SalivaDirect potential game changer (for the good)


Yes, I wrote about this last week. Unfortunately the B1G didn’t hold off. Now we Gopher fans have to suffer. Warren gets go watch his son, but B1G parents can’t. Makes no sense.
 

Te test is said to have been developed at Yale though United Health was working on a saliva teat also.
The test still has to go to a central facility for the determination making turn around time still a problem. The accuracy might be better than the nasal swab.
And its availability is not yet known so it is not a panacea.
What is really needed is a test like the pregnancy test, done at home, not too expensive and quick results.
Right now all testing is decreasing because the infrastructure, that is reagents, tubes swabs, machines etc is still lacking.
That will plague the saliva test too..
 

Biologist here. Seems like SalivaDirect simplifies the sample collection, but its still an RT-PCR test, not a rapid test. I would not assume this will change the Covid dynamic this fall.

The Covid epidemiology in college football might be more interesting than the actual competition this year.
 

I still love that we are blowing through thousands of tests on sports and there are areas of the country you can’t get tested at all lol.
 


Money talks and we all know what walks.
 

The article is nothing but click bait. Fishing for clicks from angry, crazy Big Ten fans still somehow trying to hope we’ll play this fall.

It hasn’t been proven. It was given emergency authorization, just like hydroxychloroquine. Gee, wonder who forced it to be approved. Probably no political motivation, at all.
 

Te test is said to have been developed at Yale though United Health was working on a saliva teat also.
The test still has to go to a central facility for the determination making turn around time still a problem. The accuracy might be better than the nasal swab.
And its availability is not yet known so it is not a panacea.
What is really needed is a test like the pregnancy test, done at home, not too expensive and quick results.
Right now all testing is decreasing because the infrastructure, that is reagents, tubes swabs, machines etc is still lacking.
That will plague the saliva test too..

The FDA has been the limiting factor all along. This stuff isn’t rocket science. They have test sensitivity criteria that have been difficult to meet with the rapid, paper based antigen tests.

The good news is opinion is “evolving” as the math gets explained and absorbed, and it starts to make more sense to invest billions (or a trillion) in prevention rather than cleaning up fiscal messes.

Bureaucracy moves slowly in the best of times.
 

The article is nothing but click bait. Fishing for clicks from angry, crazy Big Ten fans still somehow trying to hope we’ll play this fall.

It hasn’t been proven. It was given emergency authorization, just like hydroxychloroquine. Gee, wonder who forced it to be approved. Probably no political motivation, at all.

Academic viewpoint, rationale for lower sensitivity but cheap antigen testing



Dr Herrera viewpoint, and on regulatory hurdles

 



The key to the saliva test is still how fast results can be processed at a lab.

As I understand it, more labs and different types of labs will be able to process the tests. but you still have to get the test to the lab.

Theoretically, if - let's say - the U of MN hospital could do the processing, then the U could test athletes and get quicker results. the question is how much quicker this would be than the current system.

But, if you are not next door to a lab, or don't have a lab capable of processing tests in your community, those tests will still have to get delivered to the lab - presumably through the postal service. (which is having its own issues these days........)

So, it appears the most direct benefit of the saliva test would be for groups like D1 College Teams or Pro teams that have the resources and have capable labs in close proximity.

for a guy like me who lives in a smaller community, the advantage would be that I can do my own test at a lesser cost - but I still have to mail in the test and wait for results.
 

I still love that we are blowing through thousands of tests on sports and there are areas of the country you can’t get tested at all lol.

It would be easy to blame politicians but per Dr. Herrera and others it is misguided, overly stringent criteria of the FDA administrators and scientific experts that has prevented wide use of antigen tests, and even more damning only just recently approved at home testing as a viable avenue.
 

I'm in the camp that it was a good call to hold off on playing this fall. In addition start again a year from now as opposed to starting this spring/winter.

There are way too many unknowns that may cause long time issues with the players along with the coaches. To me its like well the water looks safe, but yet there has been shark sightings in the water as well. Hopefully by testing the water it should be safe to jump in. Not everyone is going to get gobbled up by the sharks, but does that make it right?
 

The article is nothing but click bait. Fishing for clicks from angry, crazy Big Ten fans still somehow trying to hope we’ll play this fall.

It hasn’t been proven. It was given emergency authorization, just like hydroxychloroquine. Gee, wonder who forced it to be approved. Probably no political motivation, at all.
So your against the president trying to get a cheap, easier to use, and maybe quicker test out to the public because he might get a little good publicity for it?
 



There are POC tests available that require processing via a small device/“mobile platform”, eg Abbott and others. My expectation was the leagues would invest in these devices or expand university lab operations for more traditional brain skewer PCR tests but perhaps found special testing for athletes, particularly in an environment of perceived exploitation, politically untenable.

A synopsis of point of care testing from the CDC


 

So your against the president trying to get a cheap, easier to use, and maybe quicker test out to the public because he might get a little good publicity for it?

It wouldn’t be out of the realm of possibility the ID NOW test, for example, will get blackballed because it is associated with use at the White House. These are crazy times.
 

