Hologic ThinPrep Operator's Manual page 21

Site 1
CT 1
CT 2
CT 3
Site 2
CT 1
CT 2
CT 3
Site 3
CT 1
CT 2
CT 3
Combined Median
In this study, the number of equivalent slides reviewed could not be determined as the
review type was not tracked.
CTs using the Integrated Imager scanned and reviewed 67% of the slides that CTs reviewed
when using TIS.
Note: The time recorded for the TIS-reviewed slides does not account for the scanning time.
The scanning time adds approximately 90 seconds per slide when using the Integrated
Imager Sequential Modality.
G2.5 Cytotechnologist Timing Study (Batched and Sequential Modalities)
An additional study "Cytotechnologist Screening Time Study ThinPrep
performed to characterize the screening volumes for cytotechnologists (CTs) when assistive
imaging is implemented as part of the slide review process. These data were collected using the
Integrated Imager in two ways:
1. Each slide was imaged and then reviewed by a CT using the Integrated Imager. This is
referred to as Sequential Modality in this study (i.e., imaging and slide review is performed
consecutively, by the CT).
2. All slides were imaged as a batch using the Integrated Imager and then the CT reviewed
slides as a batch. This is referred to as Batched Modality in this study. In batched modality,
imaging of slides is performed in advance, separate from the slide review.
Three (3) CTs participated in this study. The CTs reviewed slides over three (3) days (screening
slides for an 8-hour day) for each arm of the study. Slides were imaged and reviewed
independently by each of the three CTs.
All slides were prepared from ThinPrep
ThinPrep processor, and stained with ThinPrep Stain. Sets of 400 randomized slides per CT,
each with approximately 10% abnormal diagnosis were provided in order to fully occupy a CT
for three (3) full days of screening. The CTs were blinded to the diagnoses.
A minimum one-week "
Table 19 shows the total breakdown of the types of reviews performed in the CT Timing Study.
Table 18. CT Screening Rates
TIS
Average Slides/Hour
9.8
10.4
11.1
6.2
9.0
9.1
9.2
9.9
10.1
9.8
100%
®
specimens of known cytology diagnoses, on a
washout
period" occurred between study arms for each CT.
I2
Average Slides/Hour
9.9
9.7
8.1
6.1
6.4
6.5
6.6
6.8
6.5
6.6
67%
®
Integrated Imager" was
MAN-05359-001 -001 Rev. 001 page 17 of 32