Handheld RT-PCR System Combined with Saliva-Based Test Brings Mobility to COVID-19 Testing and Reduces Cost

COVID-19 testing has been made easier and more accessible with the US FDA emergency use authorization (EUA) of the combination of SalivaDirect developed by Yale School of Public Health (New Haven, CT, USA) with Ubiquitome Limited’s (Auckland, New Zealand) handheld Liberty16 mobile real time-PCR.

SalivaDirect was developed to reduce access challenges inherent in nasal swab based COVID-19 testing. Saliva samples collected for testing by SalivaDirect do not require healthcare worker assistance, preservatives, or specialized equipment for nucleic acid extraction. SalivaDirect is now used in more than 120 US labs designated by Yale. It has also been authorized for sample collection using the Unsupervised Collection Kit (for sample drop off) and SalivaDirect At-Home Collection Kit (mail-in testing), as well as in asymptomatic individuals.

Ubiquitome’s Liberty16 RT-PCR system was one of the only international companies selected by the US National Institutes of Health’s RADx initiative to speed innovation and commercialization of technologies for COVID-19 testing. The Liberty16 is designed to bring mobility to PCR testing and reduce cost. The PCR is handheld, can run on battery power and connects to its own iPhone app, which shows the result of tests to operators easily trained to run the Liberty16 and the iPhone app. In its filing with the FDA, the Yale team demonstrated the singleplex SalivaDirect protocol performed on the Liberty16 yielded test results for SARS-CoV-2 comparable to bigger, immobile instruments. Collecting saliva samples, analyzing them in the Liberty16 and getting the result spelled out on the iPhone app, allows for outbreaks to be identified anywhere there is cell phone reception, by labs with SalivaDirect authorization.

“That’s important for quickly limiting the spread of COVID-19 when the alternative is waiting sometimes days for results as the nearest testing laboratory is hours away,” said Dr. Paul Pickering, CEO of Ubiquitome. “With Liberty16 units costing a fraction of the large, lab-based units, it means access to RT-PCR testing can be improved for millions of people in under resourced communities.”

Related Links:
Ubiquitome Limited
Yale School of Public Health