
1
50
12
1
251