Sophonix Co., Ltd


Sophonix's SARS-CoV-2 IgG and IgM test kit received FDA EUA certificate


Beijing, Sep. 10, 2020---Sophonix Co., Ltd. and its cooperative partner BioCheck, Inc., a privately-held San Francisco-based company focused on in vitro diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the individual BioCheck SARS-CoV-2 IgM Test Kit and the BioCheck SARS-CoV-2 IgG Test Kit which were originally developed by Sophonix.


The reagents are performed on MS-Fast chemiluminescence immunoassay system and are capable of processing human serum samples in 30 minutes to detect antibodies that indicate recent or prior COVID-19 infection.

The SARS-CoV-2 tests target the S1 protein, which has the fewest similarities to other coronaviruses and allows for a lower probability of false positives due to cross reactivity. The S1 protein is also the primary target for the leading COVID-19 vaccine candidates, which are being developed to neutralize antibodies that can block the virus from infecting healthy cells.

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