Academic viewpoint, rationale for lower sensitivity but cheap antigen testing



Dr Herrera viewpoint, and on regulatory hurdles

Neither of these have anything to do with how effective the the particular product/brand of test from the OP is. Agree 1000% with the first video, and never implied anything to the contrary of that.
 

It would be easy to blame politicians but per Dr. Herrera and others it is misguided, overly stringent criteria of the FDA administrators and scientific experts that has prevented wide use of antigen tests, and even more damning only just recently approved at home testing as a viable avenue.
Not going to waste my time digging into a couple fringe opinions. I’ll just go with the proven scientists at the FDA and other agencies.
 

So your against the president trying to get a cheap, easier to use, and maybe quicker test out to the public because he might get a little good publicity for it?
No. You missed the point completely.

The point is if he test actually works. Just claiming it works, doesn’t do anything. I can claim anything I want.
 

The FDA has been the limiting factor all along. This stuff isn’t rocket science. They have test sensitivity criteria that have been difficult to meet with the rapid, paper based antigen tests.

The good news is opinion is “evolving” as the math gets explained and absorbed, and it starts to make more sense to invest billions (or a trillion) in prevention rather than cleaning up fiscal messes.

Bureaucracy moves slowly in the best of times.
It is not only sensitivity but accuracy.
The coronavirus also causes the common cold so many people at a given time have that virus but not the covid 19 in their upper airway.
The test has to be sensitive to assure there are no or very, very few false negatives.
The most commonly used rapid test has a 20% false negative rate. If the virus is uncommon in a population statistics show that then the false negative rate is more than one in five.
The FDA is bot the villain but the CDC did royally screw up.
 

The A coronavirus also causes the common cold so many people at a given time have that virus but not the covid 19 in their upper airway.

Important distinction, especially with regards to your broader point.
 


Not going to waste my time digging into a couple fringe opinions. I’ll just go with the proven scientists at the FDA and other agencies.

If I could do the LOL, thumbs up, and love emojis I would.

You realize the FDA has been changing their views on this in recent weeks?
 

It is not only sensitivity but accuracy.
The coronavirus also causes the common cold so many people at a given time have that virus but not the covid 19 in their upper airway.
The test has to be sensitive to assure there are no or very, very few false negatives.
The most commonly used rapid test has a 20% false negative rate. If the virus is uncommon in a population statistics show that then the false negative rate is more than one in five.
The FDA is bot the villain but the CDC did royally screw up.

The sensitivity and specificity issues you referenced would be mostly invalidated by the easy ability to quickly confirm a false positive, at home. Think of home pregnancy tests - one might want to confirm a positive (or negative). Cross reactivity shouldn't be a major problem.

The specificity numbers I’ve seen are 97-98+% and sensitivity obviously varies to sub 80% in some cases but there are a couple huge caveats to that. Low sensitivity is a secondary problem, considering our current testing regimen is delivering results days to weeks after the individual becomes infectious. Furthermore the lower sensitivity of antigen tests is minimized by the fact people shedding infectious doses of virus are still highly likely to test positive. The paper antigen tests mentioned by Dr. Mina and Herrera was validated to be near equivalent to PCR during that phase of infection.
 

If it is ok with you pompous I am going to wait until the results are confirmed by the CDC and FDA , Fauci agrees and the data published in a respected scientific journal.
 

If it is ok with you pompous I am going to wait until the results are confirmed by the CDC and FDA , Fauci agrees and the data published in a respected scientific journal.

There is plenty of data out there from the CDC on existing and approved POC tests. The current movement to cheap, at home testing is about overcoming what are in this case seemingly misguided regulatory barriers to these currently unapproved tests.

It seems as obvious as travel bans, masks, before they were belatedly approved by the CDC, WHO, and Fauci.

The clock is ticking. The better question is what is the downside vs the current state of affairs?
 

I believe there might be three coronaviruses that cause the common cold.

Oh, absolutely, there are multiple viruses and multiple strains within each. Your initial statement could be read to imply that Sars-Cov-2 ("the coronavirus") could also cause the common cold, and I wanted to make sure it was clarified that that is not the case.
 

If it is ok with you pompous I am going to wait until the results are confirmed by the CDC and FDA , Fauci agrees and the data published in a respected scientific journal.
Correct
 

Oh, absolutely, there are multiple viruses and multiple strains within each. Your initial statement could be read to imply that Sars-Cov-2 ("the coronavirus") could also cause the common cold, and I wanted to make sure it was clarified that that is not the case.
I am aware of that.
The woman researcher who first identified the unique shape of the virus using an electron microscope got her samples from the saliva of people with colds.
Given it was a woman no one in the establishment at first believed her results.
 

I am aware of that.
The woman researcher who first identified the unique shape of the virus using an electron microscope got her samples from the saliva of people with colds.
Given it was a woman no one in the establishment at first believed her results.
Well of course. Women can’t even vote, so they obviously can’t do science.

.... wait, what???!?!
 

Dr. Osterholm was on WCCO this morning with Dave Lee.

he did not sound as excited about the saliva test. He said that some labs would not be able to process the test (didn't catch exactly why). He also questioned what the cost of the test would be by the time it's able to be offered to the public.
 




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