9420 – Point-of-Care-Testing for COVID-19

Nucleic acid amplification techniques are commonly used to diagnose viral diseases and determine when those who are sick remain capable of shedding/transmitting the virus. However, currently available methods are time consuming, and require expensive instrumentation and trained personnel. COVID-19 demonstrates the critical need for rapid Point-of-Care-Testing (PoCT), enabling diagnosis, prevention of transmission, and disease monitoring, in both health-care settings and the workplace. Professor Travis group created a novel diagnostic platform, “TET”, which utilizes enzymes tethered to nanoparticles to detect various disease biomarkers. The team recently completed a successful pilot (n=39 patients) clinical study on TET PoCT-based detection and quantification of a brain injury biomarker with Guthrie Medical Group. In response to the current urgent need, they have modified TET for ultra-rapid (<5 minutes), highly-sensitive, and highly-specific detection of COVID-19 (TET-VirusDX), that is both cost-effective and easy to use. Very exciting new laboratory data show TET-VirusDX can detect clinically relevant quantities of SARS coronavirus Urbani RNA, and distinguish between members of the same virus family, within a few minutes. Clinical data with COVID-19 are critical to advance our “Technology Readiness Level” and move our diagnostic platform to clinical use. They are currently designing clinical pilot studies to test the specificity and sensitivity of TET-VirusDX’s new COVID-19 assay using samples from actual patients. The TET-VirusDX COVID-19 test will be activated by the addition of a liquid sample to a freeze-dried reagent mix, yielding a luminescent signal in the presence of the viral genome. The team intends to use the assay to detect COVID-19 RNA isolated from both nasal swabs and saliva specimens. This will produce sensitivity and specificity data for the two sample types. Note that use of saliva as opposed to deep nasal swabs could provide important benefits for health care workers in terms of reducing their exposure to infectious droplets. If successful, this technology could be used immediately for Point-of-Care detection of virus in sick patients and in asymptomatic individuals. The latter could include both essential employees such as health care workers, as well as personnel in a variety of workplace settings upon future return-to-work scenarios. It could also be used to monitor the status of infection in patients who are known positive, monitor viral load in patients before/during/after treatment, and perform surveillance in epidemiological studies. Because the TET-VirusDX platform can easily be modified to detect different viral pathogens, the studies here will also provide value in advancing testing for other known and emerging viral diseases in the future. Phillip Owh po62@cornell.edu 1-607-254-4508