Abbott Labs’ New Coronavirus Antibody Test Granted Emergency Use Authorization By US FDA

The new novel coronavirus test that detects Covid-19 antibodies form Abbott Laboratories has been granted emergency use authorization for usage by the United States Food and Drug Administration, the company has said.

The company has announced that this month, it aims to ship at least 30 million test kits and by June, the company will increase its capacity to make and ship to about 60 million test kits.

The company said that its new test is able to accurately indicate whether a person has had Covid-19, the disease caused by the novel coronavirus, as well as indicate whether the patient was asymptomatic or had completely recovered.

“Having more options of highly reliable tests across our platforms will help healthcare workers and health officials as they conduct broad scale testing for Covid-19,” Abbott CEO Robert Ford said in a statement.

This emergency authorization means that this new test can be used by laboratories for detection of Covid-19 infections even though the tests have not yet been fully and formally approved or cleared by the FDA.

Millions of dollars are being invested into antibody testing by US officials and corporations across America and the investments are being made in the hope that any success will provide people the confidence to return to work and reopen parts of the economy.

As the various states of the US start to relax some of the strict social distancing norms that were implemented earlier to prevent the spread of the virus and try to open up parts of their economies, the US President Donald Trump has advised the states to make use the tests to help in the reopening. According to data compiled by Johns Hopkins University, the novel coronavirus pandemic has so far infected more than 1.3 million people across the United States.

Rules for coronavirus antibody tests were tightened by the FDA last week and had ordered the manufacturers to submit emergency use authorization forms within 10 days.

The FDA has become aware of “a concerning number” of commercial serology tests tat are being inappropriately promoted, including those for diagnostic use, or those were performing poorly, ever since the initial antibody test policy was announced in mid-March by the FDA, the US agency said.

This the fourth test for Cobid-19 from Abbott that has been given emergency use authorization with the FDA. three coronavirus tests in the United States had already been launched by Abbott already which included a rapid test that produces results in as little as five . it also included its newly released test that shows if a person has antibodies against the virus.

In partnership with CVS Health, Abbott is working to get its tests “outside of the hospital” and into setting such as urgent-care clinics and nursing homes, the company had announced last month.

More tests while taking up less space can be provided by its new test, Abbott said. It added that this wan important feature for labs that process tens of thousands of patient samples but are plagued with shortage of space.

(Adapted from CNBC.com)

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