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The US Food and Drug Administration has now authorized nine coronavirus tests for emergency use.
The maker of one of those tests, Abbott, promised on Wednesday to ship 150,000 laboratory tests “immediately.”
The authorizations are somewhat of a formality. FDA guidance issued earlier this week allows companies to manufacture and ship tests before receiving permission.
Yet the authorizations still offer a stamp of approval to tests, signaling that federal regulators are satisfied with their validation data and believe their benefits outweigh any risks, such as false positives or negatives.
Four other tests were authorized by the FDA this week; Abbott’s test is the fifth, for a total of nine.
Unlike tests that give results at home or in a doctor’s office, coronavirus tests must be run on specialized equipment in clinical labs.
The Abbott system can process up to 470 tests per day, according to the company, whose test was authorized Tuesday. The Swiss firm Roche, whose test was greenlit last week, says its systems can process up to 960 results in eight hours.
Such “high-throughput” systems have the potential to dramatically increase testing capacity in the United States. But shortages of the people and tools needed to run the tests – like health care workers and cotton swabs – could still slow testing.
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