Ranking Information; Specimen Adequacy Information - BD FocalPoint GS User Manual

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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.

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.

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

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

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

supplemental slide selection for QC Review.

The BD FocalPoint™ Slide Profiler

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