WHAT YOU NEED TO KNOW:
- The FDA granted the emergency use of a new Abbott ID NOW COVID-19 test, which can give positive test results for the coronavirus in five minutes and negative results in 13 minutes, Abbott Laboratories said Friday.
- The FDA’s authorization letter and Abbott stated that the new test is similar to the technology used in rapid flu tests.
- The medical lab company aims to speed up production to provide 50,000 tests to the U.S. health care system beginning next week.
The U.S. Food and Drug Administration has approved a new rapid coronavirus test for emergency use. It reportedly could deliver results in less than 15 minutes.
On Friday, Abbott Laboratories, the American medical devices and health care company that developed the test, said it can deliver “results in as little as five minutes and negative results in 13 minutes.”
FDA also approved other tests which are able to give results within hours or days.
Based on the scientific evidence presented, the federal agency told Abbott it approved the coronavirus test after determining that “it is reasonable to believe that your product may be effective in diagnosing COVID-19.”
Additionally, the FDA said that the “known and potential benefits” of the test outweigh potential risks, such as false positives or negatives.
The FDA’s authorization letter and Abbott stated that the new test is similar to the technology used in rapid flu tests.
The agency added it has issued at least 19 other emergency use authorizations for diagnostic tests to detect the novel coronavirus, and that “it is working with more than 220 test developers who are expected to submit emergency-use authorization requests soon.”
According to the FDZ, there are over 110 laboratories that are creating COVID-19 tests under FDA policies and guidelines.
Abbott aimed to speed up production to provide 50,000 tests to the U.S. health care system beginning next week.
“Testing remains a crucial step in controlling the novel COVID-19 pandemic,” Abbott said in a statement. “Continuing to supply healthcare providers with new technologies to help curb the spread of infection is a top priority for public health officials and healthcare providers.”