Device Dossier

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

Device Dossier for ARCHITECT rHTLV-I/II assay - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay…

Intended purpose

The ARCHITECT rHTLV-I/II assay is a chemiluminescent microparticle immunoassay (CMIA) 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 ARCHITECT analyser. Performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heart beating) that have been collected up to 24 hours after death.

Functional description

A Chemiluminescent assay for the qualitative detection of HTLV-I and HTLV-II in human clinical specimens.

TGA Public Summary