Roche Obtains Emergency Use Sign From US FDA For COVID-19 Antibody Test


(Reuters) – Roche Holding AG has received emergency approval from the United States Food and Drug Administration (FDA) for an antibody test to determine if people have ever been infected with the coronavirus, said Sunday the Swiss pharmacist.

Governments, businesses, and individuals are looking for such blood tests, to help them learn more about who may have had the disease, who may have some immunity, and to possibly develop strategies to end the blockages that have hit them. world economies.

Roche previously pledged to make its antibody test available in early May and increase production by June to “double-digit millions” per month.

The Basel-based company, which also performs separate molecular tests to identify people with active COVID-19 infections, said its antibody test, Elecsys Anti-SARS-CoV-2, has a specificity rate about 99.8% and a sensitivity rate of 100%. .

These rates help determine if a patient has been exposed to COVID-19, the respiratory disease caused by the coronavirus, and if the patient has developed antibodies against it.

DiaSorin in Italy has also developed tests to identify the antibodies that develop after someone has come into contact with the virus.

Diasorin and Abbott recently obtained US emergency clearance for their tests.

Countries have various plans to use these tests to better understand COVID-19, while also identifying those who have been infected but have shown mild or no symptoms.

A false false positive result could lead to the false conclusion that someone has immunity.

During the development of its test, Roche examined the reliability of certain existing products before rejecting them, had said earlier its general manager, Severin Schwan.

Schwan said there are about 100 such tests offered, including finger prick tests that provide a quick result.

He declined to specify the competing tests he had studied, but said he was not referring to tests performed by established test companies.

Roche said his antibody test requires an intravenous blood test to determine the presence of antibodies, including immunoglobulin G (IgG), which stays longer in the human body, suggesting possible immunity .

As the demand for blood antibody tests continues to grow, a range of distributors with no experience or established medical testing skills have joined experienced companies in a U.S. but unregulated market, according to a Reuters survey.

The rush to obtain, advertise and find buyers for the test kits follows the FDA’s decision to allow any company to sell antibody tests in the country without prior review by the agency.

It comes after the agency was criticized for not acting quickly enough with diagnostic tests.

The FDA has stated that the objective of its policy is to provide laboratories and healthcare providers with rapid access to testing, but that it will adjust the approach as necessary.

Reports by Aakriti Bhalla to Bengaluru and John Miller to Zurich; Editing by Himani Sarkar

Our standards:Principles of the Thomson Reuters Trust.


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