FDA approves coronavirus first in-house test
- Published | 29 April 2020
On 21 April 2020, the Food and Drug Administration said it had given
emergency approval for the coronavirus' first in-home test, a nasal swab kit
that LabCorp would market. The agency said LabCorp had submitted data showing
that the home test is as secure and reliable as a set of samples in a doctor's
office, hospital or other testing site.
move, there is now a simple and secure way to obtain patient samples from the
comfort and safety of their home," FDA commissioner Dr Stephen M. Hahn
said in a statement. Patients must swab their own nose using a company-sent
test kit and mail it back to the client in an insulated package. The Pixel by
LabCorp COVID-19 test will be available in most states, with the approval of a
doctor, the agency said.
LabCorp said it will
first make the tests available to health care personnel and emergency responders
who may have been exposed to COVID-19 or are symptomatic, and make the
self-collection kits available for use in most states, according to the
department, with a doctor's order. LabCorp said that it would first make the
tests available to health care workers and emergency workers who may have been
exposed to COVID-19 or are symptomatic, and that it will make the
self-collection kits accessible to customers 'in the coming weeks.' The company
also noted that because the tests are carried out by customers in their own
homes, the demand for masks and other supplies will be reduced.
The LabCorp said the
test cost around $119. Consumers would have to pay for the test out of pocket,
a spokesperson for the company said, and ask their insurer for a refund. The
Trump administration has consistently said that coronavirus diagnostic tests
should be protected in such a way that customers will not have to foot the
bill. Around a time when governors around the country complain that their
states are facing a shortage of samples, and companies such as CVS and Walmart
are opening up drive-through test centers in parking lots, the introduction of
kits that allow people to obtain their own nasal specimens around home has the
potential to open samples to a wider audience.
Medical experts said
home-swabbing tests would improve customer convenience — and reduce people's
need to go to medical offices where they could unwittingly expose health care
providers and other patients to the infection.
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