Docket Management
Docket: 02D-0096 - Draft Guid.: Use of NAT on Blood From Donors for Transfusion to Reduce the Risk of HIV-1 & HCV
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Mr. Garrick Chatelain Date/Time 2002-04-25 18:44:56
Organization The Blood Center
Category Health Professional

Comments for FDA General
Questions
1. General Comments Continued from comments filed on 2002-04-25 18:04:18 Donor Management: 1) Donors that test positive for HCV or HIV-1 by a licensed NAT assay AND test repeat reactive by a licensed HCV Ab, HIV-1 Ab, or HIV-1/2 Ab assay are to be permanently deferred as a blood donor with no stipulation for re-entry at a later date. 2) Donors that test positive for HCV by a licensed NAT assay but are negative for HCV Ab shall be deferred for a period of twelve-months from the date of the positive donation. After the twelve-month period, the donor may be tested for HCV NAT, HCV Ab, and HCV Ab supplemental testing by licensed kits for re-entry purposes. If all re-entry testing is negative, then the donor may be re-instated as a blood donor. If any re-entry testing is positive, then the donor is permanently deferred. 3) Donors that test positive for HIV-1 by a licensed NAT assay and are negative for HIV-1 Ab or HIV-1/2 Ab shall be deferred for a period of six-months from the date of the positive donation. After the six-month period, the donor may be tested for HIV-1 NAT, HIV-1 Ab by a viral lysate based assay, HIV-1 Ab Western Blot, and HIV-2 Ab by licensed kits for re-entry purposes. If all re-entry testing is negative, then the donor may be re-instated as a blood donor. If any of the re-entry tests are positive, then the donor is permanently deferred. 4) Any donation that yields a repeat reactive HCV Ab result in conjunction with positive HCV NAT result would not require testing by an HCV Ab donor supplemental test (i.e. RIBA). 5) Any donation that yields a repeat reactive HIV-1 Ab or HIV-1/2 Ab result in conjunction with a positive HIV-1 NAT result would not require testing by an HIV-1 Ab donor supplemental test (i.e. Western Blot or IFA). Lookback and product recall: 1) For donors that test HCV or HIV-1 NAT positive by a licensed assay, components produced in the previous 30 days from the collection date of the NAT positive donation should be recalled and destroyed. Receiving facilities should be notified by the blood center within 72 hrs of a NAT positive individual level test. 2) For components that meet the above criteria of being recalled, recipient notification is required. Thank you again for the opportunity to respond.




EC -2