Hologic ThinPrep 5000 Instruction Manual page 25

Deming regression analysis was performed and the slope was 0.98 with 95% CI: 0.94 to 1.01 and the
intercept was 300 with 95% CI: -300 to 897. The data demonstrate similar cell count values on the
ThinPrep 2000 and ThinPrep 5000 slides.
Cellular Carry-Over Study
Cellular carry-over between slides was evaluated in a laboratory study, with comparison of the
ThinPrep 5000 and ThinPrep 2000.
On each system, 200 abnormal clinical specimens were processed, alternating with 200 blank
PreservCyt vials containing no cells. After processing, slides made from the blank vials were
segregated from cellular slides, stained and coverslipped, then reviewed by cytotechnologists. Any
cells found on a slide were noted. Slides made from a blank vial but containing at least one cell were
considered to have cellular carry-over.
The carry-over study results are presented in Table 30 below.
Table 30: Cellular Carry-Over
Total # of Slides
# Slides with carry -over
% Slides with carry-over
Number of cells on the slides with
carry-over: Median (Min, Max)
CONCLUSIONS
®
The ThinPrep 2000 system is as effective as the conventional Pap smear in a variety of patient
populations and may be used as a replacement for the conventional Pap smear method for the detection of
atypical cells, cervical cancer, or its precursor lesions, as well as all other cytologic categories as defined
by The Bethesda System.
The ThinPrep 2000 system is significantly more effective than the conventional Pap smear for the
detection of Low-grade Squamous Intraepithelial (LSIL) and more severe lesions in a variety of patient
populations.
Specimen quality with the ThinPrep 2000 system is significantly improved over that of conventional Pap
smear preparation in a variety of patient populations.
Considering the technological similarity to the ThinPrep 2000 system and the comparative clinical and
analytical study results, it is concluded that the ThinPrep 5000 processor is similar to the ThinPrep 2000
processor and may be used as a replacement for the conventional Pap smear method for the detection of
atypical cells, cervical cancer, or its precursor lesions, as well as all other cytologic categories as defined
by The Bethesda System.
ThinPrep 5000
200
4
2.0%
1
(1,5)
ThinPrep 2000
200
38
19.0%
2
(1,28)
MAN-04008-001 Rev. 001 Page 25 of 27