BASEL: Roche Holding received approval for emergency use from the US Food and Drug Administration (FDA) for antibody tests to help determine whether people have been infected with the corona virus, Swiss drug makers said Sunday (May 3).
Governments, businesses and individuals are looking for blood tests, to help them learn more about who might suffer from this disease, who might have immunity and potentially develop strategies to end the lockdown that has destroyed the global economy.
Roche had previously promised to make antibody tests available in early May and to increase production in June to “millions of double digits high” per month.
The Basel-based company, which also conducts separate molecular tests to identify people with active COVID-19 infection, said the antibody test, Elecsys Anti-SARS-CoV-2, had a specificity level of around 99.8 percent and a sensitivity level of 100. percent
These figures help determine whether the patient has been exposed to COVID-19, a respiratory disease caused by a coronavirus, and if the patient has developed antibodies to fight it.
Other companies including the US-based Abbott Laboratory, Becton Dickinson and Co., DiaSorin Italy have also developed tests to identify antibodies that develop after a person makes contact with the virus.
Diasorin and Abbott recently obtained US emergency authorizations for their tests.
Countries have various plans to use these tests to better understand COVID-19, while also identifying those infected but showing only mild symptoms, or none at all.
False positive false results can lead to the wrong conclusion that a person has immunity.
In developing its tests, Roche examined several products available for reliability before rejecting them, its chief executive, Severin Schwan, had previously said.
Schwan said there were around 100 tests offered, including finger-prick tests which offered fast results.
It refused to determine the rival tests that had been studied, but said it did not refer to tests from established testing companies.
Roche said his antibody tests require intravenous blood sampling to determine the presence of antibodies including immunoglobulin G (IgG), which remains longer in the human body, indicating the possibility of immunity.
When demand increased for blood antibody testing, a number of distributors without established background or competence in medical testing had joined with experienced companies in an unregulated market in the United States, according to a Reuters investigation.
The rush to get, advertise, and find buyers for test kits follows the FDA’s decision to allow any company to sell antibody tests in the country without prior review by the agency.
This happened after the agency faced criticism that it was not acting fast enough with diagnostic tests.
The FDA said the aim of its policy was to give laboratories and health care providers early access to tests, but that it would adjust the approach as needed.
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