cloudy.png
Friday September 17th, 2021 6:57PM

Over-the-counter home test for COVID-19 gets US green light

By The Associated Press
Related Articles
  Contact Editor

WASHINGTON (AP) — The first home test for COVID-19 that doesn't require a prescription will soon be on U.S. store shelves.

U.S. regulators Tuesday authorized the rapid coronavirus test, which can be done entirely at home. The announcement by the Food and Drug Administration represents another important — though incremental — step in efforts to expand testing options.

Regulators granted emergency use for a similar home test last month, but that one needs a doctor’s prescription.

The agency's action Tuesday allows sales in places like drugstores "where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen Hahn, in a statement.

Initial supplies of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.

A company spokesperson said the test will be priced around $30 and be available at pharmacies and for purchase online.

The kit includes a nasal swab, a chemical solution and a testing strip. The test connects digitally to a smart phone app that displays the results and then helps interpret them. Users can also connect with a health professional via the app.

For months, health experts have stressed the need for fast, widespread home testing so that people can screen themselves and avoid contact with others if they have an infection. But the vast majority of tests still require a nasal swab performed by a health worker that must be processed at high-tech laboratories. That typically means waiting days for the results. About 25 tests allow people to collect their own sample at home— a nasal swab or saliva — but then that's shipped to a lab.

Ellume’s test looks for viral proteins shed by COVID-19, which is different from the gold standard tests that look for the genetic material of the virus.

Like other tests that scan for proteins, FDA officials noted that Ellume’s test can deliver a small percentage of false positive and false negative results. People who get a negative result but have coronavirus symptoms should follow up with a health professional, the agency said.

Currently the U.S. is testing nearly 2 million people daily. Most health experts agree the country needs to be testing many times more and researchers at Harvard have pushed for cheap, paper home tests.

Still, Dr. Michael Mina of Harvard called the new test “a great addition," to existing options, though he cautioned that its price could limit access.

“This is a milestone, with reservations,” Mina said in an email. “I just hope it doesn’t drive more of a wedge between haves and have nots."

For people with insurance, federal law requires that plans cover the cost of COVID-19 testing.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

  • Associated Categories: U.S. News, Associated Press (AP), AP National News, AP Online National News, Top U.S. News short headlines, Top General short headlines, AP Health, AP Business
© Copyright 2021 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
Over-the-counter home test for COVID-19 gets US green light
A home test for COVID-19 will soon be on U.S. store shelves
1:02PM ( 5 minutes ago )
Birth on a riverbank: Woman's ordeal shows risks at border
A Honduran woman gave birth on the banks of the Rio Grande after being pushed across the river in a tire
12:38PM ( 29 minutes ago )
The Latest: Survey: 1 in 10 residents in Spain infected
One in ten residents in Spain had been infected by the coronavirus by mid-November and almost half that contagion occurred during the summer resurgence of outbreaks
12:24PM ( 43 minutes ago )
U.S. News
Boko Haram claims abduction of students in northern Nigeria
Rebels from the Boko Haram extremist group claimed responsibility for abducting hundreds of boys from a school in Nigeria’s northern Katsina State last week
12:46PM ( 21 minutes ago )
Feds to delay seeking legal protection for monarch butterfly
The monarch butterfly will have to wait longer to receive protection under the Endangered Species Act
12:29PM ( 39 minutes ago )
WHO to sift Chinese samples, data in hunt for virus origins
A scientist taking part in the World Health Organization’s mission track down the origins of the coronavirus says they plan to sift through samples and medical data from China to help determine where the bug came from
12:28PM ( 39 minutes ago )
Associated Press (AP)
GOP leader McConnell finally acknowledges Biden won election
Senate Majority Leader Mitch McConnell has finally acknowledged that Democrat Joe Biden won the presidential election
11:45AM ( 1 hour ago )
Biden returns to Georgia as validator for Ossoff, Warnock
As Republicans try to brand Georgia's Democratic candidates as puppets who would ensure a leftist takeover of the Senate, Democrats believe they have a helpful counter to the exaggerated attacks: President-elect Joe Biden
11:44AM ( 1 hour ago )
GOP leader McConnell congratulates Biden as president-elect
Senate Majority Leader Mitch McConnell congratulated Democrat Joe Biden on Tuesday as the president-elect
10:55AM ( 2 hours ago )
AP National News
EU unveils plan to toughen rules for tech giants
Big tech companies face hefty fines in Britain and the European Union if they treat rivals unfairly or fail to protect users on their platforms, in proposed regulations unveiled Tuesday
11:38AM ( 1 hour ago )
French theater, cinema workers protest against virus closure
Thousands of people working in the theater and cinema industries have staged a street demonstration in Paris against the prolonged closure of entertainment facilities amid the coronavirus pandemic
11:19AM ( 1 hour ago )
Wall Street tries again to snap losing streak, pushes higher
Stocks on Wall Street are making another run at breaking their losing streak, and the S&P 500 is up 0.5% in morning trading on Tuesday
10:31AM ( 2 hours ago )
AP Business
Birth on a riverbank: Woman's ordeal shows risks at border
A Honduran woman gave birth on the banks of the Rio Grande after being pushed across the river in a tire
12:38PM ( 30 minutes ago )
The Latest: Survey: 1 in 10 residents in Spain infected
One in ten residents in Spain had been infected by the coronavirus by mid-November and almost half that contagion occurred during the summer resurgence of outbreaks
12:24PM ( 44 minutes ago )
FDA allows use of over-the-counter home test for COVID-19
A home test for COVID-19 will soon be on U.S. store shelves
12:11PM ( 57 minutes ago )
US vaccinations ramp up as 2nd COVID-19 shot nears
Hundreds more U.S. hospitals are gearing up to vaccinate their workers as federal health officials posted a positive review of a second COVID-19 shot
12:07PM ( 1 hour ago )
The Latest: Averages of deaths, infections surge in Arizona
Arizona on Tuesday reported more than 60 additional known deaths from the coronavirus
11:53AM ( 1 hour ago )