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Fluorescence in Situ Hybridization (FISH): Equivocal Results
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Fluorescence in Situ Hybridization (FISH): Equivocal Results
The
CURRENT
equivocal range for FISH assays are defined as HER2/CEP17 ratios from <2.0 with an average HER2 copy
≥
4.0 and <6.0 signals/cell.
Patients with a HER2/CEP17 FISH ratio between 1.8 - 2.2 were formerly considered HER2-positive and were eligible for treatment in the adjuvant trastuzumab trials.
Equivocal results of a single test (IHC or FISH) require additional action. The same specimen can be used for an alternate test or a new test can be performed (new specimen using same or alternate test).
Equivocal IHC samples must be confirmed by FISH analysis of the sample.
Equivocal FISH samples are confirmed by counting additional cells or repeating the FISH test.
If FISH remains equivocal after additional cells counted or assay repeated, confirmatory IHC is recommended so that HER2 protein expression is known for the sample with true equivocal gene amplification.
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