The highest rated Antigen Test in the world. Easy-to-use with less potential for procedural errors.
The SIENNA™ Ag-RDT presents excellent analytical performances for viral loads ≤33 Ct, classically corresponding to situations of symptomatic COVID-19 and/or proven contagiousness. *
SENSITIVITY
93.8%
SPECIFICITY
99.20%
ACCURACY
98.7%
Approved By The FDA FDA/EUA 04/20/2021
The highest rated Covid-19 IgG/IgM Test
The SiennaTM COVID-19 IgG/IgM Rapid Test Cassette is a membrane-based lateral flow immunoassay intended fo r the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma (dipotassium EDTA, sodium citrate, sodium heparin), venous whole blood (dipotassium EDTA, sodium citrate, sodium heparin) and fingerstick whole blood. The Sienna COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection .
CrossReactivity:
The SiennaTM COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/ Plasma/ Serum) has been tested for anti-influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-H. Pylori, anti-HIV, anti-HCV, ANA and HAMA positive specimens. The results showed no cross-reactivity. Some cross reactivity was observed with samples positive for Rheumatoid Factor. It is possible to cross-react with samples positive for MERS-CoV antibody. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or229E.
