Hologic ThinPrep 5000 Instruction Manual page 2

INTENDED USE
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The ThinPrep 5000 processor is intended as a replacement for the conventional method of Pap smear
preparation for use in 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/Vaginal
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Cytologic Diagnoses .
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
capped, labeled, and sent to a laboratory equipped with a ThinPrep 5000 processor.
At the laboratory, the PreservCyt sample vial is barcoded 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 processor 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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Solution (PreservCyt). The ThinPrep sample vial is then
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