MAN-05359-001 -001 Rev. 001 page 13 of 32
Table 14. “True Cancer” Contingency Table (for All Sites Combined)
Overall Adjudicated Cancer
TIS vs. I2
TIS
UNSAT NILM ASCUS LSIL ASC-H AGUS HSIL Cancer
I2
UNSAT
0 0 0 0 0 0 0 0
NILM
0 0 0 0 0 0 0 0
ASCUS
0 0 0 0 1 0 0 0
LSIL
0 0 1 0 0 0 0 0
ASC-H
0 0 1 1 2 0 0 0
AGUS
0 0 0 1 0 6 0 8
HSIL
0 0 0 0 1 0 19 1
Cancer
0 0 0 0 0 4 5 63
Table 15 shows the descriptive diagnosis marginal frequencies for benign cellular changes for
all sites combined. Each slide was read three times, first by a cytotechnologist and then by a
pathologist.
Table 15. Unadjudicated Marginal Frequencies –
Summary of Descriptive Diagnosis for Benign Cellular Changes –
All Sites Combined
TIS Review I2 Review
Number of Reads
7542 7542
Descriptive Diagnosis N % N %
Benign Cellular Changes 402 5.3% 420 5.6%
Organisms:
Trichomonas vaginalis
20 0.3% 28 0.4%
Fungal organisms consistent with Candida spp.
122 1.6% 128 1.7%
Shift in Flora s/o bacterial vaginosis
183 2.4% 208 2.8%
Bacteria consistent with Actinomyces spp.
2 0.0% 3 0.0%
Cellular changes consistent with Herpes virus
2 0.0% 1 0.0%
Other infection
0 0.0% 0 0.0%
Other Non-Neoplastic Findings
0.0%
Reactive cellular changes assoc. w/ inflammation
34 0.5% 16 0.2%
Atrophy
33 0.4% 26 0.3%
Reactive cellular changes assoc. w/ radiation
0 0.0% 0 0.0%
Reactive cellular changes assoc. w/ IUD
0 0.0% 1 0.0%
Glandular cells status post hysterectomy
0 0.0% 0 0.0%
Endometrial cells in a woman ≥ 45 yrs of age
6 0.1% 9 0.1%
The Integrated Imager showed a slightly higher rate of Benign Cellular Changes (420 out of
7542, or 5.6%) than TIS Review (402 out of 7542, or 5.3%), however this was not statistically
significant.
Conclusion
The sensitivity and specificity of Integrated Imager for review of ThinPrep 2000 slides and
ThinPrep 5000 slides are similar to the sensitivity and specificity of the ThinPrep Imaging
System.
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