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

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.