Hytest is proud to expand its infectious disease portfolio to support the development of next generation human immunodeficiency virus (HIV) immunoassays – enabling earlier detection and enhancing diagnostic accuracy.
HIV primarily targets CD4+ T lymphocytes. If left untreated, it can lead to acquired immunodeficiency syndrome (AIDS). Early and accurate detection of HIV is critical for treatment, prevention, and curbing transmission.
HIV-specific antibodies are not produced during the acute phase of infection, which poses a significant limitation for traditional immunoassays. To address this, fourth-generation immunoassay was developed to detect acute infection by utilizing a combination of antigen and antibody detection. It detects HIV antibodies and the most abundant protein in HIV virions, p24.
Hytest newly launched HIV p24 monoclonal antibodies (Cat. # 3H24) includes seven high-quality clones (GA12, GA17, GA32, GA34, GA38, GA39, GA54) designed to support the development of HIV p24 antigen immunoassay. These antibodies have been validated on the CLIA platform using the WHO HIV-1 p24 international standard (NIBSC code: 90/636), with recommended pairs achieve an analytical sensitivity of 0.5–0.64 IU/mL - exceeds the requirements set by the EU IVDR Class D regulations. Meanwhile, the specificity of the recommended pairs when testing clinical samples reaches over 99.95%.
We are also proud to confirm that all recommended pairs recognize the WHO International Reference Panel for HIV-1 p24 Antigen (NIBSC code: 16/210) as well as the WHO International Reference Reagent for HIV-2 p26 Antigen (NIBSC code: 16/236).
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For detailed information click here, Human Immunodeficiency Virus Technote.