MicroGEM’s Sal6830 SARS-CoV-2 Saliva Test (U.S.) and Sal6830 SARS-CoV-2 Saliva Testing Kit (Canada)
(hereafter Sal6830 saliva test) provide the first-of-their-kind PCR-based saliva test for fast, simple,
on-the-spot detection of COVID-19 infection not possible until now.
Together with the MicroGEM Sal6830 Point of Care PCR System (U.S.) and Sal6830 SARS-CoV-2 Saliva Testing
System (Canada) (hereafter Sal6830 system), the Sal6830 saliva test gives people timely answers about their
health status, allowing them to quickly return to regular activities or immediately isolate and get care.
Saliva samples are non-invasive, making them more comfortable and easier than nasal swabs.
Easy to use in workplaces and portable for on-the-spot testing.
Simple workflow and on-screen instructions for results in under 30 minutes.
Proprietary point-of-care technology captures intact virus, an important indicator of infection.
United States: The MicroGEM Sal6830 SARS-CoV-2 Saliva
Test is authorized for use under FDA Emergency Use Authorization (EUA) only. It is authorized for use at
the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver,
Certificate of Compliance, or Certificate of Accreditation. The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is
also authorized for laboratories certified under the clinical Laboratory Improvement Amendments of 1988
(CLIA), 42 U.S.C. §263a, that meet the requirements to perform, high, moderate or waived complexity tests.
More Sal6830 FDA EUA regulatory information can be found here.
Canada: The Sal6830 SARS-CoV-2 Saliva Testing Kit is
authorized for sale and importation in Canada pursuant to section 5 of the Interim Order respecting the
importation and sale of medical devices for use in relation to COVID-19.
Eliminate the need for uncomfortable swab testing.
A quick and painless sampling method that increases testing compliance among subjects of all ages.
Ideal for testing children or individuals who are uneasy with getting swabbed or find swab
Reduces the workload for healthcare workers
Limits healthcare worker exposure, therefore decreasing the risk of viral transmission to other
Resistant to Global Supply Shortages
Does not require any additional materials to carry out a test. Simply “pool and flow” saliva into
the Saliva Collection Cup (provided with the test) and screw on the cap. Done.
Tough on Variants
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test has been clinically validated during both
Delta and Omicron waves.
We see many patients who are anxious about nasal swabs so we are excited about the opportunity to
offer saliva testing. If patients are comfortable providing the sample and quickly get their results, then
they are more likely to be receptive to ongoing care and future testing. Sal6830 is also a nice fit for
our mobile labs with a workflow easily administered by our staff, giving us the ability to provide care
to patients within minutes of results.
The Sal6830 system uses on-the-spot RT-PCR to quickly detect intact virus using easy-to-collect saliva
samples, allowing fast decision-making about a person’s possible infectivity.
It means quicker decisions to help people resume normal activities if they test negative, or isolate and get
care if they test positive.
It means contact tracing for positive people can begin immediately, not days later.
It means healthcare professionals can put often limited resources to work where they are most needed.
Fast Real-time results in minutes
Saliva-Based Easy to collect - no invasive swabs; a reliable sample for detecting SARS-CoV-2
Easy Simple workflow with on-screen step-by-step guidance
High Performance Enrichment matrix captures intact virus; RT-PCR provides high sensitivity
Point-of-Need Simple to
operate, battery or plug-in, enables immediate decisions
Sal6830 PCR-based Saliva Testing When and Where It’s Needed
In today's 'new normal', where activities are resuming among vaccinated and unvaccinated
people, testing can help relieve the burden and anxiety about who is sick and infectious.
Sal6830: a game-changing addition to COVID-19 testing in our communities.
Testing remains a key strategy to end this pandemic.
Point-of-care tests are done in the presence of the patient so there is no downtime while waiting for a
lab to process the result. In the case of Covid-19, this means a person either immediately gets treatment
or can get on with their lives.
Sal6830 saliva-based RT-PCR testing can help identify COVID-19 cases in a matter of minutes -- with the
confidence of a molecular test and the speed of an antigen test.
The innovative design of the Sal6830 SARS-CoV-2 saliva test targets both the E and N genes on SARS-CoV-2,
reducing the risk of current and future variants affecting the efficacy of the test.
While we are optimistic that the COVID-19 pandemic will subside, we remain committed to ensuring that people
have access to high-quality COVID-19 RT-PCR tests with quick results. Our Sal6830 is a fast, innovative
solution for today and the future.