[Histonet] RE: her2 validation

Weems, Joyce JWeems <@t> sjha.org
Wed Mar 31 09:28:42 CDT 2010

>From June-15, 2009 CAP checklist

ANP.22997	Phase I	N/A  YES  NO

If the laboratory performs HER2 testing (HER2  protein over-expression by immunohistochemistry [IHC] or HER2 gene amplification by in situ hybridization [e.g. FISH, CISH*, SISH*, etc.]), has the laboratory documented appropriate validation for the assay(s)?  

NOTE:  Initial test validation must be performed on a minimum of 25 cases (recommended 25-100). Validation may be performed by comparing the results of testing with a validated alternative method (i.e. IHC vs. FISH) either in the same laboratory or another laboratory, or with the same validated method performed in another laboratory; validation testing must be done using the same set of cases in both labs.

If specimens are fixed in a medium other than 10% neutral buffered formalin, the validation study must show that results are concordant with results from formalin-fixed tissues. 

If  significant changes are made in testing methods (e.g., antibody clone, antigen retrieval protocol or detection system, FISH probe or pretreatment protocol), revalidation is required.

This checklist item applies to laboratories that perform the technical testing of specimens for HER2 amplification. Patient specimens should be fixed in the same manner as the specimens used for the validation study(ies).

*CISH =  chromogenic in-situ hybridization; SISH = silver-enhanced in-situ hybridization

Joyce Weems 
Pathology Manager 
Saint Joseph's Hospital 
5665 Peachtree Dunwoody Rd NE 
Atlanta, GA 30342 
678-843-7376 - Phone 
678-843-7831 - Fax 

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