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Despite major advances in HIV treatment and prevention, accurate and up-to-date diagnostics remain essential for early detection, patient management, and blood screening. Assay design must continuously evolve to ensure reliable detection of both HIV-1 and HIV-2, minimize window periods, and maintain high performance in diverse patient populations.
Hytest supports assay manufacturers by providing high-quality, well-characterized HIV antigen and antibody products for diverse immunoassay platforms. Our portfolio covers key targets such as HIV p24, HIV-1 gp41, HIV-1 gp120, and HIV-2 gp36, enabling sensitive and specific detection of HIV p24 antigen and HIV antibodies in both screening and supplementary tests. As part of this commitment, we are pleased to announce the addition of the HIV-2 antigens 8H24 and 8H25.
Both Cat. # 8H24 and Cat. # 8H25 are recombinant antigens expressed in mammalian cell lines. They are based on the gp36 sequence and cover the major immunodominant regions of the HIV-2 transmembrane protein. This broad epitope coverage ensures robust and sensitive recognition of HIV-2 antibodies with minimal cross-reactivity to HIV-1. An N-terminal HSA tag and a C-terminal His10 tag have been added to the 8H24 protein, while a C-terminal TnC tag and a C-terminal His10 tag have been added to the 8H25 protein to support protein solubility and purification, providing flexible options suitable for various assay formats.
In Hytest’s in-house evaluation of HIV antigens for HIV-2 serology using a CLIA-based assay system, the HIV-2 antigen pairs demonstrated 100% sensitivity when tested with 11 different diluted HIV-2–positive samples. The specificity of the HIV-2 antigen pairs was assessed using various interference and clinical samples and met the performance requirements of Commission Implementing Regulation (EU) 2022/1107 (specificity >99.5%), with three antigen pairs achieving 100% specificity.
For customers developing or updating HIV assays, Hytest offers a broad portfolio of reagents to support assay development, including high-performance HIV p24 antibodies, multiple HIV-1 antigen formats (e.g., gp41 and gp120), and HIV-2 gp36 antigens. For more detailed information, we invite you to watch our HIV webinar recording and download the accompanying presentation slides. These materials provide an in-depth overview of our in-house evaluation studies and practical considerations for assay development.
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