Device Generic Name: Test, HIV Detection (Human Immunodeficiency Virus (HIV) p24 antigen and Antibodies to HIV Type 1 (HIV-1 group M and group O) and/or Type 2)
Tradename: LIAISON XL MUREX HIV Ab/Ag HT and LIAISON XL MUREX Control HIV Ab/Ag HT
Manufacturer: DiaSorin, Inc.
- The LIAISON® XL MUREX HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum (without or with gel-SST) or plasma (lithium and sodium heparin, sodium citrate, and potassium EDTA), on the LIAISON® XL Analyzer.
- It is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection.
- The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (2-21 years) and in pregnant women.
- The assay cannot distinguish between the detection of HIV p24 antigen and HIV-1/HIV-2 antibodies.
- The LIAISON® XL MUREX Control HIV Ab/Ag HT is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL HIV Ab/Ag HT assay. The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® XL.
- The LIAISON® XL MUREX HIV Ab/Ag HT assay is not intended for screening donors of blood or blood products, or human cells or tissues or cellular and tissue-based products (HCT/Ps), or organ donors for HIV.
- Summary of Safety and Effectiveness -LIAISON XL MUREX HIV Ab/Ag HT and LIAISON XL MUREX Control HIV Ab/Ag HT
- November 25, 2020 Approval Order - LIAISON XL MUREX HIV Ab/Ag HT and Control HIV Ab/Ag HT