Roche receives FDA emergency use approval for its COVID-19 antibody test

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Swiss drug maker Roche has received emergency use approval from the US Food and Drug Administration (FDA) for an antibody test to help determine if people have ever been infected with the coronavirus, reports The Guardian.

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 to potentially craft strategies to end lockdowns that have battered global economies.

Roche had previously pledged to make its antibody test available by early May and to boost production by June to “high double-digit millions” per month. The Basel-based company, which also makes 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 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.

The report says other companies, including US-based Abbott Laboratories, Becton Dickinson and Co, and Italy’s DiaSorin have also developed tests to identify antibodies that develop after somebody has come into contact with the virus. DiaSorin and Abbott recently received US emergency authorisation for their tests.

Countries have various plans to use such tests to better understand COVID-19, while also identifying those who were infected but showed only mild symptoms, or none at all. An erroneous false-positive result could lead to the mistaken conclusion that someone has immunity.

As demand escalates for blood antibody tests, an array of distributors with no background or established competency in medical testing have joined experienced companies in an all-but-unregulated marketplace in the US, according to a Reuters investigation.

The report says the rush to obtain, 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 comes after the agency faced criticism that it did not act quickly enough with diagnostic tests. FDA has said the aim of its policy is to provide laboratories and healthcare providers early access to the tests, but that it will adjust the approach as needed.

Full report in The Guardian

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