spavlis Posted October 15, 2007 Share Posted October 15, 2007 Does anyone know if it is OK to test HCT/P's for NAT HIV and HCV testing in mini-pools? I have heard that recently the FDA has approved the testing of HCT/P's for NAT HIV and HCV in pools on the Roche Molecular Systems and Gen- Probe. Though, I still haven't seen any changes in the January FDA guidance " Certain Human Cells, Tissues, and Cellular and Tissue-Based Products Recovered from donors who were tested for communicable diseases using pooled specimens or diagnostic tets". Are we suppose to wait for the FDA to change the wording on this FDA guidance before implementing the testing in pools? thanks stephanie Link to comment Share on other sites More sharing options...
RR1 Posted October 29, 2009 Share Posted October 29, 2009 Anyone able to help with this?thanks! Link to comment Share on other sites More sharing options...
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