[NFA] Dr. John Chou of Sutter Health explains how the newly approved at-home COVID-19 test gets you a result without ever leaving the house. Conway G. Gittens reports.
SALT LAKE CITY (AP) — As college students prepare to go home for the holidays, some schools are quickly ramping up COVID-19 testing to try to keep infections from spreading further as the coronavirus surges across the U.S.
Thousands of cases have been connected to campuses since some colleges reopened this fall, forcing students to quarantine in dorms and shifting classes online. Now, many students are heading home for Thanksgiving, raising the risk of the virus spreading among family, friends and other
At-home testing could transform the fight against the novel coronavirus.
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.
There are some pleas for caution on at-home tests, even among their boosters. Topol, from the Scripps Research Translational Institute, argues that we first need a large clinical trial to show that the tests are effective at stopping outbreaks. The test that does so, then, could set the standard for others like it.
Other experts say that imprecise, at-home tests are a terrible idea. Michael Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, worries that if the country is awash in tests that return too many incorrect results, people will lose confidence in testing. They might refuse to get tested, refuse to self-isolate if they test positive, or get PCR and antigen tests mixed up. After the federal government gave nursing homes some antigen rapid tests, the state of Nevada ordered the homes to stop using them once they were
(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
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
(Bloomberg) — The U.S. gave a greenlight to the first Covid-19 testing kit to be used in the home, adding a new tool to battle the pandemic as nationwide testing capabilities come under more strain.
The Food and Drug Administration issued an emergency use authorization to Lucira Health Inc.’s rapid-result All-In-One Test Kit, according to a statement from the agency on Tuesday. The kit is expected to cost around $50, the company said, and consumers will need a prescription to acquire it.
While some Covid-19 tests allow people to to mail in samples collected at home, this is the first that can be fully self-administered and provides results at home in 30 minutes or less. The clearance comes at a time when the country — which has the world’s largest number of cases, at more than 11 million — is fighting a fierce resurgence of infections.
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
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.
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.
It’s nearly impossible to fathom the number of cases and deaths from the COVID-19 virus, so we added some geographical perspective.
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.
The Phase 3 clinical trial began on July