Hologic ThinPrep 5000 Instruction Manual page 23

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
Percent of specimens that have three
matching NILM replicates or three
matching ASC-US+ replicates
Percent of specimens that have three
matching <LSIL replicates or three
matching LSIL+ replicates
Percent of specimens that have three
matching <HSIL replicates or three
matching HSIL+ replicates
Percent of specimens that have three
matching Satisfactory replicates or
three matching UNSAT replicates
* 80 specimens were enrolled, but 9 were excluded due to slide breakage and other errors.
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.
ThinPrep 5000
97.4%
(76/78)
(91.1% to 99.3%)
98.7%
(77/78)
(93.1% to 99.8%)
98.7%
(77/78)
(93.1% to 99.8%)
100%
(80/80)
(95.4% to 100%)
ThinPrep 2000*
97.2%
(69/71)
(90.3% to 99.2%)
97.2%
(69/71)
(90.3% to 99.2%)
100%
(71/71)
(94.9% to 100%)
100%
(71/71)
(94.9% to 100%)
MAN-04008-001 Rev. 001 Page 23 of 27