MAN-02060-001 Rev. 005 page 5 of 14
PERFORMANCE CHARACTERISTICS: REPORT OF CLINICAL
STUDIES
A prospective multi-center clinical study was conducted to evaluate the performance of the ThinPrep
2000 System in direct comparison to the conventional Pap smear. The objective of the ThinPrep clinical
study was to demonstrate that gynecologic specimens prepared using the ThinPrep 2000 System were at
least as effective as conventional Pap smears for the detection of atypical cells and cervical cancer or its
precursor lesions in a variety of patient populations. In addition, an assessment of specimen adequacy
was performed.
The initial clinical study protocol was a blinded, split sample, matched pair study, for which a
conventional Pap smear was prepared first, and the remainder of the sample (the portion that normally
would have been discarded) was immersed and rinsed into a vial of PreservCyt Solution. At the
laboratory, the PreservCyt sample vial was placed into a ThinPrep 2000 Processor and a slide was then
prepared from the patient’s sample. ThinPrep and conventional Pap smear slides were examined and
diagnosed independently. Reporting forms containing patient history as well as a checklist of all possible
categories of The Bethesda System were used to record the results of the screening. A single independent
pathologist reviewed all discrepant and positive slides from all sites in a blinded fashion to provide a
further objective review of the results.
LABORATORY AND PATIENT CHARACTERISTICS
Cytology laboratories at three screening centers (designated as S1, S2, and S3) and three hospital centers
(designated as H1, H2, and H3) participated in the clinical study. The screening centers in the study
serve patient populations (screening populations) with rates of abnormality (Low-grade Squamous
Intraepithelial Lesion [LSIL] and more severe lesions) similar to the United States average of less than
5%.
2
The hospital centers in the study serve a high risk referral patient population (hospital populations)
characterized by high rates (>10%) of cervical abnormality. Data on race demographics was obtained
for 70% of the patients that participated in the study. The study population consisted of the following
race groups: Caucasian (41.2%), Asian (2.3%), Hispanic (9.7%), African American (15.2%), Native
American (1.0%) and other groups (0.6%).
Table 1 describes the laboratories and the patient populations.
Table 1: Site Characteristics
Laboratory Characteristics
Clinical Study Demographics
Site
Type of
Patient
Population
Laboratory
Volume -
Smears per
Year
Cases
Patient
Age Range
Post-Meno-
pausal
Previous
Abnormal Pap
Smear
Convent.
Prevalence
LSIL+
S1
Screening
300,000
1,386
18.0 - 84.0
10.6%
8.8%
2.3%
S2
Screening
100,000
1,668
18.0 - 60.6
0.3%
10.7%
2.9%
S3
Screening
96,000
1,093
18.0 - 48.8
0.0%
7.1%
3.8%
H1
Hospital
35,000
1,046
18.1 - 89.1
8.1%
40.4%
9.9%
H2
Hospital
40,000
1,049
18.1 - 84.4
2.1%
18.2%
12.9%
H3
Hospital
37,000
981
18.2 - 78.8
11.1%
38.2%
24.2%
