2009
9/18/09
Abbott Prism HIV O Plus becomes second HIV group O screening test approved by the FDA.
08/31/09
FDA releases a guidance document for immediate implementation outlining recommendations for the management of donors at increased risk for HIV-1 group O infection, including an expanded list of countries endemic for HIV-1 group O that should be included in the donor history screening process; recommendations for reporting discontinuance of questions used to identify at-risk donors once an appropriate donor screening test has been implemented; and recommendations for re-entry of donors deferred on the basis of an affirmative response to HIV-1 group O risk questions.
2007
12/10/07
FDA issues a guidance document outlining recommendations for the management of donors at increased risk for HIV-1 group O infection, including a list of high-risk countries that should be included in the donor history questionnaire; recommendations for discontinuing the use of some questions used to identify at-risk donors; and recommendations, criteria and an algorithm for re-entry of previously deferred donors.