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

金标SARS-CoV-2检测(100%特异性，100%敏感性)已于2020年2月4日通过FDA CDA实时PCR检测在美国推出，但许多需要它的美国人仍然无法获得它。最近使SARS-CoV-2检测更容易进行的尝试(例如雅培和奎德尔)一直受到低吞吐量(一次一个样本)和高假阴性的困扰。需要的是疾控中心™S授权的金标准实时聚合酶链式反应检测，每个美国人都能接触到。我们建议对我们的商业移动Liberty16系统进行快速增强和扩展计划，使这一全移动实时聚合酶链式反应设备超过集中式实验室中基于吞吐量的黄金标准96孔工作流程，同时提供与CDC测试相同的低假阴性水平(&lt；5%)。增强的功能。我们将快速实施几个计划中的功能，这些功能大大增强了现有Liberty16系统的吞吐量和用户界面功能：(1)实现了能够单井检测多个目标的多路复用能力。这将每次运行的样本容量从3个增加到14个(加上控制)。(2)实施软件和硬件的微小修改，将运行时间从40分钟大幅减少到25分钟或更短。(3)更新Liberty16 iPhone/iPad用户界面，包括(I)用于样品识别符输入的条形码阅读器；(Ii)多路分析的自动报告功能。(4)优化安全的唾液样本采集和准备工作流程，使设置在5分钟内完成，处理步骤最少。

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.