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Healgen Gets FDA Emergency Use Authorization for Coronavirus Immunoassay

NEW YORK — The US Food and Drug Administration on Friday granted Emergency Use Authorization for Healgen Scientific's rapid immunoassay for SARS-CoV-2.

The COVID-19 IgG/IgM Rapid Test Cassette uses lateral flow technology to detect and differentiate immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies against SARS-CoV-23 in venous whole blood, plasma, and serum. The test provides results in 10 minutes and is authorized for use by laboratories CLIA-certified to perform moderate- or high-complexity tests.

Healgen, a subsidiary of China's Zhejiang Orient Gene Biotech, said the test has demonstrated a sensitivity of 97.2 percent and specificity of 100 percent for IgG antibodies, and a sensitivity of 87.9 percent and specificity of 100 percent for IgM antibodies.

Confirm BioSciences, a North American distributor for Healgen, said in a statement on Monday that the COVID-19 IgG/IgM Rapid Test Cassette detects IgM antibodies within three to five days following incubation and IgG antibodies as soon as one to two weeks.