Suggested reading: The ‘game changer’ that wasn’t: Company falsely claimed FDA authorization for coronavirus blood test
Source: The Hill
The Food and Drug Administration issued emergency approval to a two-minute test for coronavirus, its maker, Bodysphere Inc., said Tuesday.
The move could help increase the U.S. testing capability, which has been improving but is still not where it needs to be, according to governors.
“Results are delivered on site in as fast as two minutes,” Bodysphere said in a press release. “This is a game changer as today in the United States, most COVID-19 testing results take between two to seven days.”
The company said it is positioned to “have millions of test kits on the front lines in weeks” and is working with federal agencies to distribute the tests.
FDA authorizes two-minute antibody testing kit to detect coronavirus
The Food and Drug Administration issued an emergency approval Tuesday for a serological testing kit produced by Bodysphere Inc. that can detect a positive or negative result for COVID-19 in two minutes.
Why it matters: Access to testing has improved in the U.S. thanks to commercial labs, but the average wait time for a patient’s results is four to five days — with some reports of it taking more than a week.
- These antibody tests could help people know if they are able to go back to work, as well as aid researchers in tracking the scale and death rate of the disease — key data for current and future pandemic policies.
- They’re especially useful for determining whether health care workers have some immunity and are at lower risk if they go back to work.
Yes, but: The Bodysphere two-minute test can only detect the coronavirus in people who have had the infection for several days, meaning the test can’t be used too early on when the body hasn’t produced enough antibodies.
The big picture: The FDA has been rushing to approve tests from companies that promise quicker results.
- Abbott Laboratories received emergency authorization last week to produce portable coronavirus tests, which the company indicates can detect the virus within five minutes.
Go deeper: The other coronavirus test we need
Suggested reading by Zia H Shah MD, Chief Editor of the Muslim Times
The self isolation for 70 years and older may last up to 4 months
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“We project that roughly 56 percent of our population – 25.5 million people – will be infected with the virus over an eight week period,” Governor Newsom of California wrote on 3/19/2020.