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

为了重新开放和监测工业、教育和公共部门，需要广泛进行SARS-CoV-2诊断检测。需要迅速扩大规模以满足美国的检测需求。Helix OPCO， 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测试，并在clia认证的实验室进行测试。测试能力将逐步扩大，以建立一个高通量实验室，能够每天处理25k，然后是50k，然后是100k，最后是150k PCR测试，并在收到样品后一天内完成处理和分析。一部分样本将进行完整的病毒基因组测序，并将序列上传到GISAID和其他公共数据库。特征样本将提供给RADx变体工作组，以确保测试技术能够检测到SARS-CoV-2变体的全面传播。通过FDA EUA方法扩大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

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