RAPID AND SENSITIVE IDENTIFICATION OF HIV ANTIGEN AT THE POINT OF USE

在使用时快速、灵敏地鉴定 HIV 抗原

• 批准号: 8603499
• 负责人: KUMAR SUBRAMANIAN
• 金额: $ 19.62万
• 依托单位: PHOENIX BIOSYSTEM, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-24 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8603499
• 关键词: AIDS/HIV problem; Acute; Algorithms; Antibodies; Antigens; Award; Binding; Biological Assay; Buffers; Clinical Chemistry; Communicable Diseases; Complex; Consultations; Detection; Developing Countries; Discrimination; Disease; Doctor of Medicine; Generations; Grant; HIV; HIV Antibodies; HIV Antigens; HIV Core Protein p24; HIV Infections; HIV diagnosis; Health; Health Personnel; Immunoassay; Incidence; Individual; Infection; Label; Laboratory Research; Medical; Medicine; Methods; Microfluidics; Microspheres; Milk; Monitor; Patients; Performance; Plasma; Proteins; Protocols documentation; RNA; Reagent; Research; Resources; Role; Run-On Assays; Sampling; Schedule; Scheme; Serological; Serum; Signal Transduction; South Africa; Specimen; Surface; System; Technology; Test Result; Testing; Time; Whole Blood; assay development; base; cost effective; density; design; disorder control; disorder prevention; global health; human subject; new technology; nucleic acid detection; point of care; professor; programs; public health relevance; screening; success

DESCRIPTION (provided by applicant): The success of HIV antibody tests in narrowing the window period of HIV diagnosis has been notable. However, immunoassays designed to detect antibody alone will not be able to identify individuals with acute infection who have not yet begun to produce HIV-specific antibodies. Attempts to detect acutely infected individuals have mostly involved RNA detection algorithms used on pooled HIV antibody-negative specimens. However, the use of RNA-based detection methods is expensive, laborious, and can be operationally daunting. An alternative to the detection of acute HIV infections using RNA-based methods is to utilize antigen-antibody combination tests, also known as "fourth-generation" immunoassays. Fourth-generation immunoassays have recently been cleared by FDA for use in the US. These fourth generation assays have multiple shortcomings: a) the detection limits for p24 antigen is still not low (~ 15 pg/mL) and b) the assays are run on large, expensive, cumbersome and time-consuming clinical chemistry analyzers. The assay results are not immediately available to the patient. The specific aim of this proposal is to, develop a reliable, accurate, cost-effective Point-of-care (POC) ultra-sensitive quantification of HIV p24 antigen with detection limits in range of sub pg/mL. This test could significantly reduce the serological window for detection of HIV and provide results to the patient in a timely manner.

描述（由申请人提供）：HIV 抗体检测在缩小 HIV 诊断窗口期方面取得的成功是显着的。然而，仅用于检测抗体的免疫测定法无法识别尚未开始产生 HIV 特异性抗体的急性感染个体。检测急性感染个体的尝试主要涉及对合并的 HIV 抗体阴性样本使用 RNA 检测算法。然而，使用基于 RNA 的检测方法昂贵、费力，而且操作起来令人畏惧。使用基于 RNA 的方法检测急性 HIV 感染的另一种方法是利用抗原抗体组合测试，也称为“第四代”免疫测定。第四代免疫测定法最近已获得 FDA 批准在美国使用。 These fourth generation assays have multiple shortcomings: a) the detection limits for p24 antigen is still not low (~ 15 pg/mL) and b) the assays are run on large, expensive, cumbersome and time-consuming clinical chemistry analyzers.患者无法立即获得化验结果。该提案的具体目标是开发一种可靠、准确、经济高效的 HIV p24 抗原即时护理 (POC) 超灵敏定量方法，检测限在亚 pg/mL 范围内。该检测可以显着缩短艾滋病毒检测的血清学窗口，并及时向患者提供结果。