RADX TECH PROJECT #4554: UBIQUITOME SARS-COV-2 LAB TEST ACCURACY WITHIN REACH OF EVERY AMERICAN WITH LIBERTY16 MOBILE REAL TIME PCR

RADX 技术项目

• 批准号: 10505996
• 负责人: PAUL PICKERING
• 金额: $ 176万
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-29 至 2021-09-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10505996
• 关键词: 2019-nCoV; American; Americas; Bar Codes; COVID-19 testing; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Computer software; Detection; Devices; Gold; Minor; Modification; Preparation; RADx Tech; Reader; Reporting; Running; Saliva; Sampling; Specificity; System; Testing; Time; Update; base; multiplex assay; programs; sample collection

Gold standard SARS-CoV-2 testing (100% specificity, 100% sensitivity) has been available in America February 4, 2020, through the FDA CDA real time PCR test, yet it is still not available to many Americans who need it. Recent attempts to make SARS-CoV-2 testing more accessible (e.g. Abbott & Quidel) has been plagued by low throughput (single sample at a time) and high false negatives. What is needed is the CDC’s FDA authorized gold standard real time PCR testing within reach of every American. We propose to engage in a rapid enhancement and scaling program for our commercial mobile Liberty16 system that will allow this fully mobile real time PCR device to exceed the throughput- based gold standard 96-well based workflows in centralized labs while offering the same low false negative levels (<5%) observed with the CDC test. Enhanced Functionality.  We will fast-track implemetation of several planned features that substantially enhance the throughput and user interface of the exisiting Liberty16 system: (1) Implementation of multiplex capability enabling single-well detection of multiple targets. This increases sample capacity from 3 to 14 (plus controls) per run. (2) Implementation of software and minor hardware modifications that significantly reduce the run time from 40 minutes to 25 minutes or less. (3) Update the Liberty16 iPhone/iPad user interface to include (i) a barcode reader for sample identifier input; (ii) automated reporting of multiplexed assays. (4) Optimize a safe sample collection and preparation workflow for saliva, enabling setup completion in under 5 minutes and with minimal processing steps.

金标准SARS-CoV-2检测（100%特异性，100%灵敏度）已于2020年2月4日在美国上市，通过FDA CDA真实的时间PCR检测，然而，许多需要它的美国人仍然无法获得它。（例如Abbott & Quidel）一直受到低通量（一次单个样品）和高假阴性的困扰。我们需要的是CDC的FDA授权的黄金标准真实的时间PCR检测，每个美国人都可以得到。我们建议对我们的商业移动的Liberty 16系统进行快速增强和扩展计划，这将使这种完全移动的真实的时间PCR装置超过集中实验室中基于通量的黄金标准96孔工作流程，同时提供与CDC测试相同的低假阴性水平（<5%）。增强功能。我们将快速实施几项计划功能，这些功能将大幅增强现有Liberty 16系统的吞吐量和用户界面：（1）实施多重功能，实现单井检测多个目标。这将每次运行的样本容量从3个增加到14个（加上质控品）。(2)对软件和硬件进行微小修改，将运行时间从40分钟显著缩短至25分钟或更短。（3）更新Liberty 16 iPhone/iPad用户界面，以包括（i）用于输入样本标识符的条形码阅读器;（ii）自动报告多重检测。(4)优化唾液的安全样本采集和制备工作流程，使设置在5分钟内完成，处理步骤最少。