Can we use the CAP HER2 IHC Survey proficiency samples that provide FISH data for our initial test validation to show acceptable concordance with FISH or a validated IHC system?
No, the concordance studies must be done, if possible, on tissues that have been processed in your own laboratory. For initial IHC test validation, labs must show at least 95% concordance between their IHC results and the results of testing the same blocks either by a validated FISH assay or by sending the same blocks to another lab performing HER2 by a previously validated IHC method. Validation studies must be done on 25 to 100 cases including non-immunoreactive (0 or 1+)/non-amplified (<1.8 HER2/CEP 17) and immunoreactive (3+)/amplified (>2.2 HER2/CEP 17) samples. While the testing guidelines do not specify a specific minimum number of cases for each category, approximately equal numbers of HER2(+) and HER2(-) cases should be studied. If fewer than 20 cases in either category are tested, concordance must be perfect to achieve at least 95% concordance. For validation study purposes equivocal findings reported by the reference laboratory should be removed from the data set and not con
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