Clinical Flow Guru's, I have a question regarding testing of ASR's. I know that we are now required to denote analyte specific reagents as being properly tested and we are doing this, but I want to know what others consider proper testing. For instance, if you have a CD8 antibody that is not IVD approved how do you go about proving that the antibody is adequate for use? Is staining your CD8 against CD3 and CD4 to prove that the CD8 cells are CD3+ and CD4- enough? If so what are resonable deviations (1% of CD8's also stain CD4 and 5% of CD8's are CD3-)? Do you have to sort the CD8's and prove they are lymphocytes and then do you have to show proof your sorter works? How does this work with an antibody against CD13 or TdT where it is difficult to find any IVD antibody to test it against? Is using normals sufficient or should you test against normaI and abnormal (clonogenic)? I guess what I want to know is how far is far enough and what are other people doing. Any thoughts, advice or comments appreciated. Brian Newsom Director, Flow Cytometry Center for Cell and Gene Therapy Baylor College of Medicine
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