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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
Labo
ator
Cha
acteristics Clinical Study Demographics
Site
Type of Patient
Population
Labo
atory
Volume - Smear
per Year Cases Patient
Age Range Post-
Menopausal
Pre
ious
Abnormal
Pap Smear
Con
ent.
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%
Clinical Study Results
The diagnostic categories of The Bethesda System were used as the basis of the comparison
between conventional and ThinPrep® findings from the clinical study. The diagnostic
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%3) were represented in the clinical study, as is typical in the
United States patient population.
