FDA authorizes new two-minute test for coronavirus; antibody based?

square grunge red fda approved stamp

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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.

Read further

FDA authorizes two-minute antibody testing kit to detect coronavirus

Source: Axios

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

Read further

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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.


Categories: Health, The Muslim Times

3 replies

  1. March 31 (Reuters) – Becton Dickinson and Co and diagnostics company BioMedomics on Tuesday said they will launch a diagnostic test that can detect current or past exposure to the coronavirus within minutes, and can be used in doctors’ offices, as well as other settings.

    The test is the latest to join an arsenal of diagnostic tools for the coronavirus that can be used in community health settings such as doctors’ offices and urgent care clinics.

    “This is a simple blood test that can be done at the point of care without the need to involve a large laboratory,” David Hickey, president of Becton Dickinson’s diagnostics division, told Reuters in a phone interview.


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