Leica Biosystems Bond Oracle HER2 IHC System - Manual (Page 8)

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Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
9. Enter details for the first case. Ensure the dispense volume is set to 150 µL and the
preparation protocol is *Dewax. Click OK.
10. With the case highlighted in the Slide setup screen click Add slide.
11. First, add patient test slides. Ensure tissue type is set to Test tissue.
12. Confirm the dispense volume is 150 µL and the preparation protocol is *Dewax.
13. Select staining mode values Single and Oracle (do not click Oracle control).
14. Select process IHC.
15. Select *HER2 Negative Control from the marker list. The Protocols tab defaults to the correct
staining protocol (*IHC Protocol H) and HIER protocol (*HIER 25 min with ER1 (97)).
16. Click Add slide. The negative control reagent slide is created.
17. Still in the Add slide dialog, select *HER2 Primary Antibody from the marker list. Default
protocols and all other settings remain unchanged.
18. Click Add slide. The test slide is created.
19. Repeat steps 8 to 18 until all cases and patient test slides have been created.
20. Next, create the HER2 Control Slide. Add it to the last case or create a new case for
control slides, depending on your standard laboratory practises.
Important note: It is a requirement of the Bond Oracle HER2 IHC System that a HER2 Control Slide is
included in each run (ie slide tray) in order to validate the assay.
21. In the Add slide dialog set tissue type to Positive tissue.
22. Click Oracle control.
23. Select the lot number of the HER2 Control Slide in the Lot No list. The lot number is
inscribed on the label area of the slide.
Important note: The HER2 Control Slide must come from the same Bond Oracle HER2 IHC System that will
be used.
24. Select *HER2 Primary Antibody from the marker list. Retain dispense volume, staining
mode, process and protocol settings.
25. Click Add slide to add the HER2 Control Slide.
26. Finally, add a positive in-house tissue control slide.
27. Deselect Oracle control.
28. Select *HER2 Primary Antibody from the marker list. Retain dispense volume, staining
mode, and process and protocol settings. Tissue type remains Positive tissue.
29. Click Add slide. This completes slide creation.
30. Print slide labels. All Oracle slide labels have “OC” printed on them. The label for the
HER2 Control Slide also includes the Bond Oracle HER2 IHC System lot number.
31. Label slides appropriately.
32. Open the lids of all Bond Oracle HER2 IHC System containers and load the reagent tray
onto the BOND.
33. Place slides onto the slide tray in the order indicated in section D, Table 2. Apply new
Covertiles.