Hologic ThinPrep 5000 - Page 35

ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 29/36
among all specimens of ASC-US+ diagnosis with ThinPrep 2000 slides by a majority of laboratory
CT/Pathologists. NPA is the negative percent agreement, percent of specimens of <ASC-US
diagnosis with ThinPrep 5000 slides by a majority of laboratory CT/Pathologists among all
specimens of <ASC-US diagnosis with ThinPrep 2000 slides by a majority of laboratory
CT/Pathologists.
Precision Studies
Within- and between-instrument precision of the ThinPrep 5000 processor were evaluated in
laboratory studies using a split-sample technique.
Within-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 the same instrument. A total of 80
specimens were enrolled in the study. Each specimen was split into three portions and
processed on three separate runs of one instrument. The slides were stained, coverslipped, and
then reviewed by cytotechnologists. The resulting diagnoses and specimen adequacy
determinates are presented below. Seventy eight (78) specimens had all three satisfactory
ThinPrep 5000 slides and 2 specimens had all slides with UNSAT results. For comparison, the
same procedure was carried out using a ThinPrep 2000 system, with results also presented
below.
Table 28: Within-Instrument Precision
ThinPrep 5000 ThinPrep 2000*
Percent of specimens that have three matching NILM
replicates or three matching ASC-US+ replicates
97.4%
(76/78)
(91.1% to 99.3%)
97.2%
(69/71)
(90.3% to 99.2%)
Percent of specimens that have three matching <LSIL
replicates or three matching LSIL+ replicates
98.7%
(77/78)
(93.1% to 99.8%)
97.2%
(69/71)
(90.3% to 99.2%)
Percent of specimens that have three matching <HSIL
replicates or three matching HSIL+ replicates
98.7%
(77/78)
(93.1% to 99.8%)
100%
(71/71)
(94.9% to 100%)
Percent of specimens that have three matching
Satisfactory replicates or three matching UNSAT
replicates
100%
(80/80)
(95.4% to 100%)
100%
(71/71)
(94.9% to 100%)
* 80 specimens were enrolled, but 9 were excluded due to slide breakage and other errors.