A Multifunctional Point of- Care Platform to Differentiate HIV Infection from Vaccine Induced Seropositivity

区分 HIV 感染和疫苗引起的血清阳性的多功能护理点平台

• 批准号: 10927087
• 负责人: RANIER NG
• 金额: $ 30万
• 依托单位: BAEBIES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10927087
• 关键词: Address; Antibodies; Binding; Biological Assay; Contracts; Development; Diagnostic; Goals; HIV Infections; HIV-1; Human immunodeficiency virus test; Immunoassay; Infection; Laboratories; Molecular; Nucleic Acids; Reverse Transcription; Sampling; Sensitivity and Specificity; Serology; Testing; Vaccines; clinical practice; diagnostic platform; next generation; novel diagnostics; point of care; programs; self testing; seropositive

Development of Diagnostics to Differentiate HIV Infection from Vaccine-Induced Seropositivity: 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 vaccine-induced seropositivity (VISP), with high sensitivity and specificity. These next generation assays should be developed to address one or all applications/indications of HIV tests, namely: (1) laboratory based tests; ((2) point-of-care and clinical practices; and (3) self-testing. This contract aims to develop a novel diagnostic platform that automates a HIV-1 qualitative reverse transcription PCR (RT-PCR) test together with two direct antibody binding assays to differentiate HIV-1 infection from VISP.

开发区分HIV感染与疫苗诱导血清阳性的诊断方法：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，这些方法可以识别HIV感染，同时避免由于疫苗诱导血清阳性（VISP）而导致的假阳性结果，具有高灵敏度和特异性。应开发这些下一代检测试剂盒，以解决HIV检测的一种或所有应用/适应症，即：（1）基于实验室的检测;（2）护理点和临床实践;以及（3）自我检测。该合同旨在开发一种新型诊断平台，该平台可自动进行HIV-1定性逆转录PCR（RT-PCR）检测以及两种直接抗体结合检测，以区分HIV-1感染和VISP。