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Procleix Ultrio Elite Assay

STN# 125652
Proper Name: Procleix Ultrio Elite Assay
Tradename: Procleix Ultrio Elite Assay
Manufacturer: Grifols Diagnostic Solutions, Inc.

Indication:

  • The Procleix® Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test to screen for human immunodeficiency virus type 1 (HIV-1) RNA,hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA, and 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 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. This assay is not intended for use on cord blood specimens.
  • 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. 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).
  • This assay is not intended for use as an aid in diagnosis of infection with HIV-1, HIV-2, HCV or HBV. The Procleix Ultrio Elite Assay can be considered a supplemental test that confirms HIV infection for specimens that are 1) repeatedly reactive on a licensed donor screening test for antibodies to HIV, and reactive on both the Procleix Ultrio Elite Assay and on the Procleix Ultrio Elite HIV Discriminatory Assay and 2) specimens that are repeatedly reactive on a licensed donor screening assay for antibodies to HIV, negative in a minipool with the Procleix Ultrio Elite Assay, and reactive with the Procleix Ultrio Elite HIV Discriminatory Assay.
  • The Procleix Ultrio Elite Assay can be considered a supplemental test that confirms HCV infection for specimens that are 1) repeatedly reactive on a licensed donor screening test for antibodies to HCV, and reactive on both the Procleix Ultrio Elite Assay and on the Procleix Ultrio Elite HCV Discriminatory Assay and 2) specimens that are repeatedly reactive on a licensed donor screening assay for antibodies to HCV, negative in a minipool with the Procleix Ultrio Elite Assay, and reactive with the Procleix Ultrio Elite HCV Discriminatory Assay.
  • The Procleix Ultrio Elite Assay can be considered a supplemental test that confirms HBV infection for specimens that are 1) repeatedly reactive on a licensed donor screening test for HBsAg, and reactive on both the Procleix Ultrio Elite Assay and on the Procleix Ultrio Elite HBV Discriminatory Assay and 2) specimens that are repeatedly reactive on a licensed donor screening assay for HBsAg, negative in a minipool with the Procleix Ultrio Elite Assay, and reactive with the Procleix Ultrio Elite HBV Discriminatory Assay.

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