New 5-Minute Coronavirus Tester Approved by FDA

[easysurfer]

A five-minute, point-of-care coronavirus test could be coming to hospitals next week, and experts say it could be "game-changing."The U.S. Food and Drug Administration issued Emergency Use Authorization to Illinois-based medical device maker Abbott Labs on Friday for a coronavirus test that delivers positive results in as little as five minutes and negative results in 13 minutes, the company said.
The company expects the tests to be available next week and expects to ramp up manufacturing to deliver 50,000 tests per day, according to a press release.

"I am pleased that the FDA authorized Abbott's point of care test yesterday. This is big news and will help get more of these tests out in the field rapidly," said FDA Commissioner Steve Hahn in a statement. "We know how important it is to get point of care tests out in the field quickly. These tests that can give results quickly can be a game changer in diagnosing COVID-19."

https://www.usatoday.com/story/news...ott-labs-fast-portable-covid-test/2932766001/

 

[copyright1997reloaded]

https://www.usatoday.com/story/news...ott-labs-fast-portable-covid-test/2932766001/

As an Abbott stockholder, I am pretty proud of them. They now have two testing platforms:
1) Tests done using their M2000 realtime platform: https://www.molecular.abbott/us/en/products/infectious-disease/RealTime-SARS-CoV-2-Assay (March 18 FDA approval)

2)This new 5/15 minute test (5 minutes for positives, 15 minutes for negative validation) on Abbott's "ID Now" point of presence system: https://www.abbott.com/corpnewsroom/product-and-innovation/detect-covid-19-in-as-little-as-5-minutes.html

This is one of the stocks I have in my "keep forever" collection (I've owned the stock since 2010 and have added to it a couple times).

 

[Midpack]

Boy would that be helpful. Hopefully 50K/day will make a dent in the demand, or Abbott will share with other capable existing production capacity?

 

[steelyman]

This is one of the stocks I have in my "keep forever" collection (I've owned the stock since 2010 and have added to it a couple times).

It seems like a good choice. Abbott also developed the Freestyle Libre CGM (continuous glucose monitor) system.

 

[NW-Bound]

As an Abbott stockholder, I am pretty proud of them. They now have two testing platforms:
1) Tests done using their M2000 realtime platform: https://www.molecular.abbott/us/en/products/infectious-disease/RealTime-SARS-CoV-2-Assay (March 18 FDA approval)

2)This new 5/15 minute test (5 minutes for positives, 15 minutes for negative validation) on Abbott's "ID Now" point of presence system: https://www.abbott.com/corpnewsroom...etect-covid-19-in-as-little-as-5-minutes.html

This is one of the stocks I have in my "keep forever" collection (I've owned the stock since 2010 and have added to it a couple times).

That machine ID NOW is quite compact. It is meant for doctor's offices, and not a mass-testing facility like Labcorp or Quest Diagnostics. It would be very good to provide test access to rural areas.

It is manually operated, and runs one sample at a time. Assuming operating it non-stop, a maximum of 100 tests is done each 24-hour period. I wonder how many of these machines are installed throughout the US.

 

[NW-Bound]

On another thread, I shared the news of the test available on the large automated machines built by Roche Holdings, a Swiss company.

Their machines can process 4,000 samples per day. With 110 of these machines in the US, that's more than 400K tests per day, although I think these machines are also used to run various other tests, which we cannot put all aside to do just coronavirus.

Even if all these machines are dedicated to coronavirus, it still takes 2 years to test everyone in the US.

And that is to test everyone just once. If we want to retest people who were negative but now have symptoms, then multiple tests per person will take even more resources.

 

[Ready-4-ER-at-14]

Chicago health authorities on tv have been complaining about having to send these tests to large places in California because the report back time has been large.

Maybe some of the new machines will be more local.. seems Chicago is spiking bad recently.

 

[Teacher Terry]

My sister lives in Chicago and they are turning the McCormick place into a hospital.

 

[Masquernom]

In an article on the Abbott machine, they mentioned there are already about 18,000 of the machines the cassette plugs into located in the US.

 

[Jerry1]

That machine ID NOW is quite compact. It is meant for doctor's offices, and not a mass-testing facility like Labcorp or Quest Diagnostics. It would be very good to provide test access to rural areas.

It is manually operated, and runs one sample at a time. Assuming operating it non-stop, a maximum of 100 tests is done each 24-hour period. I wonder how many of these machines are installed throughout the US.

I could see how having that in a doctor’s office could be very valuable. The last place I want to be is those long lines in my car. Plus, for the dr to know right away hopefully will get treatment advanced sooner. I’m no dr, but I think some of the bad cases could be reduced if treated sooner.

 

[NW-Bound]

In an article on the Abbott machine, they mentioned there are already about 18,000 of the machines the cassette plugs into located in the US.

Yes, I saw that number too. But how to put that into context?

There are approximately 230,187 physician practices in the United States. Not all of them are general practitioners, and I don't know how to subtract out the specialists such as podiatrists, dermatologists, etc... who would not need this machine.

But it looks like the chance of your GP having one machine is not that great.

And then, the limit of Abbott's 50,000 tests/day means there are only 3 tests available for each machine.

Your chance of getting a test is slim.

 

[Rianne]

I could see how having that in a doctor’s office could be very valuable. The last place I want to be is those long lines in my car. Plus, for the dr to know right away hopefully will get treatment advanced sooner. I’m no dr, but I think some of the bad cases could be reduced if treated sooner.

Maybe sold on Amazon, soon? Be nice to avoid Dr. office, drive through all together.

