PerkinElmer's serological test is the first of its kind to receive emergency use authorization by the FDA in the fight against the coronavirus pandemic.
A Massachusetts-based company announced Tuesday the Food and Drug Administration granted an Emergency Use Authorization for its serological test, which has been shown to identify COVID-19 antibodies in the blood.
"These tests can determine who had previously been infected with COVID-19 and may have developed immunity," the release said. It is not yet known how long the antibodies that have interacted with the virus last in the bloodstream, though PerkinElmer said its test can identify responding antibodies with near-perfect accuracy up to three weeks after the virus' symptoms appear in patients., data from China indicates four in five COVID-19 cases may be asymptomatic.
A lab technician begins semi-automated testing for COVID-19 at Northwell Health Labs on March 11, 2020 in Lake Success, New York. The FDA said Monday approved laboratories can begin using a new serological test authorized for emergency use immediately in the fight against the coronavirus pandemic.In a letter to PerkinElmer dated Monday, the FDA's chief scientist wrote that data submitted by the company met the agency's requirements to authorize emergency use.
According to PerkinElmer, the company is able to produce millions of serological tests each month and is prepared to increase production as demand requires.
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