Hologic ThinPrep 5000 - Page 36

ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 30/36
Between-Instrument Precision
The study was designed to examine the ability of the ThinPrep 5000 system to prepare
reproducible slides from the same patient specimen using multiple instruments. A total of 120
specimens were enrolled in the study. Each specimen was split into three portions and
processed on three instruments. The slides were stained, coverslipped, and then reviewed by
cytotechnologists. The resulting diagnoses and specimen adequacy determinates are presented
below. One hundred seventeen (117) specimens had all three satisfactory ThinPrep 5000 slides,
one specimen had two slides with UNSAT result and one slide with Satisfactory result, one
specimen had two slides with Satisfactory result and one slide with UNSAT result, and one
specimen was excluded from analysis due to a broken slide. For comparison, the same
procedure was carried out using a ThinPrep 2000 system, with results also presented below.
Table 29: Between-Instrument Precision
ThinPrep 5000 ThinPrep 2000*
Percent of specimens that have three matching NILM
replicates or three matching ASC-US+ replicates
94.0%
(110/117)
(88.2% to 97.1%)
91.1%
(102/112)
(84.3% to 95.1%)
Percent of specimens that have three matching <LSIL
replicates or three matching LSIL+ replicates
97.4%
(114/117)
(92.7% to 99.1%)
94.6%
(106/112)
(88.8% to 97.5%)
Percent of specimens that have three matching <HSIL
replicates or three matching HSIL+ replicates
98.3%
(115/117)
(94.0% to 99.5%)
100%
(112/112)
(96.7% to 100%)
Percent of specimens that have three matching
Satisfactory replicates or three matching UNSAT
replicates
98.3%
(117/119)
(94.1% to 99.5%)
98.3%
(113/115)
(93.9% to 99.5%)
* 120 specimens were enrolled, but 5 were excluded due to slide breakage and other errors.
Cell Count Study
The quantity of cellular material transferred onto slides, comparing ThinPrep 5000 to the
ThinPrep 2000, was evaluated in a laboratory study using a split-sample technique.
Two hundred ten (210) specimens were enrolled in the study (139 NILM, 28 ASC-US, 28 LSIL, and
15 HSIL). Each specimen was split into two parts, processed on a ThinPrep 2000 and ThinPrep