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Apr 20, 2020 13:12:24   #
TriX Loc: Raleigh, NC
 
SalvageDiver wrote:
I'm sorry but you need to reread your reference. There are 4 companies that have been issued EUA for their serological tests. Cellex, Chembio Diagnostics, Ortho Clinical, and Mt Sinai Labs have been issued EUA for their kits, but accuracy is still not great.

The 'gotcha' is that FDA authorization isn't required for a company to market their device as long as they aren't used to diagnose or treat a disease. However, an FDA authorization, at least, gives the labs some assurance that the test/validation methods are reasonable.

Now, the Santa Clara study didn't use any of these devices which makes the results of the study questionable at best.
I'm sorry but you need to reread your reference. ... (show quote)


Maybe I haven’t been clear about my point, which was that there are no FDA “Approved” tests - there are 4 tests that are being evaluated on an EUA basis. We do not have enough data yet about their (or other test’s) accuracy to either approve them or trust their results 100%, and the result of testing, because of the potential errors and limited availability, makes the current numbers subject to error, which I think was your point as well unless I am misreading your posts. I agree that tests from well known companies like Abbot Labs and Bectin Dickerson are likely to be well done.

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Apr 20, 2020 14:15:51   #
scooter1 Loc: Yacolt, Wa.
 
scallihan wrote:
When the liberal press report the wrongdoings of only Republican politicians but ignore the same activities by Democrat politicians, I would not say they are reporting fairly, balanced, or unbiased news. Senators selling off stocks in February is a case in point. The liberal press reported loudly about a couple of Republicans selling off but ignored the Democrats who did the same.



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Apr 20, 2020 14:29:49   #
SalvageDiver Loc: Huntington Beach CA
 
TriX wrote:
Maybe I haven’t been clear about my point, which was that there are no FDA “Approved” tests - there are 4 tests that are being evaluated on an EUA basis. We do not have enough data yet about their (or other test’s) accuracy to either approve them or trust their results 100%, and the result of testing, because of the potential errors and limited availability, makes the current numbers subject to error, which I think was your point as well unless I am misreading your posts. I agree that tests from well known companies like Abbot Labs and Bectin Dickerson are likely to be well done.
Maybe I haven’t been clear about my point, which w... (show quote)


We may be saying the same thing, but differently. The FDA has evaluated more than 4 companies, but only 4 companies have currently received Authorization for emergency use from the FDA under the EUA guidelines. BodySphere is another company that submitted for FDA authorization but was not given authorization for emergency use.

Here is an example, the Cellex authorization letter.

https://www.fda.gov/media/136622/download

and the Cellex IFU

https://www.fda.gov/media/136625/download

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Apr 20, 2020 14:59:45   #
scallihan Loc: Tigard, OR
 
SalvageDiver wrote:
Fully agree, but if used appropriately the tests can give some insight into the infiltration of the disease into a population. The Santa Clara Study is an example of what could be a good study with the Cellex test kits and larger sample sizes, but not using their current test devices.

I am anxious to get the antibody test but I'm watching for a more reliable test, understanding that no POC is going to be 100% reliable. I'm watching for Abbott and BD to release their tests. They will probably be as good as it gets. The obvious way to improve the accuracy of the test is to do multiple sampling/testing. I'll probably do that anyway no matter whose test I use.
Fully agree, but if used i appropriately /i the ... (show quote)


The town of Corvallis, OR is trying to conduct city wide testing. Techs go out into neighborhoods and hand off tests outside and wait for respondent to bring test back to them. Voluntary, but the town seems to be on board with it.

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Apr 20, 2020 16:42:21   #
TriX Loc: Raleigh, NC
 
SalvageDiver wrote:
We may be saying the same thing, but differently. The FDA has evaluated more than 4 companies, but only 4 companies have currently received Authorization for emergency use from the FDA under the EUA guidelines. BodySphere is another company that submitted for FDA authorization but was not given authorization for emergency use.

