THE PURPOSE OF THIS MODIFICATION IS TO UPDATE THE DELIVERABLE DUE DATES FOR RADX TECH PROJECT 2200

我们的DASH-HT分子诊断系统将在12分钟内检测无症状受试者的SARS-CoV-2 RNA，通量为每小时30。 样本可以是鼻拭子或鼻咽拭子。 操作员只需不到1分钟的时间即可将样本放入检测盒并扫描条形码。 取出拭子后关闭的检测盒含有提取、纯化和RT-qPCR所需的所有试剂。 在样品制备（需要7分钟）后不到5分钟内进行40个qPCR循环。六个处理单元安装在一个包含电源和环境控制系统的机柜中，因此系统可以全年在室外运行。 它体积小，重量轻，可以作为国内航空公司的托运行李运输。 滤芯设计为在4至30摄氏度的环境温度下稳定至少1年。 它们是信用卡大小的高密度包装。我们的SARS-CoV-2 RT-qPCR检测具有10个拷贝的分析灵敏度，并已与过程控制多重。 Alpha原型目前正在SIGHT研发实验室运行。 他们是最近修改的版本的一个点的护理系统，已在开发3年。 它计划在今年年底进入A/B流感和STI面板的临床试验。 虽然这种高通量版本将立即填补COVID测试的关键空白，但系统可以缩小规模，以满足未来可能涉及的紧急护理诊所和医生办公室的需求。

Our DASH-HT molecular diagnostic system will detect SARS-CoV-2 RNA in asymptomatic subjects in 12 minutes with a throughput of 30 per hour.  Specimens can be nasal or nasopharyngeal swabs.  Less than 1 minute of operator time is required to elute specimens in the cartridge and scan barcodes.  The cartridge, which is closed after removing the swab, contains all reagents needed for extraction, purification and RT-qPCR.  40 cycles of qPCR are performed in less than 5 minutes after sample prep which takes 7 minutes. Six processing units are housed in a cabinet that contains power and environmental control system so the system can be run outdoors year round.  It is small and light enough to be transported as checked luggage on domestic airlines.   Cartridges are designed to be stable for at least 1 year at ambient temperatures of 4 to 30 degrees C.  They are creditcard sized for high density packaging. Our SARS-CoV-2 RT-qPCR assay has  analytical sensitivity of 10 copies, and has been multiplexed with a process control.  Alpha prototypes are currently running in CIGHT R&D labs.  They are recently-modified versions of a point of care system that has been in development for 3 years.  It was scheduled to go into clinical trails with flu A/B and STI panels at the end of this year.   While this high-throughput version will immediately fill a critical gap in COVID testing, systems can be scaled down to meet needs of urgent care clinics and doctors offices that may be involved in the future.