Abbott plans to ship nearly 30 million tests, which may indicate if someone has had Covid-19 in the past and was either asymptomatic or recovered in May and will have the capacity to ship 60 million tests in June, the company said in a statement. Press release.
“Having more highly reliable testing options on our platforms will help healthcare professionals and healthcare managers conduct large-scale testing for Covid-19,” said the CEO of Abbott, Robert Ford, in a press release.
EUA means that laboratories will be allowed to use the test even if it has not been officially approved or authorized by the FDA.
US officials and companies across America are investing money in antibody testing, hoping it will give people the confidence to return to work and reopen part of the economy. President Donald Trump has recommended that states use the tests as they begin to relax some of the strict social distancing measures imposed to fight the pandemic, which has infected more than 1.3 million people across the United States. United, according to data compiled by Johns Hopkins University.
Last week, the FDA tightened rules for coronavirus antibody tests, ordering manufacturers to submit emergency use authorization forms and data proving that the tests work within 10 days or are at risk to be deleted.
Since the FDA released its initial policy for antibody testing in mid-March, the agency has said it has seen “a disturbing number” of inappropriately promoted commercial serological tests, including for diagnostic use, or poor results.
This is the fourth test of Abbott Covid-19 to gain emergency use from the FDA. Abbott had previously launched three coronavirus tests in the United States, including a rapid test that produces results in as little as five minutes and the newly published test that shows whether a person has antibodies to the virus.
The company announced last month that it was working with CVS Health to get its tests “outside the hospital” and in places like emergency care clinics and nursing homes.
Abbott said the new test is more efficient and can provide more tests and take up less space, an important feature of the company for laboratories that process tens of thousands of patient samples but often lack space.
It can exclude false positives 99.6% of the time and exclude false negatives 100% of the time for patients tested 14 days after the onset of symptoms, the company said in a statement on Monday.
The company says it plans to submit for European CE marking approval this week.