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 | | Unlike the use in donor counseling, if a licensed Western blot has been performed as the additional, more specific test for reentry purposes, additional IFA testing may not be used to negate or resolve a positive or indeterminate Western blot result. |
 | | For example, if a licensed western blot test result is indeterminate, whether on the initial, substituted, or follow-up sample, a negative IFA result obtained subsequently is not sufficient to qualify a donor for reentry. |
 | | The results of additional testing on the donor sample by either IFA or Western blot may be provided to the consignees of such products as a basis for the decision to trace and notify recipients of previously collected units from currently positive donors. |
| www.fda.gov /Cber/bldmem/042392.txt (970 words) |
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