1 / 6

FDA Perspectives (I)

Parvovirus B19 NAT for Whole Blood and Source Plasma FDA Perspectives and Questions for the Committee Mei-ying W Yu, PhD DH/OBRR/CBER/FDA 75 th Blood Products Advisory Committee. FDA Perspectives (I).

yered
Download Presentation

FDA Perspectives (I)

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Parvovirus B19 NAT for Whole Blood and Source Plasma FDA Perspectives and Questions for the CommitteeMei-ying W Yu, PhDDH/OBRR/CBER/FDA75th Blood Products Advisory Committee

  2. FDA Perspectives (I) 1. For Whole Blood donations, risks to transfusion recipients are sufficient to warrant withholding high-titer individual positive units (³ 106 geq/mL), prior to release of blood components for use in transfusion. • The viremic cutoff level, ³ 106 geq/mL, for positive units, is set to minimize the risk of infection in recipients, to prevent serious consequences of B19 infections in high-risk recipients, and to avoid the removal of low-titer units that may not be infectious and which contain protective antibody

  3. FDA Perspectives (II) 2. A temporary deferral may be warranted for high-titer apheresis donors if positive donations can be resolved within several weeks. • Donation Intervals • 8 weeks for Whole Blood • 8-16 weeks for RBC Apheresis • 48 hours (twice per week) for plateletpheresis • 48 hours (twice per week) for plasmapheresis

  4. FDA Perspectives (III) 3.FDA is seeking the BPAC’s opinion on conclusions made by the Ad Hoc PHS panel that there are sufficient potential medical benefits to close contacts, but not to donors, to warrant notification of parvovirus B19 positive donors. • However, such notification is likely to be useful only in settings where testing and notification can be completed within several (e.g. less than four) weeks of donation.

  5. Questions for the Committee (I) 1. If donations of Whole Blood are tested for the presence of human parvovirus B19, are risks to transfusion recipients sufficient to warrant withholding high titer positive units (³ 106 geq/mL) from use for transfusion? 2. Is temporary deferral of positive donors warranted in the setting of: a. Whole Blood donation? b. Apheresis donation?

  6. Questions for the Committee (II) 3. Do potential medical benefits to contacts of parvovirus B19 infected donors warrant identification and notification of positive donors? 4. If yes to question 3, should donor notification be limited to settings where testing and notification can be completed within several weeks of donation?

More Related