Hologic ThinPrep 5000, Operator'S Manual

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I
NTRODUCTION
1.6
ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual
1
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°C (59°F) and 30°C (86°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°C (39°F) and 25°C
(77°F) and tested within 6 weeks of collection.
• Always use the USB drive provided with the processor. Never use a U3 Smart Drive. While
the system is able to write to this device, there is a significant problem if the system is booted
with one of these drives inserted in a port. Field service would be required.
• Note also that the system cannot write data to a write-protected USB key.
• 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***
HIV-1
3.2 x 10
7
TCID
50
/ml
≥7.0***
Hepatitis B virus
†
2.2 x 10
6
TCID
50
/ml
≥4.25
SARS-CoV-2 virus
1.8 x 10
6
TCID
50
/ml
≥3.75