Hologic ThinPrep Operator's Manual page 12

G.2.1 Laboratory and Patient Characteristics
The cytology laboratories participating in the study were comprised of three (3) centers. All
sites selected had extensive experience in the processing and evaluation of gynecologic
ThinPrep slides, and were trained in the use of the ThinPrep Integrated Imager.
Number of patients (planned and analyzed)
2520 slides (840 each site) were enrolled in this study. Six (6) out of 2520 (0.2%) slides were
excluded from review and analysis as they were broken and unreadable.
Basic demographic information was collected for each slide enrolled at each site to aid the
cytotechnologist in making a diagnosis for the resulting slides. A summary of this demographic
information is presented in Table 4 for all sites.
Site
Number
1
2
3
Overall
Each slide was reviewed independently three (3) times at each site, by three (3) separate pairs of
cytotechnologists and pathologists using normal laboratory and clinical procedures. This
produced a total of 7542 diagnostic results. None of these results were excluded from analysis.
Main Eligibility Criteria
Inclusion Criteria
Study slides (two slides per case, one slide was prepared on the ThinPrep 2000 System and
another slide was prepared on the ThinPrep 5000 processor) were produced, reviewed manually
and adjudicated during the execution of a previous study
three sites included the following:
o NILM:
o ASC-US:
o LSIL:
o ASC-H:
o AGUS:
o HSIL:
o Cancers:
Exclusion Criteria
Slide broken or rendered unreadable for the purposes of this study.
Criteria for Evaluation
The primary objective of this study was to estimate the sensitivity, specificity, and likelihood
ratios when diagnosing slides imaged and reviewed on the Integrated Imager (sequential
Table 4. Site Demographics
Age (yrs) # Hysterectomy
Median (% of enrolled)
36 yrs 11 (2.6%)
33 yrs 15 (3.6%)
37 yrs 25 (6.0%)
35 yrs 51 (4.0%)
1260 slides from 630 cases
300 slides from 150 cases
300 slides from 150 cases
300 slides from 150 cases
30 slides from 15 cases
300 slides from 150 cases
30 slides from 15 cases
# Postmenopausal
(% of enrolled)
30 (7.1%)
25 (6.0%)
51 (12.1%)
106 (8.4%)
2
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