Point-of-care diagnostic for amplification and detection of SARS-CoV-2 RNA

用于扩增和检测 SARS-CoV-2 RNA 的即时诊断

• 批准号: 10324780
• 负责人: Karl Gorzelnik
• 金额: $ 26.06万
• 依托单位: LYNNTECH, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-02 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10324780
• 关键词: 2019-nCoV; Bacterial RNA; Benchmarking; Biological Assay; COVID-19 detection; Dengue; Detection; Development; Devices; Diagnostic; Early identification; Enzymes; Equipment; Exhibits; Genome; Gold; Guide RNA; Home; Human; Human Resources; In Situ; Individual; Laboratories; Laboratory Diagnosis; Measures; Mediating; Methods; Monitor; Nucleic Acids; Paper; Phase; Process; RNA; RNA amplification; RNA purification; RNA-Directed RNA Polymerase; Regulatory Affairs; Reproducibility; Reverse Transcription; SARS-CoV-2 infection; Saliva; Sampling; Signal Transduction; Small Business Innovation Research Grant; Specificity; System; Testing; Text; Time; Training; Validation; Virus; Virus Replication; Work; ZIKA; amplification detection; assay development; base; detection limit; detection platform; diagnostic assay; fight against; improved; lateral flow assay; method development; novel strategies; particle; pathogenic virus; point of care; point-of-care diagnostics; replicase; saliva sample; viral RNA

PROJECT SUMMARY Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged in late 2019 and has rapidly spread around the world. We propose the development of a diagnostic assay that will exhibit a low limit of detection of SARS-CoV-2 via a unique viral RNA amplification process. By developing a method to enrich viral RNAs over eukaryotic or bacterial RNAs we can lower the limit of detection and potentially reduce the level of false positives and negatives observed when using RT-based diagnostics. As this method is specific for viral RNA in general, it will can be used for other human ssRNA viral pathogens, such as Zika or Dengue. The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be the development of a new step in viral RNA detection, usable for detecting SARS-CoV-2, but also other ssRNA viruses. By using an isothermal approach to amplify viral RNA our device will eliminate the need for expensive equipment, which increases access to testing. The proposed work will validate the specificity of the enzyme toward viral RNAs, develop a system to extract and detect these RNAs, and lower the detection limit for POC or at-home diagnostics.

项目摘要 严重急性呼吸系统综合征冠状病毒2型（SARS-CoV-2）于2019年底出现，并迅速 传播到世界各地。我们建议开发一种诊断测定法，该测定法将表现出低限度的 通过独特的病毒RNA扩增过程检测SARS-CoV-2。通过开发一种方法来富集病毒 我们可以降低检测限，并潜在地降低RNA水平。 使用基于RT的诊断时观察到的假阳性和假阴性。由于该方法对病毒具有特异性 一般来说，它可以用于其他人类ssRNA病毒病原体，如寨卡病毒或登革热。的 这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力将是 病毒RNA检测新步骤的开发，可用于检测SARS-CoV-2，但也可用于检测其他ssRNA 病毒通过使用等温方法来扩增病毒RNA，我们的设备将消除对 昂贵的设备，这增加了测试的机会。拟议的工作将验证的特异性， 针对病毒RNA的酶，开发一种提取和检测这些RNA的系统，并降低检测 POC或在家诊断的限制。