May 19, 2021Erica Tennenhouse, PhD
Last March, the World Health Organization (WHO) declared the crucial role of COVID-19 testing for public health. “The most effective way to prevent infections and save lives is breaking the chains of transmission. And to do that, you must test and isolate. You cannot fight a fire blindfolded,” WHO director-general Dr. Tedros Adhanom Ghebreyesus said at a briefing.
Since early on in the pandemic, COVID-19 testing has primarily served to identify those who have been infected and inform their treatments, and also to track how the virus has moved through populations. But lately, there’s been a shift in testing.
Getting back to normal
These days, talks around diagnostics center on how testing will hasten the recovery of pre-pandemic activities. Public testing is becoming a key strategy to get pupils back to school, employees back to work, and people travelling and attending events again. “We’re seeing this transition from testing to track the virus to testing to gain admittance into a place or event,” says Scott Rabuka, the senior director of molecular products at DNA Genotek.
With these new impetuses driving testing, the burden of testing is making its way from the health care arena into the public arena. But public testing comes with its own challenges.
The problem with nasopharyngeal swabs
Consider back-to-school testing. Children are a particularly tough sell when it comes to traditional nasopharyngeal swabs. Even prior to the pandemic, DNA Genotek’s vice president of innovation Rafal Iwasiow, says researchers around the world were well aware of the public’s aversion to this method of sampling: “The common thread among researchers was once you do a nasopharyngeal swab, you’re never going to do one again—it’s just the discomfort level.”
After more than a year of COVID-19 testing primarily done via nasopharyngeal swabs, society as a whole has adapted and people will generally get the swab if it’s needed. But Iwasiow notes that the invasive swabs can still serve as a deterrent.
Fortunately, while the notion that nasopharyngeal swabs are the best way to test for COVID-19 has been prevalent since the beginning of the pandemic, studies are now showing that they are simply one of a handful of effective options. And when it comes to mass public testing, there is a more desirable alternative available.
Saliva as a solution
Saliva testing for COVID-19 is becoming increasingly popular as mass public testing gains ground. The main benefits of saliva testing in the public arena are that it is noninvasive and comfortable for the person being tested, it’s easy to do, a health care professional isn’t needed to obtain the sample, and it’s possible to collect samples from a lot of people in a short amount of time with it.
Consequently, vendors have been scrambling to get saliva testing kits for COVID-19 to the market. But the technology existed long before the pandemic hit.
A tried and tested saliva collection device
DNA Genotek, for instance, has been developing saliva testing products for more than a decade. The company was founded by a researcher at the University of Ottawa, Canada, who realized that the white blood cells in saliva were an excellent source of DNA. He developed chemistries to lyse those cells, expose their genomic DNA, and stabilize it for years at ambient temperature.
From that base technology, DNA Genotek has iterated their chemistry to create other products that extract RNA, microRNA, viral RNA, and microbial DNA from saliva. So, when the pandemic came around, the company was able to respond quickly by tweaking their existing RNA stabilizing chemistry. Their OMNIgene•ORAL device for collecting DNA from saliva uses the same collection format that was already FDA 510(k) cleared for human genomics testing (Oragene®•Dx), so obtaining an emergency use authorization on the device for COVID-19 was a relatively simple process.
The fact that the device was already being used for research purposes prior to the pandemic meant that the company had a head start in developing comprehensive instructions, which are crucial for end users. Even though saliva samples are arguably easier for individuals to self-collect than nasopharyngeal swabs, the process is still prone to error, which can result in the need to recollect. DNA Genotek’s years of experience and data to support proper use avoids wasted time and samples.
The company recently formed its viral screening and surveillance group to serve the enormous need for testing during the pandemic. But the group is also gearing up for the future. “We think post-COVID, there’s still going to be this paradigm of testing for respiratory infections,” says Rabuka.
Benefits of the OMNIgene•ORAL for public COVID-19 testing include:
- Non-invasive sample collection.
- Consumer-safe components.
- Easy self or assisted collection by anyone, anywhere.
- SARS-CoV-2 RNA stabilization at ambient temperature, eliminating the need for cold chain transport.
- Greater than 99 percent viral inactivation, allowing safe sample handling.
- High-throughput processing.
- FDA and other regulatory authorizations in place.