NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for Salofa's SARS-CoV-2 lateral flow immunoassay.
The Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette is designed to detect immunoglobulin G (IgG) and M (IgM) antibodies against SARS-CoV-2 in human serum, plasma, and venous whole blood. Results are available within 10 minutes.
It is authorized for use by an lab CLIA-certified to perform moderate- or high-complexity tests, the FDA said.
According to the Finnish company, the test was evaluated in a number of studies including one conducted at the National Cancer Institute in June in which sensitivity and specificity for IgM antibodies were estimated at 90 percent and 100 percent, respectively. Sensitivity and specificity estimates for IgG antibodies in the study were 93.3 percent and 98.8 percent, respectively.
Salofa was founded in 2013 and manufactures and markets IVD products and medical tubing.