0850032683Procleix00878 - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Intended purpose

The Procleix UltrioPlex E 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, hepatitis B virus (HBV) DNA, and hepatitis E virus (HEV) RNA 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 (non-heart-beating) donors. This assay is not intended for use on cord blood specimens. The Procleix UltrioPlex E Assay is intended for use on the fully automated Procleix Panther System. The Procleix UltrioPlex E Assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the operation of the Procleix Panther System and in vitro diagnostic procedures. This is a first line assay and is not intended for use as an aid in diagnosis of infection with HIV-1, HIV-2, HCV, HBV, or HEV, or as a confirmatory test.