Antibody testing to determine who has been exposed and potentially immune to the virus has been touted as one of the most important steps in re-opening the economy and enabling workers to return to work.
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The Food and Drug Administration announced Tuesday that it has authorized the first at-home coronavirus test that allows nasal swab specimens to be collected at home and sent to a laboratory for testing.
The FDA worked with LabCorp, a North Carolina-based company with one of the largest clinical laboratory networks in the world, in designing and setting standards for the kit, according to an FDA news release.
LabCorp reported revenue of more than $11.5 billion in 2019.
Antibody testing to determine who has been exposed and potentially immune to the virus has been touted as one of the most important requirements to a full scale economic reopening enabling millions of American workers to return to their jobs.
“We worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” said FDA Commissioner Dr. Stephen M. Hahn. “With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
Currently, some clinics and doctors’ offices in Palm Beach County are offering anti-body tests that have not received emergency approval by the FDA.
One West Palm Beach clinic performs tests in its back parking lot. The test costs $200 and patients are required to pay in cash or with Venmo, Zelle or PayPal.
The LabCorp kit tests only for coronavirus, preventing false positives that can occur with other tests that also reveal the presence of other viruses and pathogens, according to LabCorp.
LabCorp’’s self-collection kit contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample in an insulated package to a LabCorp lab for testing.
The kits will initially be made available to healthcare workers and first responders who may have been exposed to coronavirus or may show symptoms. LabCorp intends to make the home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks.
The cost of the kit and whether it will be covered by insurance is not known.
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