Hello,

We are currently using diluted albumin as our control for Rh testing. I want to introduce Gamma Clone control made by Immucor since our Anti-D reagent is Gamma Clone. Do I need to validate or do any kind of comparison studies before I go live with the reagent. I am sure manufacturer completed all the studies but, I was wondering if we need to do any testing before I replace our Albumin control with Gamma clone control. Thanks in advance for taking time to answer my question.

I just recently switched from 6% albumin to Immucor's monoclonal control.  I validated it by running a certain number of Rh Positive and Rh Negative patients performing Weak D testing as well.  We also tested it with our Daily QC because we used the 6% albumin as our negative control.  I really debated about the necessity in validating a Control product but decided just to perform a short validation just in case anyone ever asked.

Edited December 4, 20177 yr by mld123

Thank you. Probably, I will do the same .