BD FocalPoint GS, User Manual, Page: 97 / 242

The BD FocalPoint™ Slide Profiler
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10.4.1 Ranking Information
Some of your Review slides may have been classified by the BD FocalPoint™ as scant
cellularity. These slides do not have associated ranking information. The reason for the scant
cellularity classification is that there are not an adequate number of reference cells on the slide to
successfully qualify and rank the slide.
Reference cells are used to identify the slide as a Pap test and assess cellularity. Slides
classified as Scant Cellularity may not be fully processed and therefore must be classified as
Review to receive a manual screen. These slides are not ranked and are collectively at the end
of the ranked list.
It is important to understand that the ranking information is a guide only. Ranking occurs when
the slide reports are printed, which creates the print set. Each slide’s rank is based on its own
evaluation score relative to the other slide scores in the same print set.
10.4.2 Specimen Adequacy Information
The device evaluates slide adequacy according to The Bethesda System slide adequacy criteria.
It reports three adequacy parameters: squamous component (detected, insufficient),
endocervical component (detected, insufficient), and inflammation/obscuration (expressed as a
percentage of the coverslip area). This information appears on all appropriate reports for slides
that were successfully processed. See Section 12 for details on the various reports.
For BD SurePath™ slides
Adequacy criteria for liquid-based slides do not directly correspond to the morphologic criteria set
forth by The Bethesda System. Because the BD FocalPoint™ Slide Profiler evaluates specimen
adequacy according to The Bethesda System, the BD FocalPoint™ Slide Profiler does not
provide a specimen adequacy evaluation (Unsat, Satisfactory But Limited By [SBLB], Sat) on the
slides results reports when the BD FocalPoint™ Slide Profiler is configured to process
BD SurePath™ slides. The BD FocalPoint™ Slide Profiler reports still provide information on
endocervical component detection, squamous component detection, and the percentage of
inflammation or obscuration.
NOTE
Careful review of slides diagnosed as scant cellularity is important,
because samples that exhibit abundant tumor diathesis and/or few
intact epithelial cells are frequently classified as scant cellularity.
NOTE
The ranking information for Scant Cellularity slides may not be
provided. These slides will be placed after the 5th quintile slides in
the ranked report but will not be classified as 5th quintile slides. Also
note that these unranked slides should not be considered for
supplemental slide selection for QC Review.