Table 6.
Interpretation of ISH test results
| HER2/CEP17 ratio | Average HER2 copy number | ISH status interpretation |
|---|---|---|
| < 2.0 | < 4.0 | Negative |
| ≥ 4.0 and < 6.0 | It is recommended to recount 20 cells, and if the result changes, then comprehensively analyze the two results; if the result remains unchanged and the IHC is 2+, it is deemed negative. | |
| ≥ 6.0 | It is recommended to increase the number of counted cells; if the result remains unchanged, it is deemed positive | |
| ≥ 2.0 | < 4.0 | It is recommended to increase the number of counted cells; if the result remains unchanged, it is deemed negative |
| ≥ 4.0 | Positive |
Low HER2 expression means IHC 1+ and/or 2+ and negative ISH.