Hologic ThinPrep 5000 Instruction Manual page 5

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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.
PERFORMANCE CHARACTERISTICS:
REPORT OF CLINICAL STUDIES
The ThinPrep 5000 processor is technologically similar to the ThinPrep 2000 system. The performance
characteristics of the ThinPrep 5000 processor are predicated on those of the ThinPrep 2000 system. Both
the clinical studies for the ThinPrep 2000 system and those comparing the ThinPrep 5000 processor to the
ThinPrep 2000 are described in the following sections.
ThinPrep 2000 System Compared to Conventional Pap Smear
A prospective multi-center clinical study was conducted to evaluate the performance of the
ThinPrep 2000 system in direct comparison to the conventional Pap smear. The objective of the
ThinPrep clinical study was to demonstrate that gynecologic specimens prepared using the
ThinPrep 2000 system were at least as effective as conventional Pap smears for the detection of
atypical cells and cervical cancer or its precursor lesions in a variety of patient populations. In
addition, an assessment of specimen adequacy was performed.
The initial clinical study protocol was a blinded, split sample, matched pair study, for which a
conventional Pap smear was prepared first, and the remainder of the sample (the portion that
normally would have been discarded) was immersed and rinsed into a vial of PreservCyt
Solution. At the laboratory, the PreservCyt sample vial was placed into a ThinPrep 2000
processor and a slide was then prepared from the patient's sample. ThinPrep and conventional
Organism
Candida albicans
Aspergillus niger*
Escherichia coli
Staphylococcus aureus
Pseudomonas
aeruginosa
Mycobacterium
tuberculosis**
Rabbitpox virus
HIV-1
* After 1 hour >4.7 log reduction
** After 1 hour >5.7 log reduction
*** Data is for 5 minutes
Initial Concentration
5
5.5 x 10 CFU/mL
5
4.8 x 10 CFU/mL
5
2.8 x 10 CFU/mL
5
2.3 x 10 CFU/mL
5
2.5 x 10 CFU/mL
5
9.4 x 10 CFU/mL
6
6.0 x 10 PFU/mL
7.5
1.0 x 10 TCID /mL
50
Log Reduction
After 15 Minutes
>4.7
>2.7
>4.4
>4.4
>4.4
>4.9
>5.5***
>7.0***
MAN-04008-001 Rev. 001 Page 5 of 27