Hologic ThinPrep 5000 - Page 11

ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 5/36
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.
• Alternative collection media, filters and slides have not been validated by Hologic and
may lead to erroneous results.
PRECAUTIONS
• This equipment generates, uses and can radiate radio frequency energy, and if not
installed and used in accordance with the Operator’s Manual, may cause interference to
radio communications. Operation of this equipment in a residential area is likely to cause
harmful interference, in which case the user will be required to correct the interference at
his/her own expense.
• PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing must be
stored between 15
o
C (59
o
F) and 30
o
C (86
o
F) and tested within 6 weeks of collection.
• PreservCyt Solution with cytologic sample intended for CT/NG testing using the Roche
Diagnostics COBAS AMPLICOR CT/NG test must be stored between 4
o
C (39
o
F) and 25
o
C
(77
o
F) and tested within 6 weeks of collection.
• PreservCyt Solution was challenged with a variety of microbial and viral organisms. The
following table presents the starting concentrations of viable organisms, and the log
reduction of viable organisms found after 15 minutes in the PreservCyt Solution. As with
all laboratory procedures, universal precautions should be followed.
Organism Initial Concentration
Log Reduction After
15 Minutes
Candida albicans 5.5 x 10
5
CFU/ml ≥4.7
Candida auris 2.6 x 10
5
CFU/ml ≥5.4
Aspergillus niger 4.8 x 10
5
CFU/ml 2.7*
Escherichia coli 2.8 x 10
5
CFU/ml ≥4.4
Staphylococcus aureus 2.3 x 10
5
CFU/ml ≥4.4
Pseudomonas aeruginosa 2.5 x 10
5
CFU/ml ≥4.4
Mycobacterium tuberculosis
†
9.4 x 10
5
CFU/ml 4.9**
Rabbitpox virus 6.0 x 10
6
PFU/ml 5.5***