IVD Department Qualitative Antibody Test for HTLV-I/II - Vietnam Registration 2400523ĐKLH/BYT-HTTB

LIAISON XL murex recHTLV-I/II: The LIAISON XL murex recHTLV-I/II test uses CLIA (Chemiluminescent Immunoassay) technology to qualitatively detect antibodies specific to the virus that causes acute T-cell lymphotropic leukemia in humans (Human T-cell Lymphotropic Virus - HTLV) type I and/or type II in human serum or plasma, including samples taken post-mortem (cardiac arrest). The test is used to support the diagnosis of HTLV-I/II infection in individuals, whether symptomatic or asymptomatic. The test is also used to screen blood donors and blood components, as well as organ, tissue, and cellular donors post-mortem. The test is performed only on the LIAISON XL automated immunoassay instrument. LIAISON XL murex Control recHTLV-I/II: The LIAISON XL murex Control recHTLV-I/II (negative and positive) materials are used as quality control samples to monitor the performance and reliability of the LIAISON XL murex recHTLV-I/II test. The performance characteristics of LIAISON XL murex Control recHTLV-I/II have not been established for any other test or instrument system other than the LIAISON XL automated immunoassay instrument.