Quansys Biosciences has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG antibody test.

The laboratory-based IgG Q-Plex SARS-CoV-2 Human IgG (4-Plex) assay has been developed to simultaneously identify human IgG antibodies, which recognise the S1 and S2 subunits of the SARS-CoV-2 spike protein from the same sample.

Benefits of IgG antibody test

A positive IgG antibody result enables to efficiently detect patients who have been exposed to the SARS-CoV-2 virus. The test showed an adaptive immune response, as part of the patient’s recovery, said Quansys.

The S1 subunit consists of the receptor-binding domain required for viral entry into human cells and the viral domain associated with neutralising antibodies.

According to the company, the accuracy of testing for the S1 subunit alone was sufficient for EUA requirements and the addition of the S2 subunit measurement to the clinical call increased accuracy to 97.4% sensitivity and 99.7% specificity.

Quansys stated that its technical team will support sites adopting the assay to quickly attain optimal capacity.

Quansys Biosciences CEO Adam Brown said: “High quality tests are essential as we work to better control the SARS-CoV-2 pandemic. In addition, improved quality and accuracy of the assay is vital to correctly evaluate the spread of this virus, which varies across communities.”

In April this year, Quansys first announced the introduction of the SARS-CoV-2 Human IgG(4-plex) enzyme-linked immunosorbent assay (ELISA) to help detect the novel coronavirus responsible for the Covid-19 disease.

Established in 2005, the company is engaged in the development and manufacturing of customised multiplex ELISA kits for researchers, vaccine and drug developers, and government agencies.