ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 7/36
PERFORMANCE CHARACTERISTICS: REPORT OF CLINICAL STUDIES
The ThinPrep 5000 System is technologically similar to the ThinPrep 2000 System. A critical
review of the ThinPrep 5000 System demonstrated that the clinical evaluation of the ThinPrep
2000 System applies to the ThinPrep 5000 System and is described below.
ThinPrep 2000 System Compared to Conventional Pap Smear
A prospective multi-center clinical study was conducted to evaluate the performance of the
ThinPrep 2000 System in direct comparison to the conventional Pap smear. The objective of the
ThinPrep clinical study was to demonstrate that gynecologic specimens prepared using the
ThinPrep 2000 System were at least as effective as conventional Pap smears for the detection of
atypical cells and cervical cancer or its precursor lesions in a variety of patient populations. In
addition, an assessment of specimen adequacy was performed.
The initial clinical study protocol was a blinded, split sample, matched pair study, for which a
conventional Pap smear was prepared first, and the remainder of the sample (the portion that
normally would have been discarded) was immersed and rinsed into a vial of PreservCyt Solution.
At the laboratory, the PreservCyt sample vial was placed into a ThinPrep 2000 Processor and a
slide was then prepared from the patient’s sample. ThinPrep and conventional 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%).
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