Procleix Ultrio Elite assay - HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Intended purpose

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and human immunodeficiency virus type 2 (HIV) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors tested individually or in pools. It is also intended for use in testing plasma and serum to screen organ and tissue donors, including cadaveric (nonheart-beating) donors. This is a first-line assay and is not intended for use as an aid in diagnosis or as a confirmatory test. For use by qualified clinical laboratory personnel.

Functional description

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test intended for use on the fully automated Procleix Panther System.