Fast-breaking News from AABB PulsePoints The following has been reproduced from the June 23, 2005 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

June 23, 2005
No. 701

West Nile Virus Final Guidance

AABB PulsePoints

The Food and Drug Administration (FDA) issued final guidance titled, “Guidance for Industry:Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection” on June 23, 2005. This guidance finalizes the draft guidance issued April 2005, and revises the previous guidance, dated May 2003. The guidance applies to blood and blood components intended for transfusion and blood components intended for use in further manufacturing into injectable products or non-injectable products, including recovered plasma, Source Leukocytes and Source Plasma.The guidance does not apply to human cells, tissues, and cellular and tissue based products that are subject to 21 Code of Federal Regulations (CFR) part 1271.

Significant changes to the draft guidance include a recommendation to defer donors suspected of having West Nile virus (WNV) infection or diagnosed with WNV infection for 120 days after diagnosis or onset of illness, whichever is later.

The guidance also recommends that donors be deferred on the basis of a reactive investigational screening test for WNV. At their discretion, blood establishments may re-enter such donors after 120 days from the date of their reactive donation. Additional testing of the donor during the recommended 120-day deferral period is not recommended. However, the guidance does note that individual donation testing using a nucleic acid test (IDT NAT) for WNV on a follow-up sample, obtained during the 120-day deferral period, may provide useful additional scientific information on the duration of WNV viremia in donor, and stipulates that if such a follow-up sample is reactive for WNV, the donor should be deferred for an additional 120 days from the date the sample was collected.

The deferral periods specified in the guidance are based on a 14-day asymptomatic incubation period and a 120-day potential viremic period, which include all known observations of prolonged viremia plus an additional margin of safety.

Also new, is a recommendation for retrieval and quarantine of in-date components of relevant collections from a presumptive viremic donor, (donor who has tested reactive for WNV infection using the investigational WNV NAT donor screening test). Relevant collections include those occurring between 120 days prior to the date of the reactive test and 120 days after the date of the reactive test.

The revised recommendations in this guidance may be applied prospectively, i.e., actions taken under previous guidance do not need to be reconsidered subject to the additional provisions of this guidance.

The guidance provides recommendations for donor deferral, retrieval and quarantine of blood and blood components, including recovered plasma, Source Plasma and Source Leukocytes, notification of prior transfusion recipients, biologic product deviation and fatality reporting, and labeling of products distributed for research or intended for further manufacturing into non-injectable products.These changes do not require prior approval of FDA.

The guidance should be implemented as soon as possible but not later than 30 days after issuance of this guidance. Licensed establishments implementing these recommendations must submit a statement in their annual report indicating the date that the revised standard operating procedures were implemented.

For more details including an extensive background section, visit http://www.fda.gov/cber/guidelines.htm#westnile.

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