INTRODUCTION
ThinPrep 2000 Processor Operator’s Manual
1.1
Chapter One
Introduction
This chapter describes an overview and the principles of operation of the ThinPrep
®
2000 system for
gynecologic sample processing.
Note:
Specific processing steps using the ThinPrep 2000 system must be followed for specimens
undergoing subsequent testing for
Chlamydia trachomatis
and
Neisseria gonorrhoeae
using the
Roche Diagnostics COBAS AMPLICOR™ CT/NG test. (See Chapter 5B, “Operating
Instructions for Processing COBAS AMPLICOR™ CT/NG Samples”.)
OVERVIEW AND FUNCTION OF THE THINPREP
®
2000 SYSTEM
The ThinPrep 2000 system is used in the processing of fluid-based gynecologic specimens for use
with the ThinPrep
®
Pap test. The samples are collected, processed, transferred and fixed onto
microscope slides in preparation for staining, coverslipping and screening. The processor produces
thin, uniform preparations of cells on ThinPrep microscope slides.
Indication for Use
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
.
1. Kurman RJ, Solomon D. The Bethesda System for Reporting Cervical/Vaginal Cytologic Dis-
eases, Springer-Verlag, New York 1994.
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