ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 2/36
INTENDED USE
The ThinPrep 5000 Processor is part of the ThinPrep System. It is used to prepare ThinPrep
microscope slides from ThinPrep PreservCyt vials for use as a replacement for the conventional
method of Pap smear preparations for screening for the presence of atypical cells, cervical
cancer, or its precursor lesions (Low-grade Squamous Intraepithelial Lesions, High-grade
Squamous Intraepithelial Lesions) as well as all other cytologic categories as defined by The
Bethesda System for Reporting Cervical Cytology. Also for preparation of ThinPrep slides from
non-gynecologic (non-gyn) samples, including urine samples. For professional use.
SUMMARY AND EXPLANATION OF THE SYSTEM
The ThinPrep process begins with the patient’s gynecologic sample being collected by the
clinician using a cervical sampling device which, rather than being smeared on a microscope
slide, is immersed and rinsed in a vial filled with 20 ml of PreservCyt™ Solution (PreservCyt). The
ThinPrep sample vial is then capped, labeled, and sent to a laboratory equipped with a ThinPrep
5000 Processor.
At the laboratory, the PreservCyt sample vial is bar-coded along with the test request form to
establish a sample chain of custody and is placed into a ThinPrep 5000 Processor. A glass slide
bearing the same sample identification number as on the sample vial is loaded into the
Processor. A gentle dispersion step mixes the cell sample by currents in the fluid that are strong
enough to separate debris and disperse mucus, but gentle enough to have no adverse effect on
cell appearance.
The cells are then captured on a Gynecological ThinPrep Pap Test Filter that is specifically
designed to collect cells. The ThinPrep 5000 constantly monitors the rate of flow through the
ThinPrep Pap Test Filter during the collection process in order to prevent the cellular
presentation from being too scant or too dense. A thin layer of cells is then transferred to a glass
slide in a 20 mm-diameter circle, and the slide is automatically deposited into a fixative solution.
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