Hologic ThinPrep Operator's Manual page 6

A. INTENDED USE
®
The Hologic ThinPrep
primary cervical cancer screening of ThinPrep
cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High
Grade Squamous Intraepithelial Lesions), and carcinoma as well as all other cytologic criteria as defined
by the Bethesda System: Terminology for Reporting Results of Cervical Cytology
B. SUMMARY AND EXPLANATION OF THE SYSTEM
The ThinPrep Integrated Imager is an automated imaging and review system for use with ThinPrep Pap
Test slides. It combines imaging technology to identify microscopic fields of diagnostic interest with
automated stage movement of a microscope in order to locate these fields. In routine use, the ThinPrep
Integrated Imager selects 22 fields of view for a cytotechnologist (CT) to review. Following review of
these fields, the cytotechnologist will either complete the diagnosis if no abnormalities are identified or
review the entire slide if any abnormalities are identified. The ThinPrep Integrated Imager also allows
the physical marking of locations of interest for the cytopathologist.
C. PRINCIPLES OF OPERATION
The ThinPrep Integrated Imager is a combined system which uses computerized image analysis and
automated microscope location to assist a cytotechnologist or pathologist to identify areas of a slide that
are of most interest. Slides used with this system must first be prepared on the ThinPrep
®
or ThinPrep 5000 processors, and stained with ThinPrep
be used as a conventional microscope when not used for ThinPrep
The ThinPrep Integrated Imager images the entire cell spot of the slide in approximately 90 seconds.
The system acquires and processes image data from the slides to identify diagnostically relevant cells or
cell groups based on an imaging algorithm that considers cellular features and nuclear darkness. During
slide imaging, the alphanumeric slide accession identifier is recorded and the x and y coordinates of
22 fields of interest are stored in the system.
After image processing, the device acts as an automated microscope, presenting the 22 fields containing
the cells of interest to the cytotechnologist for review. The cytotechnologist uses the review control or
touch screen to step through each of the fields of interest (Autolocate). Additionally, the review scope
provides a method for automated marking of objects for further review. If the cytotechnologist identifies
any of these fields as containing abnormal objects, that field may be marked electronically. The
Integrated Imager will guide the cytotechnologist to conduct a review of the entire cell spot for any slide
that has had fields electronically marked (Autoscan).
The cytotechnologist determines specimen adequacy and the presence of infections during the review of
the 22 fields of view presented by the ThinPrep Integrated Imager. Either of two methods can be used to
determine specimen adequacy. The first method is to count cells and determine the average number of
cells in the 22 fields of view presented by the Imager. The second method is to count and determine the
average number of cells in 10 fields of view across the diameter of the cell spot. Either method will
enable the cytotechnologist to determine if the minimum cells, as recommended by Bethesda System
criteria, are present on the slide. At the conclusion of the slide review, electronically marked objects are
manually marked on the slide by the cytotechnologist. Slide information is stored in the computer
database including the x and y coordinates representing the electronically marked locations, and the
status of the slide is designated as "complete".
Integrated Imager is a device that uses computer imaging technology to assist in
®
Pap Test slides for the presence of atypical cells,
®
Stain. The ThinPrep Integrated Imager can
®
imaging.
MAN-05359-001 -001 Rev. 001 page 2 of 32
1
.
®
2000 System