[Histonet] Validation of Her2

[Vickroy, Jim]

We are working on validating HER 2 testing in our laboratory.  I see that the guidelines state that we should use 25 - 100 cases to complete our validation.
In the past we sent our Her2 IHC testing to Clarient and they performed the technical testing and then our pathologists would do the scoring.  So for validation we used 25 of the cases we sent to Clarient and then did them in house to compare.   Our comparison was nearly 100%.  Here is my question:

Clarient uses the DAKO method while we are using Ventana's antibody Pathway (4B5).   The validation guidelines state "parallel by identical method in another lab with the same validated assay is also acceptable".  Can I assume that this means comparison with another lab for IHC HER2 testing and does not have to be using the same clone (DAKO vs Ventana)?

Jim

James Vickroy BS, HT(ASCP)

Surgical  and Autopsy Pathology Technical Supervisor
Memorial Medical Center
217-788-4046


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