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Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013
denaturation time is recommended.
• No difference in amplication status was observed when the hybridization time was performed
for 9 hours and 15 hours when compared to the default Leica HER2 FISH System - 30
Test protocol. Highest quality ratings were observed at the default time of 12 hours and this
hybridization time is recommended.
• No difference in amplication status was observed when the post hybridization wash time
was performed for 2 minutes, 5 minutes, and 7 minutes, when compared to the default Leica
HER2 FISH System - 30 Test protocol. Highest quality ratings were observed at the default
time of 4 minutes and this post hybridization wash time is recommended.
• No difference in amplication status was observed when the Leica HER2 FISH System - 30
Test was performed at 28 °C and 30% relative humidity and 16 °C and 80% relative humidity,
when compared to the default Leica HER2 FISH System - 30 Test protocol performed at
ambient conditions.
Operations performed outside of the tested assay robustness recommended parameters have
not been validated. The use of any other testing parameter may invalidate the assay.
The above text describes the conditions tested and the results from the study. Note that Leica
did not test all possible combinations of conditions and does not recommend using non-default
ranges for all conditions. The default Leica HER2 FISH Staining Protocol is outlined in Table 2.