U.S. FDA approves first rapid coronavirus test with 45 minutes detection time

[rooster59]

U.S. FDA approves first rapid coronavirus test with 45 minutes detection time

By Kanishka Singh

 

FILE PHOTO: A computer image created by Nexu Science Communication together with Trinity College in Dublin, shows a model structurally representative of a betacoronavirus which is the type of virus linked to COVID-19, better known as the coronavirus linked to the Wuhan outbreak, shared with Reuters on February 18, 2020. NEXU Science Communication/via REUTERS

 

(Reuters) - The U.S. Food and Drug Administration has approved the first rapid coronavirus diagnostic test, with a detection time of about 45 minutes, as the United States struggles to meet the demand for coronavirus testing.

 

The test's developer, California-based molecular diagnostics company Cepheid, said on Saturday it had received an emergency use authorization from the FDA for the test, which will be used primarily in hospitals and emergency rooms.

The company plans to begin shipping it to hospitals next week, it said.

 

The FDA confirmed its approval in a separate statement. It said the company intends to roll out the availability of its testing by March 30.

 

Under the current testing regime, samples must be sent to a centralized lab, where results can take days.

 

"With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them," U.S. Secretary of Health and Human Services Alex Azar said on Saturday.

 

The United States is not even close to meeting domestic demand for coronavirus testing. Many medical experts have predicted that delayed and chaotic testing will cost lives, potentially including those of doctors and nurses.

 

On Friday, Anthony Fauci, director of National Institute of Allergy and Infectious Diseases, was asked whether the United States can currently meet demand for tests.

 

"We are not there yet," Fauci said.

 

The diagnostic test for the virus that causes COVID-19 has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems globally, the company said.

 

The systems do not require users to have special training to perform testing, and are capable of running around the clock, Cepheid President Warren Kocmond said in the statement.

 

The company did not give further details or say how much the test will cost.

 

The U.S. FDA has been pushing to expand screening capacity for the virus while the World Health Organization has called for "order and discipline" in the market for health equipment needed to fight the outbreak.

 

(Reporting by Kanishka Singh in Bengaluru; Editing by Sonya Hepinstall and Daniel Wallis)

 

-- © Copyright Reuters 2020-03-22

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[bkk6060]

Of course.

Just like most modern day technologies and medical advances, the US will be at the forefront of this.

Vaccine will be next.

You are welcome.

 

Edited March 22, 2020 by bkk6060

[Tug]

Why did this take so long the trump administration knew about this in January why the epic delay?s Korea been doing it for weeks now it’s about time!!!

[stevenl]

28 minutes ago, bkk6060 said:

Of course.

Just like most modern day technologies and medical advances, the US will be at the forefront of this.

Vaccine will be next.

You are welcome.

 

The Irish developed kits that give results in 15 minutes.

 

What is this thread about?

[Eric Loh]

Countries should get together to support each other in this time of need. China sent 50,000 test kits to Europe and should do likewise with US if only Trump lift up

the phone and ask Xi. 
https://www.ft.com/content/186a9260-693a-11ea-800d-da70cff6e4d3

[Rimmer]

A conspiracy troll post has been removed

 

A post with a link to an unreliable source has been removed

[rabas]

7 hours ago, stevenl said:

The Irish developed kits that give results in 15 minutes.

 

What is this thread about?

Completely different test. The Irish test is simple old style antibody test, though useful. This test by Cepheid is based on the very latest CRISPER testing technology just released from MIT and its Broad Institute in the US. MIT is making the technology widely available. The new test just announced by Thailand is also based on the same Broad Institute CRISPER technology.

 

CRISPER is a game changer because it tests for the actual viral RNA like the much more expensive and time consuming RT-PCR technology. 

 

South Korea's success comes in part from combining CCTV and mobile surveillance with lots of RT-PCT testing. They were better prepared because they had been hit hard by SARS.

Edited March 22, 2020 by rabas

[rabas]

1 hour ago, Eric Loh said:

Countries should get together to support each other in this time of need. China sent 50,000 test kits to Europe and should do likewise with US if only Trump lift up

the phone and ask Xi. 
https://www.ft.com/content/186a9260-693a-11ea-800d-da70cff6e4d3

They may not be talking since Xi claimed Wuhan Flu was from the US. Not a good attempt at working together is it?
 

Edited March 22, 2020 by rabas

[placnx]

7 hours ago, stevenl said:

The Irish developed kits that give results in 15 minutes.

 

What is this thread about?

