COVID-19 IgG/IgM Rapid Testing
lateral flow immunoassays for the diagnosis of coronavirus infection.
Sienna™ COVID-19 IgG/IgM Rapid Test Cassette.
- Effective, low-cost method for the rapid diagnosis of Covid-19 infection
- Fast, easy to administer, and results in under 15 minutes
- Rapid screening of carriers of the virus that are symptomatic or asymptomatic
- No prescription required
- Detects both early marker and late marker, IgM/IgG antibodies in human finger-prick or venous blood samples
- 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
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. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 42 U.S.C. 263a to perform high complexity tests.
This test has been authorized by FDA under an Emergency Use Authorization use by authorized laboratories.