MicroGEM ‘s enrichment matrix captures whole virus. A novel thermophilic enzyme achieves RNA extraction. Microfluidic movement allows extracted RNA to be converted to cDNA and detected by RT-PCR amplification.
In the United States, the MicroGEM Sal6830 SARS-CoV-2 Saliva Test is authorized for emergency use by the FDA under Emergency Use Authorization (EUA) at the Point of Care (POC) 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.
CLIA Certificates of Waiver are issued for technologies so simple and accurate that the likelihood of an erroneous result is negligible and there is no unreasonable risk of harm. Find out more about CLIA waivers and how to apply.
September 2022: Workflow Services by ImageMover Joins Forces with MicroGEM to Provide Workflow Solution for Fast SARS-CoV-2 Testing at Point of Care
August 2022: One-of-a-Kind Telehealth Solution for Saliva PCR SARS-CoV-2 Testing at the Point of Care now Available through MicroGEM and AiTmed
August 2022: Military Officials Tour Wise Free Clinic: Sal6830 is there
August 2022: Medline and MicroGEM Partner to Equip Healthcare Providers with World's First Saliva PCR Test for Point of Care
August 2022: MicroGEM Provides Fast, On-site PCR Test for Large-scale DOD-Supported Medical Event Serving Vulnerable Communities
July 2022: MicroGEM Partners with Government Scientific Source to Bring Fast Saliva PCR Test to Government Agencies
July 2022: MicroGEM and Songbird Life Science Partner to Bring Fast COVID-19 Saliva PCR Test to Industries Across the U.S.
July 2022: Industry Veteran Thomas Scientific Now Offering MicroGEM's Innovative Sal6830 Fast Saliva RT-PCR COVID-19 Test
June 2022: MedTech Selects MicroGEM as a Top 50 Startup
April 2022: MicroGEM Granted Emergency Use Authorization from FDA for Fast Point of Care PCR COVID-19 Saliva Test
August 2022: New Saliva-Based PCR Test for COVID-19 Hopes to End Nasal Swabs (Forum Daily News)
August 2022: New Saliva-Based PCR Test Has Been Authorized by Health Canada (IHeartRadio Podcast 27:00 - 33:00)
August 2022: Saliva-based COVID-19 PCR Test Authorized by Health Canada (CTV News)
July 2022: Goodbye Nasal Swabs! First Fast PCR Saliva COVID-19 Tests for Point of Care Conducted in Canada
July 2022: As Nation Braces for Seventh Wave, Health Canada Authorizes World's First Saliva Point of Care PCR Test to Quickly Detect SARS-CoV-2
Paper copies of all user documents are available upon request at firstname.lastname@example.org.
MicroGEM and Workflow Services by ImageMover have partnered to provide state-of-the-art COVID-19 test result management. This optional fully-integrated reporting platform automates data reporting requirements and simplifies the delivery of test results.
Learn more here.
To add the Sal6830 SARS-CoV-2 reporting solution to your Sal6830 PCR system, go to www.microgembio.com/covid-19/order.
For more information, reach out to our sales team at www.microgembio.com/covid-19/contact.
If you have questions or need additional information please contact us.