Hologic thinprep 2000 - Intended Use; Summary and Explanation of the System; The Thinprep Sample Preparation Process

MAN-02624-001 Rev. 003 page 2 of 15
INTENDED USE
The ThinPrep
®
2000 System 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 Cytologic Diagnoses
1
.
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 2000 Processor.
At the laboratory, the PreservCyt sample vial is placed into a ThinPrep 2000 Processor and a
gentle dispersion step breaks up blood, mucus, non-diagnostic debris, and thoroughly mixes the
cell sample. The cells are then collected on a ThinPrep Pap Test Filter specifically designed to
collect diagnostic cells. The ThinPrep 2000 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.
The ThinPrep Sample Preparation Process
(1) Dispersion (2) Cell Collection (3) Cell Transfer
The ThinPrep Pap Test Filter rotates within the
sample vial, creating 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.
A gentle vacuum is created within the ThinPrep
Pap Test Filter, which collects cells on the
exterior surface of the membrane. Cell
collection is controlled by the ThinPrep 2000
Processor’s software that monitors the rate of
flow through the ThinPrep Pap Test Filter.
After the cells are collected on the membrane,
the ThinPrep Pap Test Filter is inverted and
gently pressed against the ThinPrep Microscope
Slide. Natural attraction and slight positive air
pressure cause the cells to adhere to the
ThinPrep Microscope Slide resulting in an even
distribution of cells in a defined circular area.