Isotype Controls

Bruce Davis, MD - Clinical Pathology bdavis at
Fri Mar 29 17:15:18 EST 1996

Although this response should really come from Greg Stelzer, as chair of
the standardization and procedure validation sucommittee of the U.S. FCM
concensus conf for leukemia and lymphoma, I relay the thoughts regarding
isotypes in hematolymphoid malignancies.  Yes, we feel isotype controls
per say as a separate tube is unnecessary for at least 2 reasons.  1)
these are not "normal cells" so CLIA regs for reference ranges are
irrelavent and 2) such studies should contain sufficient numbers of
antibodies that negative markers can substitute for "isotype controls" 
(eg.  in a B cell leukemia - CD4, CD8, CD3, CD7, etc.  can function as
functional negative controls).  On a personal note, I have been following
this practice for over two years and over 1000 leukemias and lymphomas
later and have not had a problem (to my knowledge).

Bruce H. Davis, M.D.
Director of Analytical Cytometry	
Dept. of  Clinical Pathology
William Beaumont Hospital
3601 W. 13 Mile Rd.
Royal Oak, Michigan  48073-6769
FAX 810-551-8057

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