Hologic ThinPrep 5000 Instruction Manual page 6

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%.
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.
Laboratory Characteristics
Type of Patient
Site
Population
S1 Screening
S2 Screening
S3 Screening
H1 Hospital
H2 Hospital
H3 Hospital
Clinical Study Results
The diagnostic categories of The Bethesda System were used as the basis of the comparison
between conventional and ThinPrep
classification data and statistical analyses for all clinical sites are presented in Tables 2
through 11. Cases with incorrect paperwork, patient's age less than 18 years, cytologically
unsatisfactory slides, or patients with a hysterectomy were excluded from this analysis. Few
cases of cervical cancer (0.02%
United States patient population.
Table 1: Site Characteristics
Laboratory
Volume - Smears Cases
per Year
300,000 1,386
100,000 1,668
96,000 1,093
35,000 1,046
40,000 1,049
37,000 981
®
findings from the clinical study. The diagnostic
3
) were represented in the clinical study, as is typical in the
2
The hospital centers in the study serve a
Clinical Study Demographics
Patient Post-
Age Range Menopausal
18.0–84.0 10.6%
18.0–60.6 0.3%
18.0–48.8 0.0%
18.1–89.1 8.1%
18.1–84.4 2.1%
18.2–78.8 11.1%
MAN-04008-001 Rev. 001
Previous Convent.
Abnormal Prevalence
Pap Smear LSIL+
8.8% 2.3%
10.7% 2.9%
7.1% 3.8%
40.4% 9.9%
18.2% 12.9%
38.2% 24.2%
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