Rapid at-home Detection for Serologic Status of Hepatitis C Virus (HCV) Infection

在家快速检测丙型肝炎病毒 (HCV) 感染的血清学状态

• 批准号: 10709149
• 负责人: HONG QI
• 金额: $ 40万
• 依托单位: QOOLABS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-19 至 2023-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10709149
• 关键词: Affect; Antibodies; Antibody Response; Antigens; Biological Assay; Blood specimen; Caring; Chronic Hepatitis C; Code; Conserved Sequence; Country; DNA Sequence; Detection; Development; Diagnosis; Epitopes; Fingers; Genotype; Health; Hepatitis C; Hepatitis C Antibodies; Hepatitis C virus; Home; Human; Immunoassay; Income; Individual; Infection; Lateral; Link; Oryctolagus cuniculus; Performance; Persons; Polyproteins; Population; Process; Proteins; RNA Viruses; Recombinants; Risk Factors; Sampling; Sensitivity and Specificity; Sequence Alignment; Serology; Serum; Symptoms; Temperature; Testing; Time; United States; anti-hepatitis C; antibody detection; cost effective; design; detection limit; detection test; effective therapy; end stage liver disease; home test; instrument; liver transplantation; performance tests; protein expression; rapid test; screening; seroconversion; stability testing; test strip; virus core

Hepatitis C Virus (HCV) infection is a worldwide health concern, affecting about 3% of the world’s population. Over 2 million people in the United States have a current HCV infection, however, nearly half of them are not aware of their infection. HCV-related end stage liver disease is the leading reason for liver transplantation in the USA. Because symptoms are generally absent in individuals with chronic HCV infection, appropriate HCV testing must be linked with risk factors to allow for recognition of infection. Effective treatments for HCV infection are currently available. However, diagnosis is a bottleneck for appropriate HCV care and treatment, especially in low- and medium-income countries. In this project, Qoolabs proposes to develop at-home rapid test for HCV antibody detection The test will use finger prick blood samples, can be completed within 20 minutes without special instrument. The HCV antibody at-home test will be complementary with the HCV core antigen rapid tests that are being developed. With both core antigen and total antibody detection, it is feasible to achieve accurate and cost-effective at-home serodiagnostics to fulfill the need of screening large populations.

丙型肝炎病毒(丙型肝炎病毒)感染是一个世界性的健康问题，影响着世界约3%的人口。美国目前有200多万人感染了丙型肝炎病毒，但其中近一半人并不知道自己感染了丙型肝炎病毒。丙型肝炎病毒相关的终末期肝病是美国肝移植的主要原因。由于慢性丙型肝炎病毒感染者通常没有症状，因此适当的丙型肝炎病毒检测必须与危险因素联系起来，以便识别感染。目前已有治疗丙型肝炎病毒感染的有效方法。然而，诊断是适当的丙型肝炎护理和治疗的瓶颈，特别是在低收入和中等收入国家。 在这个项目中，QOOLABS建议开发家庭快速检测丙型肝炎病毒抗体的方法，该检测将使用手指刺血样本，可以在20分钟内完成，而不需要特殊的仪器。家庭中的丙型肝炎病毒抗体检测将与正在开发的丙型肝炎病毒核心抗原快速检测相辅相成。同时检测核心抗原和总抗体，实现准确和经济的家庭血清诊断是可行的，以满足大规模人群筛查的需要。