BD FocalPoint GS, User Manual, Page: 95 / 242

The BD FocalPoint™ Slide Profiler
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10.3.1 Successfully Processed Slides
All slides successfully processed by the system (qualified slides) receive an evaluation score that
reflects the presence and composition of cellular elements present in human cervical/vaginal
smears, as well as the associated characteristics of the specimen. This evaluation score is used
to calculate slide processing results that reflect the likelihood that a slide contains abnormalities,
or unsatisfactory conditions. Cellular elements that may be evaluated include: squamous
epithelial cells, endocervical cells, squamous intraepithelial lesions (SIL), adenocarcinoma cells,
squamous carcinoma cells, and various other atypical cell conditions as defined by The
Bethesda System.
All qualified Pap test slides receive an action of
No Further Review or Review. Additionally,
designated slides receive an action of QC Review . Each of these actions is described in the
following paragraphs.
No Further Review Slides
The No Further Review slides have the highest likelihood of being normal and can be archived
by the laboratory as being NILM. No Further Review slides must meet the following criteria:
• The slide and the specimen must be adequately prepared for automated scanning and pass
a set of suitability tests.
• The slide must receive algorithm scores within preset ranges.
• System integrity determines if the optical, mechanical, and electronic systems are operating
within normal ranges during slide processing.
For additional details on processing conventional Pap smear slides, refer to Section 18.
Review Slides
These slides are ranked according to their likelihood of containing an abnormality. The ranked
slides in each print set are further grouped into Quintiles.
QC Review (Rescreen) Slides
During normal operation, up to 15% of the highest ranking slides interpreted as NILM by the
cytotechnologist and classified as
Review
by the BD FocalPoint™ Slide Profiler are selected for
directed QC rescreening.
Refer to Section 19 for a detailed description of recommended QC procedures.
NOTE
Contact your Customer Representative for regional limitations for
use of No Further Review.
Intended use
Primary Screener
Guided Screener
Slide Type
U.S. AND
CANADA
OUTSIDE U.S.
AND CANADA
U.S. AND
CANADA
OUTSIDE U.S.
AND CANADA
Conventional Slides Yes Yes No Yes
BD SurePath™
Slides
Yes Yes Yes Yes