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

Intended purpose

The Alinity i rHTLV-I/II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to HTLV-I and HTLV-II in human serum and plasma including specimens collected post-mortem (non-heart-beating) on the Alinity i analyzer. Performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heartbeating) that have been collected up to 24 hours after death.

Functional description

This assay is a 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.