BK261335- LIAISON® MUREX HIV Ab/Ag HT; LIAISON®XL; LIAISON® diluteX
The FDA has updated information regarding the LIAISON Murex HIV Ab/Ag HT, 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. The assay is intended for use with human serum (with or without gel-SST) or plasma on the LIAISON XL and LIAISON diluteX systems.
This affects the manufacturer of the LIAISON diagnostic platform, clinical laboratories utilizing chemiluminescent immunoassays for infectious disease screening, and regulatory professionals managing HIV diagnostic portfolios.
The availability of simultaneous detection for both HIV antigens and antibodies suggests a streamlined diagnostic workflow for early-stage HIV detection. Professionals in regulatory and laboratory compliance should note the technical specifications regarding sample media (gel-SST vs. standard serum) to ensure proper validation of local testing protocols. This technical update likely pertains to a pre-market notification or a supplement (BK series) for a biologic-related device.
Regulatory and Laboratory teams should update internal diagnostic protocols to reflect the qualitative simultaneous detection capabilities for HIV-1/2 and p24 antigen. Quality units must ensure the specific compatible sample types (serum with/without gel-SST or plasma) are reflected in standard operating procedures.
The LIAISON® 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 Mand0) and HIV-2 in human serum (without or with gel-SST) or plasma.
Open in openFDA / FDA.gov