FDA grants EUA for Roche’s test to measure SARS-CoV-2 antibody levels

3 December 2020 (Last Updated December 3rd, 2020 11:59)

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Roche’s immunoassay, Elecsys Anti-SARS-CoV-2 S antibody test, for the in vitro determination of antibodies to SARS-CoV-2.

FDA grants EUA for Roche’s test to measure SARS-CoV-2 antibody levels
The test provides a numerical result on the antibody concentration, ranging from 0.40-250U/ml. Credit: Ahmad Ardity / Pixabay.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Roche’s immunoassay, Elecsys Anti-SARS-CoV-2 S antibody test, for the in vitro determination of antibodies to SARS-CoV-2.

Elecsys can measure the level of antibodies in people, who are exposed to the SARS-CoV-2, with a blood sample.

The serology test targets antibodies that are directed against the spike protein, which helps the virus to attach to a host cell receptor. The binding enables the virus to enter the host cell.

Tests that measure antibodies to the spike protein could be used for calculating the response level and tracking that measurement over time, Roche said.

In addition, the test provides a numerical result on the antibody concentration, ranging from 0.40-250U/ml, and a qualitative result.

Known as convalescent plasma therapy, the investigational procedure separates and removes the plasma from a patient’s blood.

The plasma is then replaced with a donor’s plasma in order to give antibodies to the ill patient to fight the virus.

Roche Diagnostics CEO Thomas Schinecker said: “Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against Covid-19.

“Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response.”

The test can be used to identify plasma donors (recovered Covid-19 patients) with antibodies to SARS-CoV-2, which can be used in treating Covid-19-infected patients.

The lab-based test runs on Roche’s cobas e analysers, which are available worldwide.

These fully automated systems can potentially deliver antibody test results in approximately 18 minutes with a test throughput of up to 300 tests an hour, Roche noted.