IVD Department qualitative test for the p24 antigen of HIV-1, HIV-1 (M, O) antibodies and/or HIV-2 antibodies - Vietnam Registration 2400227ĐKLH/BYT-HTTB

LIAISON XL murex HIV Ab/Ag HT: The LIAISON XL murex HIV Ab/Ag HT test uses the CLIA (Chemiluminescent Immunoassay) technology to qualitatively determine the p24 antigen of the Human Immunodeficiency Virus type 1 (HIV-1) and quantitatively determine the specific antibodies against both types of HIV-1 (group M and group O) and/or type 2 (HIV-2) in human serum or plasma. The LIAISON XL murex HIV Ab/Ag HT test is used in the diagnosis of HIV-1/ HIV-2 infection and in the screening of blood or plasma donors. The test is performed only on the LIAISON XL automated immunoassay instrument. LIAISON XL murex Control HIV Ab/Ag HT: The LIAISON XL murex Control HIV Ab/Ag HT (negative and positive for HIV-1 antibodies and p24 antigen of HIV) is used in the CLIA (Chemiluminescent Immunoassay) LIAISON test to assess the reliability of test runs. The performance characteristics of the LIAISON XL murex Control HIV Ab/Ag HT have not been established for any other test or system other than the LIAISON XL automated immunoassay instrument.