The Irish developed what kind of test? Antibody? Viral RNA presence?

[3 minus 2]

8 hours ago, Tug said:

Why did this take so long the trump administration knew about this in January why the epic delay?s Korea been doing it for weeks now it’s about time!!!

because the media didnt start going bat <deleted> about it.. his popularity polls would have started to decline .. that's  THE ONLY REASON trump gives a <deleted> about anything...

[TheDark]

Each of these 15 or 45 minute tests are tests which check if antibodies to the virus are present in out bodies. 

 

For these test to be positive, we first have to have the virus and we also have to have been able to create immune system response within our bodies, which then can be measured.

 

These test does not measure whether we have the virus, but do measure whether we have immune system response to the virus.

 

These test are better than not having a test at all. But it's worth to notice that these tests are showing only delayed reality as our immune system reacts only afterwards we become infected.

 

 

[Krataiboy]

Sounds about as reliable as a chocolate teapot.

[Eric Loh]

51 minutes ago, rabas said:

They may not be talking since Xi claimed Wuhan Flu was from the US. Not a good attempt at working together is it?
 

This one diversion that backfired on Trump. 

[thequietman]

9 hours ago, bkk6060 said:

You are welcome.

My apologies in advance if I have misunderstood your post, but are you a scientist and did you devise this exceptional break through in medical science that can save countless lives, OR are you an armchair TV'er whose only claim to this, is that he was shot out of a Mercan ladies beaver and got a passport for same county?

 

Just curious. Please accept  my apologies if you were in fact, heavily involved in this breakthrough. We are truly grateful to you sir. ????

[Pedrogaz]

Not been in the field for a while but PCR takes 24 hours minimum.....what is the sensitivity of this test. How many false negatives.

[TheDark]

3 minutes ago, Pedrogaz said:

Not been in the field for a while but PCR takes 24 hours minimum.....what is the sensitivity of this test. How many false negatives.

When you were in the field of healthcare? 

 

We have loads of ex-SAS member on this forum. We are about to have a lot of ex-doctors on this forum as well. 

 

When you state you credentials by saying that you have not been in the field for a while, please provide something for us to trust your words. 

[Chiphigh]

9 hours ago, Tug said:

Why did this take so long the trump administration knew about this in January why the epic delay?s Korea been doing it for weeks now it’s about time!!!

So now you want trump to bypass the fda approval process? Then you would accuse him of another thing. Perhaps the constructive way would be to look at the regulations and fix the problem, like what hasn't been done for decades. But as long as you can find another excuse to bash, go for it, well done. 

[rabas]

29 minutes ago, TheDark said:

Each of these 15 or 45 minute tests are tests which check if antibodies to the virus are present in out bodies. 

 

For these test to be positive, we first have to have the virus and we also have to have been able to create immune system response within our bodies, which then can be measured.

 

These test does not measure whether we have the virus, but do measure whether we have immune system response to the virus.

 

These test are better than not having a test at all. But it's worth to notice that these tests are showing only delayed reality as our immune system reacts only afterwards we become infected.

Why do you think this is antibody testing? CRISPR can detect the actual viral RNA like PCR but in 30-45 minutes. Rapid Detection of 2019 Novel Coronavirus SARS-CoV-2 Using a CRISPR-based DETECTR Lateral Flow Assay

 

[candide]

Great news! If It's reliable then it will be only a matter of defining a policy.

[TheDark]

47 minutes ago, rabas said:

Why do you think this is antibody testing? CRISPR can detect the actual viral RNA like PCR but in 30-45 minutes. Rapid Detection of 2019 Novel Coronavirus SARS-CoV-2 Using a CRISPR-based DETECTR Lateral Flow Assay

 

Because that's how these testing kits normally work. 

 

And no, I'm not an expert on this field, but I do tend to keep my eyes and ears open for all knowledge I can get from the professionals. 

 

What I understood, this novel coronavirus (meaning it's a new virus to us) is only the 7th coronavirus outbreak the world has ever seen.

 

That is yet another indicator, how serious issue we are dealing with right now. We don't have collective herd immunity to this virus and we don't really even understand what we are dealing with.  Because this virus is new to us. 

 

So all we can really do is to study the virus and try to slow down the spread, so that our healtcare systems wont overload. When our healtcare systems overloads, it's the elderly who will pushed away to die, simply because they have less to live.

 

Do you want our doctors and nurses to have to make such drastic decisions, who can live and who will die? I don't and that's why I wish to solve this emergency in more subtle way. 

