Device Dossier

Alinity s HTLV I/II Assay - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay

Device Dossier for Alinity s HTLV I/II Assay - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay…

Intended purpose

The Alinity s HTLV I/II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to human T-lymphotropic virus Type I and human T-lymphotropic virus Type II (anti-HTLV I/HTLV II) in human serum and plasma, including specimens collected up to 24 hours postmortem (non-heart-beating), on the Alinity s System.

Functional description

This assay is an automated two-step immunoassay for the qualitative detection of antibodies to HTLV I and HTLV II in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.

TGA Public Summary