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.
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.
Obtain Saliva Sample
Connect Cup to Cartridge
Insert and Run Test
Sal6830 SARS-CoV-2 Saliva Test
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.
Dr. Teresa Tyson, DNP, MSN, FNP-BC, FAANP and CEO
The Health Wagon
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.
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.
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.
The Sal6830 Mobile Workstation is an optional accessory to deliver portable testing to point-of-need locations.
To find out more about going mobile with the Sal6830 Mobile Workstation, contact us.