Leica TA9217 사용자 설명서

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Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013

To determine the LSI HER2 to CEP17 ratio, use the following method:
1.  Record and determine the number of LSI HER2 and CEP17 signals in 20 nuclei (see 

Figure 2 Leica HER2 FISH System - 30 Test score sheet below).

2.  Total all of the LSI HER2 signals. This represents the total LSI HER2 signals for the count, 

e.g. 143.

3.  Total  all  of  the  CEP17  signals.  This  represents  the  total  CEP17  signals  for  the  count,  

e.g. 48.

4.  To calculate the final result, use the following calculation: 

Total LSI HER2 signals divided by Total CEP17 signals,  

e.g. 143/48 equals a ratio of 2.98, which is positive for HER2 amplification.

additional 20 nuclei and recalculate the ratio.
Results should be reported as follows:

1.  If the ratio is <2, HER2 gene amplification was not observed
2.  If the ratio is ≥2, HER2 gene amplification was observed