First home testing kit for COVID-19 approved by FDA
First home testing kit for COVID-19 approved by FDA,The first approval for a COVID-19 at-home test kit has been issued by the US FDA(Food and Drug Administration).
LabCorp, the research company that produces the products, says it would require first access to it for health care professionals and first responders. For this test, people who are eligible to obtain a fluid sample may swab their nose, but they will still have to apply it to a testing laboratory. Self-sampling sidesteps the need for a clinician to perform the test, minimizing their symptomatic response to patients to it. Additional personal protective equipment, which is in short supply, is also released. The trial cost $119.
People who take this exam will swirl a swab of cotton just within their nostrils. If clinicians take samples for a COVID-19 examination, they stick a swab really deep into the nose of a patient, where their nose’s back reaches the top of their mouth. According to an study performed by UnitedHealth Group and the Gates Foundation, self-administered nose swabs are just as effective as the more invasive swabbing methods. At the end of March, the FDA began to require certain types of swabs, but the agency said they still needed to be performed under a clinician’s supervision.
In the last month, a number of biotech companies have developed and attempted to sell at-home tests, saying they can manufacture them under regulations that require accredited laboratories to develop and distribute their own tests. Nevertheless, the FDA also said that any test kit that helps people to obtain their own samples at home would require more authorisation. The LabCorp study, developed by its consumer-focused research brand, Pixel, is the first authorisation to be obtained. Already the laboratory part of its study had been accepted for use, but it still relied on samples obtained by health care staff. As all other COVID-19 tests on the market , the FDA approved this test under its rules on emergency use; it has not gone through the usual approval process.
About 147,000 COVID-19 tests are conducted every day in the United States, which experts say is still well below the amount of tests needed to contain the outbreak.
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