Abbott Laboratories, on Monday, secured an emergency use authorization from the Food and Drug Administration (FDA) for its new coronavirus antibody test that can detect antibodies, the company said. This is the second authorization that Abbott Laboratories has been granted by the FDA to market a Covid-19 antibody test.
The new test is similar to the one that received an emergency use authorization in mid-April. However, this is available in a newer testing platform. Abbott said that it is already ready to ship millions of test this month, which will further double in June. Drugmakers and pharmaceutical companies across the world are speeding up development of Covid-19 vaccine and antibody tests, with a definite treatment yet to be found and approved by the FDA.
New antibody test more accurate
Abbott said that the emergency approval for the new antibody test is going to help identify if a person has had Covid-19 with more accuracy. The second antibody test can indicate whether a person has had Covid—19 and was either asymptomatic or recovered. Antibody testing will help provide a greater understanding of the virus, including how long antibodies stay in the body and how much of the population has been infected, the company said.
A study to determine the clinical performance of Abbott's new lab-based serology blood test found that it had more than 99.6 per cent specificity (ability to exclude false positives) and 100 per cent sensitivity (ability to exclude false negatives) in patients tested 14 days after symptoms began. However, serologic tests are used to identify past infections with COVID-19. They cannot be used to diagnose a current infection. Abbott has also received EUAs for molecular tests that can detect current infections with COVID-19.
Abbott ready to ship millions of tests
Abbott said that it is ready to ship around 30 million tests this month and will have the capacity to ship more than 60 million tests from June. The authorization from FDA means laboratories will now be allowed the test even though it hasn't been formally approved or cleared by the FDA.
Antibody tests have been gaining prominence lately, with President Donald Trump suggesting that states use these tests as they start relaxing some social distancing measures imposed to contain the pandemic. Also, US officials are corporations are pumping in money into antibody tests with expectations that more people go for these tests to gain confidence before returning to work as states start reopening.
The FDA has also tightened rules for antibody tests. Last week, it ordered manufacturers to submit emergency use authorization forms within 10 days. The announcement comes after the FDA issued its initial antibody test policy in mid March after which it found out that a large number of commercial serology tests promoted inappropriately.