Procleix Plasmodium Assay Kit - Multiple Plasmodium species nucleic acid IVD, kit, nucleic acid technique (NAT)

Intended purpose

The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Plasmodium species (P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax) in whole blood specimens. It is intended for use in screening individual human donors, including donors of whole blood and blood components, and in screening living donors of organ and tissue. It is also intended for use in screening cadaveric (nonheart- beating) donors for Plasmodium. It is not intended for use on cord blood specimens. Lysed individual donor whole blood samples are tested either individually or in pools of equal aliquots of not more than 16. Cadaveric donor specimens must be tested individually and not pooled. The Procleix Plasmodium Assay is intended for use on the fully automated Procleix Panther System. The Procleix Plasmodium 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 Plasmodium infection, or as a confirmatory test.

Functional description

The Procleix Plasmodium Assay, which detects the 18S ribosomal RNA of P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax, uses the same target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA) using chemiluminescent technology as other Procleix blood screening assays.