ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 4/36
specimens and to the Roche Diagnostics COBAS AMPLICOR CT/NG package insert for
instructions for use of that system.
If any serious incident occurs related to this device, or any components used with this device,
report it to Hologic Technical Support and the competent authority local to the user and/or
patient.
LIMITATIONS
• Gynecologic samples collected for preparation using the ThinPrep 5000 System should
be collected using a broom-type or endocervical brush/plastic spatula combination
collection devices. Refer to the instructions provided with the collection device for
warnings, contraindications, and limitations associated with specimen collection.
• Preparation of microscope slides using the ThinPrep 5000 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 5000 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 by the ThinPrep 5000 System are those designed and supplied by Hologic
specifically for the ThinPrep 5000 System. These include PreservCyt Solution vials,
ThinPrep Pap Test Filters, and ThinPrep Microscope Slides. Alternative collection media,
filters, and slides have not been validated by Hologic and may lead to erroneous results.
Hologic does not provide a warranty for results using any of these alternatives. Product
performance may be compromised if supplies that have not been validated by Hologic
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 sample vials reprocessed with
glacial acetic acid (GAA) has not been evaluated.
CONTRAINDICATIONS
• Chlamydia trachomatis and Neisseria gonorrhoeae testing using the Hologic APTIMA
COMBO 2™ CT/NG and the Roche Diagnostics COBAS AMPLICOR assays should not be
performed on a sample that has already been processed using the ThinPrep 5000
processor.
To Next Page
Loading...
