Hologic thinprep 2000 - Page 4

MAN-02060-001 Rev. 005 page 4 of 14
PRECAUTIONS
 Specific processing steps must be followed before and during use of the ThinPrep 2000 processor if
planning to perform Chlamydia trachomatis and Neisseria gonorrhoeae testing, using the Roche
Diagnostics COBAS AMPLICOR CT/NG test, on the residual specimen after a slide has been
prepared using a ThinPrep 2000 processor. Follow the procedures found in Chapter 5B of the
ThinPrep 2000 Operator’s Manual.
 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 number of viable organisms
found after 15 minutes in the PreservCyt Solution. The log reduction of viable organisms is also
presented. As with all laboratory procedures, universal precautions should be followed.
Organism Initial Concentration
Log Reduction after
15 min.
Candida albicans 5.5 x 10
5
CFU/mL >4.7
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***
HIV-1 1.0 x 10
7.5
TCID
50
/mL 7.0***
* After 1 hour >4.7 log reduction
** After 1 hour >5.7 log reduction
*** Data is for 5 minutes