PerkinElmer company EUROIMMUN has introduced the Anti-SARS-CoV-2 QuantiVac ELISA (IgG) test for the quantification of IgG antibodies against the SARS-CoV-2 S1 antigen.

The quantitative assay, which is distributed in countries accepting the CE mark, enables the measurement of SARS-CoV-2 antibodies against viral S1 protein.

EUROIMMUN is also planning to submit an application to secure emergency use authorisation (EUA) from the US Food and Drug Administration for the quantitative test kit.

Features of EUROIMMUN’s ELISA assay

The company’s assay uses a recombinant S1 subunit of the SARS-CoV-2 spike protein for the identification of IgG antibodies.

The ELISA assay will also help to assess a significant antibody subgroup to facilitate standard curve-based quantification of the anti-S1 IgG antibody concentration.

EUROIMMUN stated that it has increased its ELISA production for Covid-19 diagnostics to over three million tests per week.

The company claims to have the required capacity to distribute large numbers of dried blood spot (DBS) collection sets for upcoming seroprevalence and vaccination development studies.

In July, PerkinElmer launched its dry blood spot based test to detect SARS-CoV-2 IgG using its GSP/DELFIA platform, capable of processing up to 5,000 samples per day.

Large international reference laboratories have deployed EUROIMMUN SARS-CoV-2 assays, said the company.

EUROIMMUN CEO Dr Wolfgang Schlumberger said: “The EUROIMMUN assays, especially the S1-based tests, are important tools for pharmaceutical laboratories conducting clinical trials.

“Our assays can help to identify individuals who have been exposed to SARS-CoV-2 and may play a critical role in accurate evaluation of antibody status before and after infection, in antibody therapies or in vaccination programmes.”