The Food and Drug Administration (FDA) issued an emergency use authorization for an antibody coronavirus test developed by Roche Holding AG, the Swiss healthcare company said in a statement Sunday.
The tests are used to determine whether a person has been infected with the novel coronavirus and developed antibodies against it. State and federal officials have touted the tests as a way to help guide decisions about how to safely reopen parts of the U.S.
Roche Holding AG said that its antibody test, Elecsys Anti-SARS-CoV-2, had a 99.8 percent specificity rate and a sensitivity rate of 100 percent based on a sampling of 5,272 people.
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The company said that it would begin ramping up production of the tests to the "high double-digit millions per month" to serve countries accepting them. The firm has already started shipping the tests to some laboratories.
“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” Roche Group CEO Severin Schwan said in a statement.
”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.”
Multiple companies, including US-based Abbott Laboratories, Becton Dickinson and Co, and Italy’s DiaSorin, have reportedly received emergency approval from the FDA for their antibody tests.
The rush to develop the tests, however, has produced fears about inaccurate results. The House Oversight and Reform Committee recently released a report that showed the FDA allowed numerous antibody tests on the market without review. The committee said it resulted in hundreds of flawed tests that are still available on the market, which could lead to inaccurate conclusions about whether someone has immunity to COVID-19.
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Rep. Raja Krishnamoorthi
Subramanian (Raja) Raja KrishnamoorthiAlarm bells ring over controversial COVID testing FDA can boost the coronavirus battle by pausing the sale of e-cigarettes Five things to know about where the US stands on COVID-19 tests MORE (D-Ill.), chairman of the House Oversight and Reform Subcommittee on Economic and Consumer Policy, told The Hill last week that he wants the agency to clear the market of any unauthorized test.
In its news release, Roche said that its sampling showed no cross-reactivity to the four human coronaviruses causing a common cold, reducing the chance of false positives. The company previously said that its antibody test requires an intravenous blood draw to determine the presence of antibodies, Reuters reported.
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