The IRIS-HIV assay, a point-of-care, multiplex serological assay to identify HIV Infection and Vaccine-Induced Seropositivity

IRIS-HIV 检测是一种即时多重血清学检测，用于识别 HIV 感染和疫苗诱导的血清阳性

• 批准号: 10667353
• 负责人: KIMBERLY LUKE
• 金额: $ 29.99万
• 依托单位: INTUITIVE BIOSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10667353
• 关键词: Acute; Biological Assay; Clinical Trials; Detection; Development; Diagnostic; Diagnostic tests; Feasibility Studies; Goals; HIV; HIV Antigens; HIV Envelope Protein gp120; HIV Infections; HIV vaccine; HIV-1; Human immunodeficiency virus test; Immune response; Individual; Nucleic Acids; Procedures; Sampling; Sensitivity and Specificity; Serology; Serology test; Serum; Vaccines; multiplex detection; point of care; programs; seropositive; specific biomarkers

Development of Diagnostics to Differentiate HIV Infection from Vaccine Induced Seropositivity: Several years of clinical trials have revealed that some HIV vaccines can elicit long-lasting (>15 years) serological immune responses that can be confused with HIV infection in common diagnostic tests. This phenomenon is known as vaccine-induced sero-reactivity or sero-positivity (VISR/VISP). The overarching goal of this program is to support the development of new serological and nucleic acid assays that can identify HIV infection while avoiding false-positive results due to VISP, with high sensitivity and specificity.

区分艾滋病毒感染和疫苗诱导的血清阳性的诊断方法的发展：几年的临床试验表明，一些艾滋病毒疫苗可引起持久（大约15年）的血清学免疫反应，在普通诊断测试中可能与艾滋病毒感染混淆。这种现象被称为疫苗诱导的血清反应性或血清阳性（VISR/VISP）。该项目的总体目标是支持开发新的血清学和核酸检测方法，以高灵敏度和特异性识别HIV感染，同时避免因VISP而导致的假阳性结果。