The United States Food and Drug Administration (FDA) has approved the country’s first home-based COVID-19 testing kit, under emergency use authorization (EUA).
The approval means, people, aged a minimum 14-years-old and above, in the US will now be able to purchase self-testing kits and get themselves tested for the virus.
However, as of now, the EUA allows the testing only under prescription by a health practitioner. The federal public health watchdog also authorized the use of the device in point-of-care settings like use in emergency rooms, doctor’s chambers, and care homes.
In such cases, the tests must be conducted by a healthcare practitioner if the patient is less than aged 14-years-old, the regulator said.
Lucira Health’s COVID-19 All-In-One Test Kit was given the EUA that can produce rapid results for a single-use.
Users will need to self-extract samples using a nasal swab and install the same in the home-based COVID-19 testing kit to confirm the presence of the SARS-CoV-2 that causes COVID-19.
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The results will be available within 30-minutes or so, and if positive the person must self-isolate and quarantine.
“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” the FDA Commissioner Stephen M. Hahn, M.D. said in a statement.
FDA in recent times has come under the pressure of the Trump administration to fast-track the development of a COVID-19 vaccine under the eponymous Operation Wrap Speed that seeks to land an approved vaccine in record-time.
But Trump’s ambitious efforts have clashed with many health experts and State governors who have opposed such a move, citing compromised efficacy of the vaccine.
Health experts also raised concerns of a potential to intermingle politics in public health after the FDA apparently took some steps that reduced the time taken and efficacy needed for an experimental vaccine to get approval for Emergency Use Authorization.
But in a swift move, the agency reportedly overturned the mandate and instead went close to announcing raise in the bar for EUA for experimental COVID-19 vaccines.
The US has, by far, the largest number of COVID-19 cases in the world, more than any other nation. Some 11.4 million people have been infected so-far and some 248k people have died.
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Testing for the presence of SARS-CoV-2 is an imperative step to keep the virus under check. People who test positive are ordered to self-quarantine and isolate.
COVID-19 testing in the US has been the key to its mammoth infection-count. More testing is equal to more infections. The US has tested more people than any other nation at 168 million tests done so-far, until November 16th, as per Statista report.
The world has gotten into historically chaotic situation thanks to the virus. many healthcare sectors around the world ar eon the cusp of breakdown from surges in new infections, as the pandemic seems nowhere near to end.
The extravagant demand for testing as an imperative tool to stem the spread of the virus has put enormous strain on production capacity.
“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” M.D., J.D., director of FDA’s Center for Devices and Radiological Health, Jeff Shuren said in a statement.