Hologic thinprep 2000 - Clinical Study Results; Site Characteristics; Diagnostic Classification Table, All Categories

MAN-02624-001 Rev. 003 page 6 of 15
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%
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.
Table 2: Diagnostic Classification Table, All Categories
Conventional
NEG ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL
ThinPrep NEG
5224 295 3 60 11 0 0 5593
ASCUS
318
125 2 45 7 0 0 497
AGUS 13 2 3 0 1 0 1 20
LSIL 114 84 0 227 44 0 0 469
HSIL 11 15 0 35 104 2 0 167
SQ CA 0 0 0 0 0 1 0 1
GL CA 0 0 0 0 0 0 0 0
TOTAL 5680 521 8 367 167 3 1 6747
Abbreviations for Diagnoses: NEG = Normal or negative, ASCUS = Atypical Squamous Cells of
Undetermined Significance, AGUS = Atypical Glandular Cells of Undetermined Significance, LSIL = Low-
grade Squamous Intraepithelial Lesion, HSIL = High-grade Squamous Intraepithelial Lesion, SQ CA =
Squamous Cell Carcinoma, GL CA = Glandular Cell Adenocarcinoma