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

金标准SARS-CoV-2检测（100%特异性，100%灵敏度）已于2020年2月4日在美国通过FDA CDA实时PCR检测提供，但许多需要它的美国人仍然无法获得。最近使SARS-CoV-2检测更容易获得的尝试（例如雅培和奎德尔）一直受到低通量（一次单个样本）和高假阴性的困扰。我们需要的是每个美国人都能接触到的cdc<e:1> FDA授权的黄金标准实时PCR检测。我们建议对我们的商用移动Liberty16系统进行快速增强和扩展计划，这将使这种完全移动的实时PCR设备超过集中式实验室中基于通量的96孔金标准工作流程，同时提供与CDC测试相同的低假阴性水平（<5%）。增强的功能。我们将快速实现几个计划中的功能，这些功能将大大提高现有Liberty16系统的吞吐量和用户界面：(1)实现多路复用功能，实现单井探测多个目标。这将每次运行的样本容量从3个增加到14个（加上对照）。(2)实施软件和小的硬件修改，将运行时间从40分钟显著减少到25分钟或更少。(3)更新Liberty16 iPhone/iPad用户界面，包括(i)用于样本标识符输入的条形码阅读器；（ii）多重分析的自动报告。(4)优化唾液的安全样品收集和制备工作流程，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.