Jane12 Posted December 4, 2017 Share Posted December 4, 2017 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. Link to comment Share on other sites More sharing options...
mld123 Posted December 4, 2017 Share Posted December 4, 2017 (edited) 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, 2017 by mld123 Marianne 1 Link to comment Share on other sites More sharing options...
Jane12 Posted December 6, 2017 Author Share Posted December 6, 2017 Thank you. Probably, I will do the same . Link to comment Share on other sites More sharing options...
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