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 -1

Accepted - Volume 1

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

Comments for FDA General
Questions
1. General Comments Thank you for the opportunity to comment of this draft guidance. The guidance in it's current format does not provide any information on product management or donor management. In addition, there is no attempt to correlate NAT results with other currently licensed viral marker tests (HCV Ab, HIV 1/2 Ab, or HIV-1 p24 Ag). The provision to eliminate the HIV-1 p24 Ag test appears to dependent upon a NAT manufacturer's claim, therefore, that will not be addressed in these comments. Here are my proposed amendments to the guidance document: Product Management: 1) All components that are derived from donors are implicated in NAT positive pool are to be quarantined during resolution testing of the primary pool. 2) Facilities may release components after the completion of the second tier of resolution testing in accordance with manufacturer package inserts even if individual resolution has not been completed. 3) Components derived from a donor that tests positive for either HCV or HIV-1 by a licensed NAT test at the individual testing level shall be destroyed in accordance with state and federal biohazardous regulations. Donor Management:




EC -1