Hologic thinprep 2000 - Page 3

MAN-02060-001 Rev. 005 page 3 of 14
The PreservCyt
®
Solution component of the ThinPrep 2000 System is an alternative collection
and transport medium for gynecologic specimens tested with the Digene Hybrid Capture System
HPV DNA and Hologic APTIMA COMBO 2
®
CT/NG Assays. Refer to the respective
manufacturer’s package inserts for instructions for using PreservCyt Solution for collection,
transport, storage, and preparation of specimens for use in those systems.
The PreservCyt Solution component of the ThinPrep 2000 System is also an alternative collection
and transport medium for gynecologic specimens tested with the Roche Diagnostics COBAS
AMPLICOR
TM
CT/NG assay. Refer to Hologic’s labeling (Document #MAN-02063-001) for
instructions for using PreservCyt Solution for collection, transport, storage, and preparation of
specimens and to the Roche Diagnostics COBAS AMPLICOR CT/NG package insert for
instructions for use of that system.
LIMITATIONS
 Gynecologic samples collected for preparation using the ThinPrep 2000 System should be
collected using a broom-type or endocervical brush/plastic spatula combination collection
devices.
 Preparation of microscope slides using the ThinPrep 2000 System should be performed only
by personnel who have been trained by Hologic or by organizations or individuals designated
by Hologic.
 Evaluation of microscope slides produced with the ThinPrep 2000 System should be
performed only by cytotechnologists and pathologists who have been trained to evaluate
ThinPrep prepared slides by Hologic or by organizations or individuals designated by
Hologic.
 Supplies used in the ThinPrep 2000 System are those designed and supplied by Hologic
specifically for the ThinPrep 2000 System. These include PreservCyt Solution vials,
ThinPrep Pap Test Filters, and ThinPrep Microscope Slides. These supplies are required for
proper performance of the system and cannot be substituted. Product performance will be
compromised if other supplies are used. After use, supplies should be disposed of in
accordance with local, state, and federal regulations.
 A ThinPrep Pap Test Filter must be used only once and cannot be reused.
 The performance of HPV DNA and CT/NG testing on reprocessed sample vials has not been
evaluated.
WARNINGS
 For In Vitro Diagnostic Use
 Danger. PreservCyt Solution contains methanol. Toxic if swallowed. Toxic if inhaled. Causes
damage to organs. Flammable liquid and vapor. Keep away from heat, sparks, open flames
and hot surfaces. Other solutions cannot be substituted for PreservCyt Solution. PreservCyt
Solution should be stored and disposed of in accordance with all applicable regulations.
 Do not process a cerebral spinal fluid (CSF) specimen or other sample type that is suspected
of possessing prion infectivity (PrPsc) derived from a person with a TSE, such as Creutzfeldt-
Jakob disease, on the ThinPrep 2000 processor. A TSE contaminated processor cannot be
effectively decontaminated and therefore must be properly disposed of in order to avoid
potential harm to users of the processor or service personnel.