Одобрен подтверждающий тест на наличие ВИЧ и вируса гепатита С у доноров крови
The Food and Drug Administration on Dec. 9 (2009) approved additional claims for the Procleix Ultrio assay and a labeling change for the package insert. This in vitro nucleic acid assay is used for screen-ing donated whole blood and blood components for human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA. The FDA determined that it can be used as a supplemental test “to confirm HIV-1 and/or HCV infection in specimens that are repeat reactive in a licensed donor screening test(s) for antibodies to HIV-1 and/or HCV,” according to the announcement on the FDA Web site, www.fda.gov. The full, revised package insert is available at http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/UCM092120.pdf.