FDA approves Roche coronavirus antibody test for emergency use

Swiss pharmaceutical company Roche says it has received an emergency use authorization from the Food and Drug Administration (FDA) for its new test for coronavirus. The company joins several others such as Abbott Laboratories, Becton Dickinson, and DiaSorin in offering antibody tests for the virus.

“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” Thomas Schinecker, CEO Roche Diagnostics, said in a statement.

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Roche says that the antibody test is highly specific to SARS-CoV-2, the strain of the virus which causes COVID-19, and that it detects this strain only and not other similar coronaviruses. This should lower the rates of false positives.

A false positive is when a test shows that a patient does have the antibodies, when in fact they do not. This is potentially dangerous as people could think that they have immunity when they do not. Therefore, a test with low rates of false positives is valuable.

”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis,” said Severin Schwan, CEO Roche Group.

Testing for coronavirus is important as health experts say it is the best way to prevent the spread of the disease, and eventually to life quarantines. But it has been particularly difficult to get a coronavirus test in the U.S. compared to other countries like South Korea, due to issues with faulty tests, convoluted procedures for getting new tests approved, and a lack of labs available to test collected samples.

However, the World Health Organization (WHO) has warned that antibody tests may not be the silver bullet that they have been promoted as in some quarters. Even if somebody does have the antibodies to coronavirus in their system, that does not necessarily mean that they are immune to coronavirus. It may be possible for them to be infected again. That’s why the WHO has not supported the idea of “immunity passports” for those who test positive for antibodies.

Still, even if the tests cannot be used as a 100% guarantee of immunity, they provide important information about the spread of the disease and give doctors and other healthcare workers information on which people to isolate and when it may be safe to lift quarantine restrictions.

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