Hologic thinprep 2000 - Page 6

MAN-02060-001 Rev. 005 page 6 of 14
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
Table 3: Three Category Diagnostic Classification Table
Conventional
NEG ASCUS/AGUS+ LSIL+ TOTAL
ThinPrep NEG 5224 298 71 5593
ASCUS/
AGUS+
331 132 54 1154
LSIL+ 125 99 413 637
TOTAL 5680 529 538 6747
Table 4: Two Category Diagnostic Classification Table, LSIL and More Severe Diagnoses
Conventional
NEG/ASCUS/
AGUS+
LSIL+ TOTAL
ThinPrep NEG/ASCUS/
AGUS+
5985 125 6110
LSIL+ 224 413 637
TOTAL 6209 538 6747