Hologic ThinPrep, Руководство оператора

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MAN-08723-001 Rev. 001 page 12 of 28
All ThinPrep ® slides that produced discordant unsatisfactory determinations ( Manual Review arm
vs. Imager Review arm) during the clinical study were assessed in an additional clinical support
study to compare the method used for specimen adequacy in the clinical study with a control cell
count of the slides and 3 different methods as follows: (1) Manual assessment of specimen adequacy
on the entire microscope slide based on ThinPrep Bethesda System 1991 criteria; (2) Using the
“diameter” method of Bethesda System 2001, which requires that the Cytotechnologist counts cells
in 10 fields of view along the diameter of the cell spot and calculate the number of cells on the slide;
(3) Having the Cytotechnologist count the cells in the 22 fields of view presented by the system and
calculate the number of cells on the slide.
This additional support study demonstrated that the Bethesda System 1991 estimation methods,
including the method used in the clinical study, do not generate similar specimen adequacy
determinations when compared against each other or with the control method. Therefore, the
recommended methods for determining specimen adequacy on the ThinPrep Imaging System are
(1) the Bethesda System 2001 count of fields along a diagonal of the cell spot or (2) counting the
cells in the 22 fields-of-view selected by the ThinPrep Imager System. Refer to the ThinPrep
Imaging System Review Scope Operator’s Manual for instructions on the proper use of these
methods.
G.5 CYTOTECHNOLOGIST SCREENING RATES
Daily Cytotechnologist screening rates were recorded throughout the duration of the clinical study.
The study was conducted in a manner designed to reproduce actual clinical conditions. Eight (8)
Cytotechnologists participated in the study; two (2) at each clinical site. The experience levels of
the Cytotechnologists ranged from 5 to 23 years. During the study the Cytotechnologist’s screening
times for the
Imager Review arm included automated screening of the 22 fields of view with
subsequent full side review of abnormal slides. A full slide review consists of approximately 120
fields of view. The number of hours each Cytotechnologist screened slides per day varied due to
logistical issues and scheduling. With the ThinPrep Imaging System, Cytotechnologist screening
rates were uniformly faster than the
Manual Review method.
Table 14 summarizes the Cytotechnologist screening rates for both the Imager Review and the
Manual Review methods. The total number of slides reviewed in the study and the average number
of hours screened per day are presented for each Cytotechnologist and site. Screening rates
(extrapolated to an 8 hour workday) are presented as the low, average and high daily screening rates
achieved by each Cytotechnologist and site. The low and high daily rates were selected from the
lowest and highest daily hourly rates, respectively, and are extrapolated to 8 hours.