English – Leica Biosystems HER2 FISH System - 30 Test User Manual
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Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013
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Figure 1: Interpretation Guide
Leica HER2 FISH System - 30 Test Interpretation Guide
Count as 2 orange signals and 1 green signal
Do not count. Nuclei with no signals or with signals of only 1 color
should not be scored. Only score those nuclei with one or more
FISH signals of each color
Count as 1 orange signal and 2 green signals
Count as 3 orange signals and 2 green signals
Count as 5 orange signals and 4 green signals. 1 orange signal is
diffuse and 1 green signal is diffuse
Count as 4 orange signals and 2 green signals. 1 orange signal is
diffuse. Count 2 signals that are the same size and separated by
a distance equal or less than the diameter of the signal, as one
signal
Count as 5 orange signals and 3 green signals. 1 orange signal is
diffuse
Count as 2 orange signals and 2 green signals. 1 orange signal and
1 green signal are overlapping
Do not count. The nuclei are overlapping. It is too difficult to tell
which nuclei the signals are located in
Count as approximately 16 orange signals and 2 green signals