Staining Not Within Limits; Image Quality Not Within Limits - BD FocalPoint GS User Manual

BD FocalPoint™ GS Imaging System Instrument User's Manual
21.3

Staining Not Within Limits

The BD FocalPoint™ Slide Profiler evaluates each slide to verify that it is suitably stained. Stain
characteristics of the slide are analyzed with respect to their influence on the scanning
performance of the instrument. A slide determined by the system to be unsuitable for analysis is
reported as Staining not within limits with the description of the failure given. If the laboratory
identifies a subset of slides that cannot be rerun through the device, these slides must be
screened by a cytotechnologist.
The following list describes the reasons for which a slide may be rejected:
Cytoplasm staining
The cytoplasm stain density is not within limits. These slides must be screened by a
cytotechnologist.
Nuclear/cytoplasmic contrast
The N/C (nucleus/cytoplasm) stain contrast is not within limits.
or
The nuclear stain density is not within limits.
or
The chromatin stain contrast is not within limits.
These slides must be screened by a cytotechnologist.
Nuc. Stain - too light or dark
The average stain intensity for the nuclei on this slide is either too light or too dark for reliable
BD FocalPoint™ analysis. Review this slide manually.
These slides must be screened by a cytotechnologist.
Nuc. Stain - chromatin blurring
The average chromatin detail visible in nuclei on this slide is not enough to allow reliable
BD FocalPoint™ analysis. Review this slide manually.
These slides must be screened by a cytotechnologist.
Nuclear stain variation
The stain intensity for nuclei on this slide varies too much to allow reliable BD FocalPoint™
analysis. Review this slide manually.
These slides must be screened by a cytotechnologist.
21.4

Image Quality Not Within Limits

The BD FocalPoint™ Slide Profiler evaluates each slide to verify that it is suitable to be
processed. Physical characteristics of the slide and specimen are analyzed with respect to their
influence on the scanning performance of the instrument. A slide determined by the system to be
unsuitable for analysis is reported as Image quality not within limits with the description of the
failure given as Dust or dirt on coverslip. In some cases it may be possible to clean or reposition
the slide and rerun it. Refer to Section 15.2, for proper usage information to correct these errors.
If the laboratory identifies a subset of slides that cannot be rerun through the device, these slides
must be screened by a cytotechnologist.
The following list describes the reasons for which a slide may be rejected.
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