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Swiss drug maker Roche Holding AG says it has received emergency use approval from the United States Food and Drug Administration (FDA) for an antibody test to help determine if people have ever been infected with the coronavirus.
Governments, businesses, and individuals are seeking such blood tests to help them learn more about who may have had the disease, who may have some immunity, and potentially devise strategies to end the blockages that have plagued world economies.
Roche had previously made a commitment to make its antibody test available in early May and to increase production in June to “double-digit high million” per month.
The Basel-based company, which also conducts separate molecular tests to identify people with active Covid-19 infections, said its antibody test, Elecsys Anti-SARS-CoV-2, has a specificity rate of 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.
Other companies, including US-based Abbott Laboratories. The USA, Becton Dickinson and Co, and DiaSorin of Italy have also developed tests to identify antibodies that develop after someone has come in contact with the virus.
DiaSorin and Abbott recently received emergency clearance from the United States for their tests.
Countries have several plans to use such tests to better understand Covid-19, while identifying people who are infected but have only shown mild or no symptoms.
An erroneous false positive result could lead to the erroneous conclusion that someone has immunity.
In developing its test, Roche tested the reliability of some existing products before rejecting them, its chief executive Severin Schwan previously said.
Schwan said about 100 such tests are offered, including fingerstick tests that offer a quick result.
He declined to specify what rival tests he had studied, but said he was not referring to tests by established test companies.
Roche has said that its antibody test requires an intravenous blood draw 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 increases, a number of distributors with no history or established competence in medical testing have joined with experienced companies in an almost unregulated market in the US. USA, According to a Reuters investigation.
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 domestically without prior agency review.
This occurs after the agency faced criticism that it failed to act quickly enough with diagnostic tests.
The FDA has said that the goal of its policy is to provide laboratories and healthcare providers early access to testing, but that it will adjust the approach as necessary.
