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.
June 2022: MedTech Selects MicroGEM as a Top 50 Startup
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)
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.