Dutch Ridge Consulting Group (DRCG), LLC, a Service-Disabled, Veteran-Owned Small Business (SDVOSB) headquartered in Beaver, PA, announces that the FDA has approved a CLIA-waiver for the Sienna™ COVID-19 IgG/IgM Rapid Test Cassette.
DRCG offer this effective, low-cost method for the rapid diagnosis of both early marker and late marker, IgM/IgG antibodies in a human finger-prick. It is fast with results in under 15 minutes, easy to administer, and does not require a prescription. In addition, Sienna™ COVID-19 IgG/IgM Rapid Test Cassettes are produced in Europe and certified to ISO 13485:2016 (unlike many of the similar competitive products from China), which complies with the Federal Government’s Executive Order to reduce US reliance on China regarding essential medicines, medical supplies, and equipment.
A high percentage of individuals show no clinical symptoms of the virus. This test gives organizations an effective way to screen and protect their people. The test is effectively being administered in medical facilities, businesses, schools, etc., by qualified medical personnel, making it an essential tool in the fight against the global pandemic.
The Sienna™ COVID-19 IgG/IgM Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human fingerstick whole blood, venous whole blood, serum, or plasma as an aid in identifying patients with an adaptive immune response to SARS-CoV-2 indicating recent or prior infection. It has been authorized by the FDA under an Emergency Use Authorization for use by authorized laboratories.
DRCG is ready to ship kits immediately – with bulk order discounts available.
For more information contact us at RapidCovidTest@drcg.us.