Diagnostic solutions company Biodesix has commercially introduced the SARS CoV-2 neutralisation antibody test, dubbed cPass Neutralisation Test Kit.

The test, which is from GenScript, uses ELISA technology for the identification of circulating neutralising antibodies against the receptor-binding domain (RBD) of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus).

The cPass test is claimed to be the first and only surrogate neutralising antibody test with FDA emergency use authorisation (EUA).

Neutralising antibodies produced by the body’s immune system are expected to block the interaction between the receptor-binding protein on SARS-CoV-2 and the host cell’s membrane receptor protein. It will help prevent infection of the cell by the virus.

Biodesix SARS CoV-2 neutralisation antibody test can identify the presence or absence of an important subset of antibodies, which arise after previous infection or vaccination in individuals.

The presence of neutralising antibodies will help healthcare providers to understand whether an immunised individual is positive or negative for SARS-CoV-2 neutralising antibodies.

Biodesix CMO Dr James Jett said: “Surveillance programs incorporating the cPass SARS CoV-2 Neutralization Antibody Test could broadly inform the presence or absence of neutralising antibodies in previously infected or vaccinated individuals in these higher-risk populations.

“This test is also highly applicable for research studies aimed at understanding the immune correlations of protection in the face of previous infection or vaccination. This information could also be useful in planning for potential immunisation boosters.”

Biodesix stated that it is the first company to provide seven non-invasive tests for patients with diseases of the lung.

The company is also now offering the Bio-Rad SARS-CoV-2 ddPCR and the Platelia SARS-CoV-2 Total Ab tests.