FDA Issues Emergency Use Authorization for SARS-CoV-2 Serological Test

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization to a serological test which detects antibodies against SARS-CoV-2. The authorization was given to Cellex Inc..

While the precise length of time for which individuals with COVID-19 produce antibodies is still unknown, it is believed the test can diagnose acute or recent SARS-CoV-2 infection.

The test is a lateral flow immunoassay providing the qualitative detection of IgM and IgG antibodies against SARSCoV-2 in serum, plasma, or venipuncture whole blood. Results are obtained in 15 to 20 minutes.

The test is made up of a conjugate pad which contains SARS-CoV-2 recombinant antigens conjugated with colloidal gold and rabbit IgG-gold conjugates, as well as a nitrocellulose membrane strip with an IgG line coated with anti-human IgG, an IgM line coated with anti-human lgM, and a control line which is coated with goat anti-rabbit IgG.

While the FDA has concluded that the benefits of use outweigh the risks, results from the qSARS-CoV-2 IgG/IgM Rapid Test should not be used as the sole basis for diagnosis. Testing is limited to laboratories authorized to perform moderate and high complexity tests.

The FDA has granted several Emergency Use Authorizations for SARS-CoV-2 diagnostics, such as the Xpert Xpress diagnostic, but these have primarily been real-time polymerase chain reaction tests rather than serological assays.

The authorizations apply to the public health emergency declared by the US Department of Health and Human Services over the COVID-19 outbreak.