Hologic thinprep 2000 - Summary of Specimen Adequacy Results; Specimen Adequacy Results

MAN-02624-001 Rev. 003 page 11 of 15
Tables 12, 13, and 14 show the specimen adequacy results for the ThinPrep method and conventional
smear method for all of the study sites. Of the 7,360 total patients enrolled, 7,223 are included in this
analysis. Cases with patient’s age less than 18 years or patients with a hysterectomy were excluded
from this analysis.
Two additional clinical studies were conducted to evaluate specimen adequacy results when samples
were deposited directly into the PreservCyt
®
vial, without first making a conventional Pap smear. This
specimen collection technique is the intended use for the ThinPrep 2000 System. Tables 15 and 16
present the split sample and direct to vial results.
Table 12: Summary of Specimen Adequacy Results
Specimen Adequacy ThinPrep Conventional
Number of Patients: 7223
N % N %
Satisfactory 5656 78.3 5101 70.6
Satisfactory for Evaluation but
Limited by:
Air-Drying Artifact
Thick Smear
Endocervical Component Absent
Scant Squamous Epithelial
Component
Obscuring Blood
Obscuring Inflammation
No Clinical History
Cytolysis
Other
1431
1
9
1140
150
55
141
12
19
10
19.8
0.0
0.1
15.8
2.1
0.8
2.0
0.2
0.3
0.1
2008
136
65
681
47
339
1008
6
119
26
27.8
1.9
0.9
9.4
0.7
4.7
14.0
0.1
1.6
0.4
Unsatisfactory for Evaluation:
Air-Drying Artifact
Thick Smear
Endocervical Component Absent
Scant Squamous Epithelial
Component
Obscuring Blood
Obscuring Inflammation
No Clinical History
Cytolysis
Other
136
0
0
25
106
23
5
0
0
31
1.9
0.0
0.0
0.3
1.5
0.3
0.1
0.0
0.0
0.4
114
13
7
11
47
58
41
0
4
9
1.6
0.2
0.1
0.2
0.7
0.8
0.6
0.0
0.1
0.1
Note: Some patients had more than one subcategory.
Table 13: Specimen Adequacy Results
Conventional
SAT SBLB UNSAT TOTAL
ThinPrep SAT
4316 1302 38 5656
SBLB
722
665 44 1431
UNSAT
63 41
32 136
TOTAL
5101 2008 114
7223
SAT=Satisfactory, SBLB=Satisfactory But Limited By, UNSAT=Unsatisfactory