Proper Name: Procleix Ultrio Elite Assay
Manufacturer: Grifols Diagnostic Solutions, Inc.
- Intended to screen for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA and to detect human immunodeficiency virus type 2 (HIV-2) RNA, in plasma and serum specimens from individual human donors, including donors of whole blood, blood components, and source plasma, and from other living donors.
- It is also intended for use in testing plasma and serum specimens to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors.
- It is also intended for use in testing pools of human plasma and pools of human serum composed of equal aliquots of not more than 16 individual specimens from donors of whole blood, blood components, hematopoietic stem/progenitor cells sourced from bone marrow, peripheral blood or cord blood, and from donors of donor lymphocytes for infusion.
- It is also intended for use in testing pools of human plasma composed of equal aliquots of not more than 96 individual donations from donors of source plasma. Plasma and serum specimens from other living donors and from cadaveric (non-heart-beating) donors must be tested using the individual donor testing method only.
- This assay is intended to be used in conjunction with licensed tests for detecting antibodies to HIV-1, HIV-2, HCV, and hepatitis B core antigen, and with licensed tests for hepatitis B surface antigen (HBsAg).