Testing people for SARS-CoV-2 (COVID-19) has just been made easier and more accessible with United States Food and Drug Administration (FDA) emergency use authorization (EUA) of the combination of SalivaDirect™ with Ubiquitome’s Liberty16 mobile real time-PCR.
SalivaDirect was developed by a Yale School of Public Health team, headed by ex-pat New Zealander Dr Anne Wyllie, 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 specialised equipment for nucleic acid extraction.
Dr Wyllie was approached early in the pandemic by the US National Basketball Association and its players’ association to validate the saliva-based protocol in asymptomatic individuals. SalivaDirect is now used in more than 120 US labs designated by Yale.
It has also been authorised 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.
Dr Wyllie says she realized early in the pandemic that there was no reason for SARS-CoV-2 tests to be so expensive. SalivaDirect then became a public health driven ‘mission’. The team conducts its validation work at no cost to labs and does not charge agreement or licensing fees.
“However, costly instruments for real-time PCR analysis often stand in the way of equitable access for under resourced communities and countries and sustainability of testing systems,” Dr Wyllie says.
Public health officials throughout the world have expressed concern about inequities in the COVID-19 response. Recently, the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme (IOAC) called on the international community to reduce the socioeconomic impacts of the global pandemic.
Dr Wyllie says she saw potential for the Liberty16 RT-PCR system. New Zealand-based Ubiquitome 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.
Dr Paul Pickering, CEO of Ubiquitome, says collecting saliva samples, analysing 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 authorisation.
“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.
“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.”
Yale researcher Devyn Yolda-Carr, who has led many bridging studies to expand the SalivaDirect protocol to labs and their equipment, says the Liberty16 presents an affordable solution to the access problem without compromising performance.