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HistoCore
SPECTRA
H&E Staining System
S1
3801654
S2
3801655
Protocol Adjustments
The validated HistoCore SPECTRA H&E Staining System S1/S2 protocols comes pre-loaded on the HistoCore SPECTRA ST and
will default to a dial setting of 4 for both the Hematoxylin and Eosin. Only the Hematoxylin and Eosin times may be adjusted when
using these staining systems. All other protocol steps and times outlined in Table 1 are fixed. To adjust the staining intensity of the
Hematoxylin and/or Eosin, use the Dial Settings in Table 2 below.
Readiness for Use
Once the HistoCore SPECTRA H&E Staining System is placed onto the HistoCore SPECTRA ST Stainer, the system is ready to be used.
If any reagent vessels that contain stain components or ancillary reagents are marked out with a red X on the bathlayout screen,
this is an indication that the corresponding reagent vessel in the instrument is not ready to be used. Confirm that the reagent vessel
is in the correct location in the instrument and the fill level of the reagent is sufficient in the reagent vessel. After confirming, repeat
the fill level scan by selecting the Fill Level Scan button on the bathlayout screen. For further troubleshooting, refer to the HistoCore
SPECTRA ST Instructions for Use.
Quality Control
A routine quality control slide(s) containing tissue fixed and processed in a similar manner to the test specimens should be performed
prior to routine use to ensure reagents are performing as intended.
Expected Results
By following the instruction for use, a single HistoCore SPECTRA H&E Staining System S1/S2 can provide a maximum of 1,600 stained slides
as based on internal performance characteristics. The components of the stain system will stain cell nuclei blue and color the connective
tissue, cytoplasm, muscle and erythrocytes various shades of orange, pink and red.
Analytical Performance
The HistoCore SPECTRA H&E Staining System is not used to detect a specific analyte or marker. The system is used to stain cell nuclei
blue and connective tissue, cytoplasm, muscle and erythrocytes various shades of orange, pink and red. Analytical parameters such
as analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from
trueness and precision), limits of detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate
criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference, cross-reactions
do not apply to the performance of this system.
Clinical Performance
The HistoCore SPECTRA H&E Staining System is not intended for use as a means of detecting a specific disease or pathological process
or state. Clinical performance indices such as diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive
value, likelihood ratio as well as expected values in normal and affected populations do not apply to the use of the HistoCore SPECTRA H&E
Staining System in a clinical setting.
Disposal
The HistoCore SPECTRA Staining System should be disposed in accordance with local governing regulations.
Table 2: Dial Settings
Hematoxylin Dial Settings
Setting
Timing (mm:ss)
Dial 1
1:00
Dial 2
2:00
Dial 3
3:00
Dial 4
4:00
Dial 5
5:00
Dial 6
6:00
Dial 7
7:00
Dial 8
8:00
Dial 9
9:00
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Eosin Dial Settings
Setting
Timing (mm:ss)
Dial 1
0:30
Dial 2
1:00
Dial 3
1:30
Dial 4
2:00
Dial 5
2:30
Dial 6
3:00
Dial 7
3:30
Dial 8
4:00
Dial 9
4:30
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