Roche’s coronavirus antibody check is US-approved for emergency use

A health care worker conducts laboratory tests.

Sergei Karpukhin | TASS | Getty Images

Roche received EUA approval from the US Food and Drug Administration for a new test to measure coronavirus antibodies in the blood.

The Swiss diagnostics and pharmaceutical company said on Wednesday that the test is called “Elecsys Anti-SARS-CoV-2 S”. specifically detects antibodies against the virus’ spike protein in blood samples.

Roche said its antibody test targets “antibodies directed against the region of the new coronavirus known as the spike protein, specifically the area that allows the virus to bind to a host cell receptor necessary to enter.” of the virus in the virus is required. ” Host cell. “

It appeared to be positioning its tests to measure people’s antibody response to coronavirus vaccines, which may soon be widely available, and it found that “many current vaccine candidates target an antibody response to the coronavirus spike protein Tests that quantify antibodies to this spike protein could be used to measure the level of this response and track this measurement over time. “

The test provides a numerical result that describes the concentration of antibodies, as well as a qualitative result, said Roche when its CEO welcomed the test as a way of measuring future “vaccine-induced immune responses”.

“Since the beginning of this pandemic, we have focused on providing effective diagnostic test solutions for the fight against Covid-19,” said Thomas Schinecker, CEO of Roche Diagnostics, in a press release.

“Antibody tests like this one play a vital role in measuring a person’s vaccine-induced immune response,” he added.

Vaccination optimism

The Roche announcement comes amid optimism that there could be a mass launch of coronavirus vaccines soon.

Pfizer and BioNTech, Moderna and AstraZeneca have all developed vaccine candidates that are considered highly effective in clinical trials and are all now awaiting emergency approval from health authorities. The UK became the first country in the world to approve Pfizer and BioNTech’s vaccine for use on Wednesday.

The EUA issued by the FDA for the Roche antibody test follows a similar approval in mid-September in Europe or specifically in markets that accept the “CE mark”. The CE mark indicates that the products sold comply with European health, safety and environmental protection standards.

According to Roche, clinical laboratories can run their antibody tests on their own analysis units and get results in around 18 minutes with a test throughput of up to 300 tests per hour, depending on the analyzer.

In addition, Roche said that “the test can help control the distribution of plasma donations from recovered Covid-19 patients to current patients by identifying donors who have antibodies to the SARS-CoV-2 virus.”

Convalescence plasma therapy is an examination procedure in which the plasma is separated and removed from a patient’s blood. This plasma is then replaced with plasma from a donor to give the sick patient antibodies to fight the virus.

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