Abbott Laboratories said on Wednesday its rapid coronavirus test, which can deliver results within minutes, correctly identified positive COVID-19 cases 95% of the time, based on interim data from a study.
The US health regulator issued an emergency use authorization for the test in March, but said in May that early data suggested it could produce potentially inaccurate results, particularly by failing to detect people who have the illness.
According to the new 1,003-participant study being conducted after the Food and Drug Administration's emergency use authorization, the Abbott ID Now test was able to detect those without antibodies to the coronavirus 97.9% of the time within seven days from the onset of symptoms.
The results appear to contradict a study conducted by Cleveland Clinic in April that showed the test, which is used in the White House and elsewhere to spot COVID-19, detected the virus in around 85% of cases, lower than some other COVID-19 tests.
The latest results confirm the data submitted to the FDA in March for emergency use authorization, the medical device maker said.
Abbott said it has shipped more than 12 million ID NOW tests to all 50 states to date.