 

[Independent]

In tangentially related news "The FDA just okayed multiple 15-minute blood tests ..." https://techcrunch.com/2020/03/27/t...screen-for-coronavirus-but-there-are-caveats/

the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2

https://www.fda.gov/medical-devices...s-diagnostic-testing-sars-cov-2#offeringtests

This notice includes a list of 33 tests manufactured by 25 companies. Almost all the companies are Chinese.

The wording means they can use the test, even though the FDA hasn't reviewed their validity. So "okayed" in the headline is too strong.

See the sixth question referring to "Section IV. D. of the Policy ..."

These are blood tests. Many specify a finger-prick of blood, with results in minutes. No machinery required. Here's one example that helps me visualize the process. By overlapping patients, it seems a nurse/tech could run dozens of tests per hour.

https://www.biomedomics.com/products/infectious-disease/covid-19-rt/

This particular test is manufactured in Singapore, with a US company importing the test.

These are antibody tests. They detect antibodies whether or not you have an active infection.

 

[sengsational]

I looked for a couple of minutes, but couldn't find the sensitivity and specificity? So why have they buried those essential to know values? Immunoassays generally have a high rate of false negatives (low sensitivity). EDIT: I didn't find "clinical" in downloads.

 

[Independent]

Did you click on "clinical" in the downloads on the left?

Note, the FDA is not approving, they are "not objecting" subject to use of strong caveats.

 

[FIREd_2015]

My understanding is the Abbott ID NOW is an antigen test meaning it tests for the virus itself. What Dr. Fauci and Governor Cuomo have repeatedly said is we need to test people for the COVID-19 antibody so we know who is potentially immune and can go back to work. This will be key in getting the country open for business. Here are a couple of articles on antibody testing in the US.

A doctor in Garden Grove, California (Southern Calif) has been importing COVID-19 antibody test kits from South Korea. Here is the link to the article

https://www.ocregister.com/2020/03/...in-u-s-to-offer-coronavirus-rapid-blood-test/

Another article warns people about doing these tests:

https://www.ocregister.com/2020/03/...blood-test-could-spell-trouble-experts-say-2/

President Trump has asked South Korea for test kits. I'm assuming these are antibody test kits.

https://www.npr.org/sections/corona...y-including-coronavirus-tests-from-south-kore

 

[copyright1997reloaded]

My understanding is the Abbott ID NOW is an antigen test meaning it tests for the virus itself. What Dr. Fauci and Governor Cuomo have repeatedly said is we need to test people for the COVID-19 antibody so we know who is potentially immune and can go back to work. This will be key in getting the country open for business. Here are a couple of articles on antibody testing in the US.

A doctor in Garden Grove, California (Southern Calif) has been importing COVID-19 antibody test kits from South Korea. Here is the link to the article

https://www.ocregister.com/2020/03/...in-u-s-to-offer-coronavirus-rapid-blood-test/

Another article warns people about doing these tests:

https://www.ocregister.com/2020/03/...blood-test-could-spell-trouble-experts-say-2/

President Trump has asked South Korea for test kits. I'm assuming these are antibody test kits.

https://www.npr.org/sections/corona...y-including-coronavirus-tests-from-south-kore

I *thought* I read that a company had an antibody test ready.

Also, Abbott's CEO (both previous and new as the reigns are being turned over today) were on Cramer's Mad Money - and indicated they had a team working on Antibody tests.

 

[FIREd_2015]

I *thought* I read that a company had an antibody test ready.

Also, Abbott's CEO (both previous and new as the reigns are being turned over today) were on Cramer's Mad Money - and indicated they had a team working on Antibody tests.

"...The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization for the test which uses antibodies in blood to test for current or past infection...Results are delivered on site in as fast as two minutes...BODYSPHERE is positioned to have millions of test kits on the front lines in weeks..."

https://www.businesswire.com/news/h...uthorizes-New-Two-Minute-Serological-Test-Kit

 

[gauss]

Boy would that be helpful. Hopefully 50K/day will make a dent in the demand, or Abbott will share with other capable existing production capacity?

Between the Abbott Labs M2000 centralized tester described above, and also the point-of-car 15 minute test platform, Abbott Labs claims to have plans to manufacture 5 million test kits during the month of April.

-gauss

 

[ERD50]

My sister lives in Chicago and they are turning the McCormick place into a hospital.

Well, not exactly a "hospital", but a care center to reduce demand on established hospitals.

For those unaware, McCormick Place is a large convention center in Chicago (Auto shows, restaurant shows, etc). Since most of those have been cancelled/postponed, it's now an available space to meet this need.

This is why I keep referring to "static models" versus "dynamic models". The world changes in response to inputs. We may not have enough hospital beds, until we adapt.

The numbers still help us to see where we need to respond, but it should not be assumed that we won't respond, and the outcome will be changed.

Here's a link (behind a paywall I think, I'm a subscriber):

https://www.chicagotribune.com/coro...0200331-qhhxhvgtovedbcyn5cgqlq73zi-story.html

Gov. J.B. Pritzker announced the lakefront convention center will have 500 beds available by week’s end. The medical center, which is being called an alternate care facility, eventually will be able to hold 3,000 beds for patients, most of whom would have mild symptoms and would not require intensive care.

Another group of 500 beds should be available next week, with 1,250 more by April 20. The final 750 acute care beds will be in place by the end of next month, Pritzker said.

“Based on best practices around the world on how to manage positive cases and contain this virus, McCormick will be dedicated mostly to non-acute COVID-19 patients, people who could benefit from the care of medical professionals but are not likely to need a formal ICU,”

-ERD50

 

[RetireBy90]

Oped from WSJ this morning saying we should think about medevac of patients from areas without beds or vents to places that have room or vents not being used


https://www.wsj.com/articles/operat...se-11585695115?mod=searchresults&page=1&pos=1

Instead of moving ventilators to the patients who need them, move the patients to the ventilators.