A luciferase immunoprecipitation system-based ultra-sensitive assay for HIV-1 p24 IgG in serum.

The human immunodeficiency virus type 1 (HIV-1) continues to pose a major global public health burden. However, progress in curbing the HIV pandemic is slowing, with the annual number of new infections remaining persistently high globally. HIV-1 p24 antigen-specific antibodies serve as the most consistent and robust markers for early HIV-1 seroconversion. Thus, the development of ultra-sensitive p24 IgG detection methods is of clinical and epidemiological significance. In this study, an assay for the detection of HIV p24-specific IgG in serum was established using the luciferase immunomagnetic system (LIMS), with the incorporation of a humanized Gaussia luciferase (hGLuc)-p24 chimeric antigen. Under optimized conditions, the assay enables semi-automated processing of 32 clinical serum samples within 15 min, with a minimal sample volume of only 2.5 μL per test. Compared to conventional enzyme-linked immunosorbent assay (ELISA), the HIV-1 p24 LIMS assay not only streamlines the experimental workflow but also exhibits superior sensitivity, a wider dynamic range for signal detection, and enhanced discrimination between positive and negative specimens. These integrated advantages render the assay particularly valuable for scenarios demanding rapid, accurate and high-throughput diagnostic responses to HIV-1 infection.