FDA Authorizes At-Home Covid-19 Test That Gives Results In 30 Minutes

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The U.S. Food and Drug Administration (FDA) on Tuesday issued an emergency use authorization to a Covid-19 self-test that can be used at home and provide results within 30 minutes, marking the FDA’s first such approval in a move that could help expand access to testing in the country.

Key Facts

The single-use testing kit, made by Lucira Health, has been authorized for home use and requires self-collected nasal swab samples in individuals who are 14 or older, the FDA announced in a news release.

The test can be used on children under the age of 14 only when the sample is collected by a healthcare provider in point-of-care settings like hospitals, doctor’s offices and urgent care centers, among other places.

Currently, the test will only be available with a prescription.

The

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Pfizer and BioNTech plan to submit a request “within days” to the Food and Drug Administration for emergency-use approval of a vaccine they say has shown to be 95% effective in mass testing.

“Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages,” said Ugur Sahin, M.D., CEO of BioNTech. “We believe we have achieved this.”

The companies said they expect to produce up to 50 million vaccine doses globally by year’s end and up to 1.3 billion doses by the end of 2021. Experts say frontline healthcare workers are expected to be first in line for inoculation.

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F.D.A. Authorizes First At-Home Coronavirus Test

Dr. Garner added that the news should be taken with a note of caution. In recent months, several experts have called for more widespread at-home testing as a way to help curb the virus’s spread. But others have raised concerns about the practicality of a strategy that would most likely rely on tests that sacrifice a degree of accuracy for convenience and a more affordable price tag.

According to the product’s instructions, Lucira’s LAMP test was able to accurately detect 94.1 percent of the infections found by a well-established P.C.R.-based test. It also correctly identified 98 percent of the healthy, uninfected people. The study, which was conducted by the company, was small, and included only people who had symptoms of Covid-19, the disease caused by the coronavirus. The packaging for the test notes that it “has not been evaluated” in asymptomatic people.

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FDA approves emergency use for first at-home Covid-19 test kit

Covid-19 nasal swab test administered on patient.

Lisa Maree Williams | Getty Images News | Getty Images

The U.S. Food and Drug Administration (FDA) has approved emergency use for the first Covid-19 test that can be conducted entirely at home.

The agency cleared the single-use test, which provides results within 30 minutes, for use by anyone aged 14 and over if their health-care provider suspects they may have Covid-19.

Produced by a privately held, California-based biotech company, Lucira Health, the kit is also eligible for use in hospitals, though patients under 14 must have their sample collected by a health-care provider.

The FDA did not reveal the price of the test. The company’s website says the test is “intended to cost less than $50.”

“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,” FDA Commissioner

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FDA approves first coronavirus test that delivers rapid results at home

The Food and Drug Administration has authorized the first rapid coronavirus test that can be taken at home and deliver results within minutes, potentially allowing people to skip long lines at testing sites as infections continue to surge nationwide.



a large building: FDA officials announced Tuesday that they had granted emergency approval to the first rapid coronavirus test that can be performed entirely at home.


© Jacquelyn Martin/AP
FDA officials announced Tuesday that they had granted emergency approval to the first rapid coronavirus test that can be performed entirely at home.

The single-use test kit from Lucira Health, Inc. relies on nucleic acid amplification technology, which is considered more accurate than antigen tests. It will cost less than $50, according to the company’s website.

Here are some significant developments:

  • Sen. Charles E. Grassley (R-Iowa), who is 87 and third in line of succession to the presidency, revealed Tuesday that he has contracted the coronavirus.
  • President Trump said Tuesday that he had “reversed the ridiculous decision” to cancel a large annual event at Arlington National Cemetery over
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U.S. FDA approves first COVID-19 test kit for home use

The word “COVID-19” is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration

(Reuters) – The U.S. Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes.

The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their health care provider, the FDA said.

“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,” FDA Commissioner Stephen Hahn said.

The kit can also be used at hospitals and point-of-care settings but samples should be collected by a healthcare provider if the individuals who are tested are younger than 14 years, the

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“We need some fundamental public health measures that everyone should be adhering to, not a disjointed, ‘one state says one thing, the other state says another thing,’” Dr. Anthony Fauci said at a conference sponsored by The New York Times.

The Trump administration, however, has left the issue to states while encouraging them to keep businesses and schools open. Facing spiraling coronavirus numbers and with a contentious Election Day now in the rearview mirror, Republican governors have begun grudgingly lining up behind their Democratic colleagues in tightening restrictions aimed at taming the pandemic.



a person standing in front of a door: A runner passes by a window displaying portraits of people wearing face masks to help prevent the spread of the coronavirus on Monday in Lewiston, Maine.


© Robert F. Bukaty, AP
A runner passes

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FDA Approves First At-Home Coronavirus Test : Coronavirus Updates : NPR

The federal government has approved the first at-home coronavirus test. Pictured is a more-typical testing site in Salt Lake City on Tuesday. The at-home tests could provide faster results.

Rick Bowmer/AP


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Rick Bowmer/AP

The federal government has approved the first at-home coronavirus test. Pictured is a more-typical testing site in Salt Lake City on Tuesday. The at-home tests could provide faster results.

Rick Bowmer/AP

Updated at 11:45 a.m. ET

The first COVID-19 diagnostic at-home self-test that provides rapid results has been approved by the U.S. Food and Drug Administration, the agency announced Tuesday.

The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test.

“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,” FDA Commissioner Stephen Hahn said in a statement.

Hahn added: “This new testing option is an important diagnostic

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As U.S. states become the first line of defense against the pandemic, disunity between the governors of Minnesota and South Dakota offered a hint that coordinated action may be a challenge. A trade group representing diagnostic laboratories said there’s a risk of longer wait times for Covid-19 test results.

While cases may be steadying or easing in some European virus hot spots, hospitalizations rose to a record in France and the U.K. reported the most infections yet.

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