BD FocalPoint™ GS Imaging System Instrument User’s Manual
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10.2 Slide Processing
Each prepared Pap test (BD SurePath™ or conventional Pap smear) slide is affixed with a slide
barcode label and loaded into a BD FocalPoint™ slide tray, which holds up to eight slides. Up to
36 trays can be placed in the input hopper for automatic slide processing.
After slide trays are loaded into the BD FocalPoint™ instrument, they are moved automatically
from the input hopper to the microscope stage. The device checks each slide in the tray for
physical integrity, reads the slide barcode label, scans and analyzes the slide at low power
(4x magnification), and then scans and analyzes prioritized fields at high power
(20x magnification).
Before the first tray and after each succeeding tray, a comprehensive system integrity (SI)
assessment of the instrument is automatically performed to ensure that all data collection and
image analysis mechanisms are operating within specified limits. The results of all these tests
are compared to specific performance limits to validate the processing result for each slide in the
tray.
During processing, all slides are checked for physical integrity, are scanned and evaluated, and
are further qualified by system integrity checks. As slides are successfully processed on the
BD FocalPoint™ instrument, they are said to become qualified.
Results for BD SurePath™ and Conventional qualified slides are validated and receive a slide
processing results action of
Review. These slide results can then be printed in one of several
report formats. Refer to Section 14 for details on these formats.
10.3 Slide Processing Results
The BD FocalPoint™ Slide Profiler algorithms are able to detect evidence of morphologic
changes associated with epithelial abnormalities, and specimen adequacy. If a slide is
successfully processed on the system, it is evaluated and scored with regard to these
morphological changes. However, if a slide cannot be successfully processed on the system
because of physical or specimen limitations, the slide is not scored. Each of these events is
discussed in the following paragraphs.
NOTE
BD FocalPoint™ Slide Profiler characterization of slides as No
Further Review is not intended to replace current laboratory protocol
where a primary health care provider has requested special
handling of a case (slide) for a specified concern, or where the
laboratory through its own procedures has identified a need for
additional screening of the case.
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