Here is an example, the Cellex authorization letter.

https://www.fda.gov/media/136622/download

and the Cellex IFU

https://www.fda.gov/media/136625/download
We may be saying the same thing, but differently. ... (show quote)


We are in agreement.

Cheers

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Apr 20, 2020 21:08:00   #
d2b2 Loc: Catonsville, Maryland, USA
 
scooter1 wrote:
Not sure where you got your info but from everything I've researched this is not correct. Trump is not the problem. Pelosi and her minions requiring the unrelated items, Kennedy arts etc., to be included before passing. Now she is holding up additional small business loan money for more items unrelated to the virus to be included. Do you suppose her cut of the $25 mil for the arts center etc. is the reason she became a millionaire while "working for the people". Just adding 2 and 2.


Trump backed the Kennedy Center scenario. That has absolutely nothing to do with the testing issue. Please listen to Trump himself, not CNN or FOX or MSNBC.

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Apr 20, 2020 21:15:19   #
d2b2 Loc: Catonsville, Maryland, USA
 
JohnSwanda wrote:
People with virus-like symptoms serious enough to be hospitalized and die certainly have been tested.


No, they have not. I am working with hospitals and as of last week, they were "assuming" a fair percentage of COVID among patients showing symptoms, because they did not have sufficient tests to go around. The State of Maryland today ordered 500k tests from S. Korea because of a lack of available tests being available from routine even Federal sources. Trump told the states to fend for themselves in getting their own ventilators. The state of Colorado ordered 500 of them, and FEMA confiscated the shipment, stating it MAY need to have them in reserve. FEMA eventually gave Colorado 100 of them. The whole system is a cluster fu-$!

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Apr 21, 2020 11:16:09   #
Madchemist Loc: Nesbit, MS
 
tfgone wrote:
I see headline news every day of the Covid 19 statistics.
Where are the stats on Flu and common cold deaths or are they just lumping all the stats together under the Covid deaths etc to be sorted out at a later date when they have all the Post Mortem stats.
Just asking


You can go to the CDC and the WHO to get those stats.

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Apr 21, 2020 16:44:23   #
scooter1 Loc: Yacolt, Wa.
 
d2b2 wrote:
Trump backed the Kennedy Center scenario. That has absolutely nothing to do with the testing issue. Please listen to Trump himself, not CNN or FOX or MSNBC.


I don't listen to cnn or msnbc, and very seldom fox. I believe the extras Pelosi and Schumer demanded the president had to accept to get the ball rolling. There were other things that they demanded that made no sense for the stimulus either. Cost of doing business in the political arena.

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Apr 21, 2020 16:50:53   #
Longshadow Loc: Audubon, PA, United States
 
scooter1 wrote:
I don't listen to cnn or msnbc, and very seldom fox. I believe the extras Pelosi and Schumer demanded the president had to accept to get the ball rolling. There were other things that they demanded that made no sense for the stimulus either. Cost of doing business in the political arena.

Unfortunately.
If he would have bickered, it would have just delayed things.

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Apr 21, 2020 22:01:09   #
scooter1 Loc: Yacolt, Wa.
 
Longshadow wrote:
Unfortunately.
If he would have bickered, it would have just delayed things.



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Apr 22, 2020 08:07:18   #
d2b2 Loc: Catonsville, Maryland, USA
 
Sure. Like designating a person to oversee the distribution - which the Dems demanded. But it was easier for Trump to just go along with the program and then he could fire that person later so his Administration could take total control. That resulted in Ruth Chris getting $20 million of the Stimulus money and Shake Shack getting another$10 million; and both, I believe are owned by the same corporate umbrella, and they certainly do not fit the "small business" model for which the Stimulus program was designated. Bank of America, Wells Fargo and Citibank have all been cited to improper handling of their allotment of funds, for their own purposes. I am a registered Republican, and I believe there is a huge amount of crap going on with both parties.

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Apr 22, 2020 09:33:17   #
Longshadow Loc: Audubon, PA, United States
 
d2b2 wrote:
...
...
...and I believe there is a huge amount of crap going on with both parties.

MOST DEFINITELY!
Neither are saints!

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