Thanks for your response, Jose, I agree with your points. I see these guidelines as the first attempt to standardize something that has numerous variables. How can we expect to have the manufacturers of these markers offer (or be required by the FDA) consistent results when our end of this process is "all over the board"? An ER, PR Her2 that we both buy from the same manufacturer should work the exact same way in my lab as it does in yours, IF we both process in the exact same way. I doubt very much if histology and IHC testing will ever be as exact as a clinical chemistry assay for example, but it's a start. I forsee the time gap in formalin shortening as labs get used to this first step. This would mean more validation, but since we should be doing validation each year, then this may not be such a giant task.
Becky Orr CLA,HT(ASCP)QIHC Technical Specialist Anatomic Pathology NorthShore University HealthSystem 847-570-2771 _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