 

In reality our doctors and nurses will have to make those decisions, like the Italian doctors did before. 

[DrTuner]

Lots of test kits popping up now. As many questions popping out about the claimed detection accuracy and speed. While it's good there is progress, the data that comes out of using these kits might have a fairly large systematic error. I hope they continue PCR on the side to detect that.

[DrTuner]

16 hours ago, bkk6060 said:

Just like most modern day technologies and medical advances, the US will be at the forefront of this.

I don't know why that would be surprising to anyone. US is home to some of the best universities and research facilities in the world. They are not twiddling their thumbs during all of this.

[rabas]

9 hours ago, DrTuner said:

I don't know why that would be surprising to anyone. US is home to some of the best universities and research facilities in the world. They are not twiddling their thumbs during all of this.

That's why the Chinese are there in droves. And also note US research is made up of people from everywhere. 

[lannarebirth]

6 minutes ago, rabas said:

That's why the Chinese are there in droves. And also note US research is made up of people from everywhere. 

 

Which is why countries everywhere are now competing with the US. The joke goes like this: “How far behind the US is China in AI research?” Answer: “12 hours.”

[Eric Loh]

14 minutes ago, rabas said:

That's why the Chinese are there in droves. And also note US research is made up of people from everywhere. 

Learn from the best and bring home the knowledge. 

[bristolboy]

6 minutes ago, lannarebirth said:

 

Which is why countries everywhere are now competing with the US. The joke goes like this: “How far behind the US is China in AI research?” Answer: “12 hours.”

In 2012, China's spending on R&D was 34% that of America’s. But, by 2016, based on ‘purchasing power parity’, the giant Asian nation’s spending was equivalent to 88% that of the US. It seems likely to surpass America soon. China's budget for basic research hit US$14.1 billion in 2016, up 18.5% over the previous year.

https://www.universityworldnews.com/post.php?story=20181207064734679

[bristolboy]

Trump’s new budget cuts all but a favored few science programs

"No one from NIH, whose $42 billion budget makes it by far the government’s largest funder of basic research, was present at the briefing to defend Trump’s proposed $3 billion, 7% cut in biomedical research. And NSF Director France Córdova, who steps down on 31 March after completing her 6-year term, promised only that her $8 billion agency would “continue to support science and science education” despite facing a proposed cut of 6.5%."

https://www.sciencemag.org/news/2020/02/trump-s-new-budget-cuts-all-favored-few-science-programs

 

 

[lannarebirth]

4 minutes ago, bristolboy said:

In 2012, China's spending on R&D was 34% that of America’s. But, by 2016, based on ‘purchasing power parity’, the giant Asian nation’s spending was equivalent to 88% that of the US. It seems likely to surpass America soon. China's budget for basic research hit US$14.1 billion in 2016, up 18.5% over the previous year.

https://www.universityworldnews.com/post.php?story=20181207064734679

Yes I know. I follow that stuff closely. Mostly it's about how to use existing technology (admittedly leading edge) for both profit and control. They're not going to be leading anything unless they beat us in quantum computing, which is a real possibilty.

[bristolboy]

2 minutes ago, lannarebirth said:

Yes I know. I follow that stuff closely. Mostly it's about how to use existing technology (admittedly leading edge) for both profit and control. They're not going to be leading anything unless they beat us in quantum computing, which is a real possibilty.

Actuallly, the Chinese are very close to catching up with the USA in basic research. Nearly there already for papers published in Nature and Science.

"Nature Index counts the number of authors by country in Science and Nature and reports that China is only a few years away from overtaking the US in authorship in these premier international journals."

https://www.universityworldnews.com/post.php?story=20181207064734679

Edited March 23, 2020 by bristolboy

[rabas]

9 minutes ago, bristolboy said:

Trump’s new budget cuts all but a favored few science programs

"No one from NIH, whose $42 billion budget makes it by far the government’s largest funder of basic research, was present at the briefing to defend Trump’s proposed $3 billion, 7% cut in biomedical research. And NSF Director France Córdova, who steps down on 31 March after completing her 6-year term, promised only that her $8 billion agency would “continue to support science and science education” despite facing a proposed cut of 6.5%."

https://www.sciencemag.org/news/2020/02/trump-s-new-budget-cuts-all-favored-few-science-programs

Maybe he feels, as I do, that America's $4 TRILLION per year big health industry should be pulling their share of the load. Of course it wasn't that big before Barack ACA Obama's reign.