The MicroGEM Sal6830 Point of Care PCR System and SARS-CoV-2 Saliva Test are now available from Medline, a manufacturer and distributor of medical supplies to healthcare providers across the continuum of care, according to a press release from MicroGEM, a molecular biology company based in the United States.
According to the Centers for Disease Control and Prevention, the Omicron BA.5 variant is the primary cause of new cases and hospitalizations in the country, which continues to see an average of more than 100,000 new cases and almost 500 COVID-related fatalities every day (CDC).
“Sal6830 is transforming the ‘new normal’ of living and working with COVID-19 by providing an easy, convenient saliva test that eliminates the discomfort of nasal swabs”, “Medline is a terrific choice as a partner, joining us in sharing the message that ‘sticks up the nose’ can be a thing of the past, and providing their deep and proven technical knowledge, support, and flexibility to quickly respond to customer needs and demands.”
Geoff Stein, Director of Channel Partner Sales for MicroGEM
The Sal6830 makes use of the exclusive point-of-care technology from MicroGEM, which combines enriched intact virus, thermophilic enzymatic RNA extraction, and microscale high-speed RT-PCR to capture complete virus and identify SARS-CoV-2 in less than 30 minutes. Sal6830 is an invaluable tool for quickly and accurately detecting COVID-19 in a variety of settings, including healthcare facilities, movie sets, government and academic facilities, mobile testing sites, retirement homes, and long-term care communities. Sal6830’s non-invasive saliva sampling, clear on-screen instructions, quick on-the-spot results, and portability.
In order to promptly test and protect their workers, visitors, residents, and patients, healthcare organisations and vulnerable communities, such as senior living homes, are in need of the Sal6830, which Medline is well-positioned to offer.
“It is important that we continue to look at new ways to help customers drive efficiency around the ebb and flow of COVID-19 testing”, “Our partnership with MicroGEM expands our product portfolio to offer a saliva-based test for the first time. We expect this to help expand our partnerships with lab leaders to optimize their performance.”
Nicole Krpan, vice president of Medline’s laboratory division
Innovative cartridge design in the Sal6830 SARS-CoV-2 Saliva Testing Kit enables simple addition or replacement of additional targets, resulting in significant time savings for both assay and product development. The company intends to apply for permission to modify the system for the precision medicine healthcare market using quantitative gene expression panels used as biomarkers, as well as to ruggedize it to address harsh field conditions presented in military and disaster medicine use cases.
With large-scale test kit production facilities in Ogden, Utah, instrument production facilities in Hudson, New Hampshire, and R&D pilot manufacturing facilities in Charlottesville, Virginia, MicroGEM has built a U.S.-based supply chain.
The MicroGEM Sal6830 Point of Care PCR System and the MicroGEM Sal6830 SARS-CoV-2 Saliva Test recently received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). These products have been partially funded by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADx®) initiative to hasten the launch of the test with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes
Although the FDA has not certified or approved the MicroGEM Sal6830 SARS-CoV-2 Saliva Test, it has granted authorised laboratories an EUA for emergency use of the test. This product has only been approved to detect the nucleic acid form of SARS-CoV-2; it has not been approved to detect any other viruses or diseases. The declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1), is the only period during which the emergency use of this product is permitted, unless the declaration is terminated or the authorization is revoked earlier.
