Successfully Processed Slides - BD FocalPoint GS User Manual

Table of Contents

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.

Contact your Customer Representative for regional limitations for

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.

Slide Type

Conventional Slides

BD SurePath™

Slides

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

use of No Further Review.

Intended use

Primary Screener

U.S. AND

OUTSIDE U.S.

CANADA

AND CANADA

Yes

The BD FocalPoint™ Slide Profiler

Guided Screener