MAN-02060-001 Rev. 005 page 9 of 14
Table 10 below shows the summary for all sites of the descriptive diagnosis for all Bethesda System categories.
Table 10: Summary of Descriptive Diagnosis
Descriptive Diagnosis
ThinPrep
Conventional
Number of Patients: 6747
N % N %
Benign Cellular Changes:
Infection:
Trichomonas Vaginalis
Candida spp.
Coccobacilli
Actinomyces spp.
Herpes
Other
Reactive Cellular Changes
Associated with:
Inflammation
Atrophic Vaginitis
Radiation
Other
1592
136
406
690
2
3
155
353
32
2
25
23.6
2.0
6.0
10.2
0.0
0.0
2.3
5.2
0.5
0.0
0.4
1591
185
259
608
3
8
285
385
48
1
37
23.6
2.7
3.8
9.0
0.0
0.1
4.2
5.7
0.7
0.0
0.5
Epithelial Cell Abnormalities:
Squamous Cell:
ASCUS
favor reactive
favor neoplastic
undetermined
LSIL
HSIL
Carcinoma
Glandular Cell:
Benign Endometrial cells in
Postmenopausal Women
Atypical Glandular Cells (AGUS)
favor reactive
favor neoplastic
undetermined
Endocervical Adenocarcinoma
1159
501
128
161
213
469
167
1
7
21
9
0
12
0
17.2
7.4
1.9
2.4
3.2
7.0
2.5
0.0
0.1
0.3
0.1
0.0
0.2
0.0
1077
521
131
140
250
367
167
3
10
9
4
3
2
1
16.0
7.7
1.9
2.1
3.7
5.4
2.5
0.0
0.1
0.1
0.1
0.0
0.0
0.0
Table 11 shows the rates of detection for infection, reactive changes, and the total benign cellular changes
for both the ThinPrep
®
and conventional methods at all sites.
Table 11: Benign Cellular Changes Results
ThinPrep
Conventional
N % N %
Benign
Cellular
Infection
1392 20.6 1348 20.0
Changes Reactive
Changes
412 6.1 471 7.0
Total*
1592 23.6 1591
23.6
* Total includes some patients that may have had both an infection and reactive cellular change.
Note: Some patients had more than one diagnostic subcategory.