FDA authorized a COVID-19 home test, but the rollout will be limited

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At-home testing could transform the fight against the novel coronavirus.

USA TODAY

The nation’s first Food and Drug Administration authorized home coronavirus test will cost about $50 and deliver results in 30 minutes or less.

But forget about the test if you want to know whether you have COVID-19 before visiting family for Thanksgiving or Christmas.

The Lucira COVID-19 All-In-One Test Kit will be limited to patients at Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Fort Lauderdale until next spring. And even then, you must have symptoms and a health provider’s referral to get the test.

With the nation’s labs, doctors and urgent care centers routinely testing more than 1.5 million Americans each day, experts don’t expect the new test will make an immediate and meaningful difference for most Americans.

“I’m afraid in the near future, it’s not going to have a large impact,” said Dr.

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FDA approves first COVID-19 test kit for home use

(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 health regulator said.

Although a recent string of positive news from Moderna Inc and Pfizer Inc on their potential vaccines has

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The FDA announced emergency approval of the first COVID-19 self-test that can be done fully at home. It provides results in 30 minutes.



a person taking a selfie in a room: Dr. Vincent Carrao swabs a patient's nose for the coronavirus disease (COVID-19) test at Palisades Oral Surgery, in Fort Lee, New Jersey, U.S., June 15, 2020. REUTERS/Brendan McDermid


© REUTERS/Brendan McDermid
Dr. Vincent Carrao swabs a patient’s nose for the coronavirus disease (COVID-19) test at Palisades Oral Surgery, in Fort Lee, New Jersey, U.S., June 15, 2020. REUTERS/Brendan McDermid

  • The Food and Drug Administration (FDA) announced Tuesday the emergency approval of the first COVID-19 test that can be done fully at home.
  • Lucira Health’s COVID-19 nasal swab self-test provides results in 30 minutes or less, and is authorized only on prescription.
  • People over the age of 14 can take the test if their healthcare provider suspects they may have COVID-19, the FDA said. 
  • Stephen M. Hahn, FDA commissioner, 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.”
  • Visit Business Insider’s homepage for more stories.

The US Food and Drug Administration (FDA) on Tuesday approved the first at-home COVID-19 test kit for emergency

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The FDA Announced Emergency Approval of the First COVID-19 Self-Test That Can Be Done Fully at Home

It provides results in 30 minutes.

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This story originally appeared on Business Insider

The US Food and Drug Administration (FDA) on Tuesday approved the first at-home COVID-19 test kit for emergency use.

The COVID-19 All-In-One Test Kit, made by biotech company Lucira Health, is the first nasal swab test that can be fully self-administered at home, and it provides results in 30 minutes or less, according to a statement from the government agency.

Once the patient has done the nasal swab, it is then stirred into a vial and placed in a test unit. Within minutes, lights indicate whether the individual is positive, negative, or needs to repeat the test.

Related: The New Pfizer Vaccine Needs Plenty of Cold Storage, but Will There Be Enough Dry Ice?

The single-use test

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FDA Clears First Covid-19 Test Performed Fully at Home

The U.S. Food and Drug Administration has cleared the first Covid-19 test that people can take at home by themselves and get results without the help of a lab, a long-awaited step.

The single-use, disposable test from Lucira Health Inc. uses nasal swabs and can be self-administered by anyone with a doctor’s prescription ages 14 years or older. The test searches for the genetic material of the new coronavirus and can give results in up to 30 minutes, the company said.

Some Covid-19 tests have been previously authorized for at-home collection, but Lucira’s is the first that can be fully self-performed and provide results at home minutes later.

Public-health experts have been clamoring for fast, easy-to-use at-home Covid-19 testing, especially as the virus is spreading at increasing rates around the U.S. If made widely available and cost-effective, at-home testing could become a valuable tool in helping people to safely return

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

Here’s what you need to know:

Credit…Lucira Health

The Food and Drug Administration on Tuesday gave an emergency green light to the first rapid coronavirus test that can run from start to finish at home, paving a potential path for more widespread testing outside of health care settings.

The test, developed by California-based company Lucira Health, requires a prescription from a health care provider. People under the age of 14 also can’t perform the test on themselves. But with a relatively simple nasal swab, the test can return results in about half an hour, and is projected by the company to cost $50 or less, according to the product’s website. Clinicians can also run the test on their patients, including children under the age of 14, potentially delivering answers during a single visit to a care

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FDA approves first COVID-19 self-test kit fully done at home

  • The Food and Drug Administration (FDA) announced Tuesday the emergency approval of the first COVID-19 test that can be done fully at home.
  • Lucira Health’s COVID-19 nasal swab self-test provides results in 30 minutes or less, and is authorized only on prescription.
  • People over the age of 14 can take the test if their healthcare provider suspects they may have COVID-19, the FDA said. 
  • Stephen M. Hahn, FDA commissioner, 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.”
  • Visit Business Insider’s homepage for more stories.

The US Food and Drug Administration (FDA) on Tuesday approved the first at-home COVID-19 test kit for emergency use.

The COVID-19 All-In-One Test Kit, made by biotech company Lucira Health, is the first nasal swab test that can be fully self-administered at home, and it provides results in 30

Read More

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

Topline

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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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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