We recently had a donor who tested positive for HBV NAT, HCV NAT, HIV NAT. When the tests were repeated individually, they were all negative.

I know there is a draft FDA guidance for HCV NAT and HIV NAT.

I have two questions.

Can we reenter a donor based on a draft guidance,

and what process would we follow for HBV NAT where there isn’t even a draft guidance?

I've also asked this of FDA, I'll post their reply here. I just wanted to see if any blood centers had policies regarding reentry for HBV NAT, HCV NAT, HIV NAT.

Thanks

Cliff,

I spoke with the FDA about reentry using HIV/HCV NAT and was told it would be finalized by the end of 2007. More recently I have read it is nearly ready to be finalized. The author of the draft clearly stated it was not for implementation as a draft document. We do not reenter donors but I do let them know of the pending opportunity to be reentered if applicable

John

Thanks John,

I contacted them and they indicated we could apply for a variance for the donor. The reason we are pursing this is the donor has donated close to 300 pheresis platelets and we hate to lose them.