RAPID ACCELERATION OF DIAGNOTICS (RADX) ADVANCED TECHNOLOGIES PLATFORM RAPID ACCELERATION OF DIAGNOTICS (RADX) ADVANCED TECHNOLOGIES PLATFORM PROJECT

快速诊断加速 (RADX) 先进技术平台 快速加速诊断 (RADX) 先进技术平台项目

• 批准号: 10551013
• 负责人: JAMES LU
• 金额: $ 679.63万
• 依托单位: HELIX
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-30 至 2022-04-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10551013
• 关键词: Acceleration; Address; Advisory Committees; CLIA certified; COVID-19 test; COVID-19 testing; Diagnostic tests; Ensure; FDA Emergency Use Authorization; FDA approved; Industrialization; Laboratories; Logistics; Methods; Monitor; Polymerase Chain Reaction; Process; Public Sector; RADx; RADx Advanced Technology Platforms; Reagent; Reproducibility; SARS-CoV-2 variant; Sampling; Ships; Specificity; Specimen; Technology; Testing; Training; United States National Institutes of Health; Variant; Viral; Viral Genome; design; genome sequencing; laboratory equipment; next generation sequencing; public database; risk mitigation; sample collection; scale up

To enable reopening and monitoring of industrial, educational, and public sectors, widespread diagnostic testing for SARS-CoV-2 is needed. Rapid scale up is required to meet the testing needs in the US. Helix OPCO, LLC will establish an FDA-approved polymerase chain reaction (PCR) SARS-CoV-2 test, under Emergency Use Authorization (EUA), and perform testing in a CLIA-certified laboratory. Testing capacity will be incrementally scaled up to establish a high-throughput laboratory capable of daily processing of 25k, then 50k, then 100k, and finally 150k PCR tests with processing and analysis completed within a day of sample receipt. A subset of samples will undergo full viral genome sequencing, with sequences uploaded to GISAID and other public databases. Characterized samples will be provided to the RADx Variants Task Force to ensure that testing technologies are capable of detecting the full spread of SARS-CoV-2 variants. Expanded testing capacity through an FDA EUA method will support the needs of the US to monitor viral spread, detect variants, and inform reopening and mitigation efforts

为了使工业、教育和公共部门能够重新开放和监测，需要对SARS-CoV-2进行广泛的诊断测试。需要快速扩大规模以满足美国的测试需求。HALGOOPCO，LLC将根据紧急使用授权（EUA）建立FDA批准的聚合酶链反应（PCR）SARS-CoV-2检测，并在CLIA认证的实验室进行检测。检测能力将逐步扩大，以建立一个高通量实验室，每天能够处理25，000次PCR检测，然后是50，000次，然后是100，000次，最后是150，000次PCR检测，并在收到样本后一天内完成处理和分析。一部分样本将进行全病毒基因组测序，并将序列上传到GISAID和其他公共数据库。将向RADx变异体工作组提供表征样本，以确保检测技术能够检测SARS-CoV-2变异体的全面传播。通过FDA EUA方法扩大的检测能力将支持美国监测病毒传播、检测变异并为重新开放和缓解工作提供信息的需求