SalivaDirect - Great news.

[reedny]

Ah, I also see another issue, couldn't figure out why I didn't see the quoted portion. The EUA you linked is not the "SalivaDirect" EUA. It is for Yales's RT-PCR test. The EUA for SalivaDirect is in my post above.

Ok thank you. It's pretty confusing - I couldn't find a date on the EUA ... and the one I linked refers to saliva testing.

 

[DMDMD]

Ok thank you. It's pretty confusing - I couldn't find a date on the EUA ... and it refers to saliva testing.

Yeah, what you quoted basically says: You could also run this test off of saliva if your doctor says its OK.

 

[DMDMD]

But (as a layman trying to understand this) ... you're always going to have testing subjects that aren't in 'acute phase'. People may be asymptomatic and claim they have a cough just to get a test. Or they may confuse their allergies with Covid symptoms. Or they may have a mild cold - and they want a test. None of those cases would be 'acute phase' Covid - so in that sense they'd be asymptomatic (for Covid) but still get a test.

This is why I don't understand why a saliva test shouldn't or couldn't be used for surveillance. They're testing asymptomatic people all the time.

This is a much longer discussion, but this essentially has to do with how diagnostic testing and decision making occurs in medicine by assigning a "prior probability" of a disease being present and assessing how a positive or negative result changes that probability.

 

[reedny]

This is a much longer discussion, but this essentially has to do with how diagnostic testing and decision making occurs in medicine by assigning a "prior probability" of a disease being present and assessing how a positive or negative result changes that probability.

I'll take your word on that. But other than in obvious Covid cases, it seems that a significant percentage of testing involves asymptomatic subjects. These are either people who are faking/misunderstanding their symptoms or actually-infected individuals who are asymptomatic (and not in the acute phase). So at least as to the SalivaDirect test, which is cheap, easy to do and delivers quick results, why not open it up and do surveillance with it?

 

[DMDMD]

I'll take your word on that. But other than in obvious Covid cases, it seems that a significant percentage of testing involves asymptomatic subjects. These are either people who are faking/misunderstanding their symptoms or actually-infected individuals who are asymptomatic (and not in the acute phase). So at least as to the SalivaDirect test, which is cheap, easy to do and delivers quick results, why not open it up and do surveillance with it?

I imagine it will be used for screening and probably soon, but they have not released the data on asymptomatic persons. We just don't know the performance of saliva collection for this test for that purpose vs nasopharyngeal screening. Could miss a significant number of people. It could be significantly better than NP screening. We just don't know ¯\_(ツ)_/¯

 

[OrangeFoo]

I imagine it will be used for screening and probably soon, but they have not released the data on asymptomatic persons. We just don't know the performance of saliva collection for this test for that purpose vs nasopharyngeal screening. Could miss a significant number of people. It could be significantly better than NP screening. We just don't know ¯\_(ツ)_/¯

I’m confused... I thought this was big news because the NBA has been using it to keep their bubble safe for a month or so now? From what I read they used PCR tests on NBA players as a counter-factual and the match rate was in the 90s?

 

[upperdeck]

yeah what i read was they found it was working at almost the same rate on teh NBA guys and it sounded like they were doing duel testing.

on the other hand if you are testing guys who dont have it all that proves is false positives not real positives.

 

[DMDMD]

I’m confused... I thought this was big news because the NBA has been using it to keep their bubble safe for a month or so now? From what I read they used PCR tests on NBA players as a counter-factual and the match rate was in the 90s?

I believe they are using it with NP swabs in NBA players as part of a study, but I don’t think their data has been released and it’s not the basis for the EUA.

 

[reedny]

I believe they are using it with NP swabs in NBA players as part of a study, but I don’t think their data has been released and it’s not the basis for the EUA.

There's a Yale article indicating they used NBA data (players from 22 teams participated).

With data from NBA study, FDA extends Emergency Use Authorization to Yale’s SalivaDirect COVID-19 test

The test is inexpensive, non-invasive and validated for use with reagents and instruments from multiple vendors, which researchers hope will minimize supply chain bottlenecks.

yaledailynews.com

The article has a quote from the lead researcher (Anne Wyllie), who stated that:

"The NBA study allows researchers to validate the test in an asymptomatic cohort, Wyllie said."

In the Yale/FDA EUA, there's also an extensive comparison of SD and NP test results (and a +/- result correlation > 90%) in the Clinical Evaluation section on pages 6, 7 and 8.

https://www.fda.gov/media/141192/download

 

[DMDMD]

There's a Yale article indicating they used NBA data (players from 22 teams participated). And there's a pretty extensive comparison of SD and NP test results (and a +/- result correlation > 90%) in the Clinical Evaluation section on pages 6, 7 and 8 of the EUA.

With data from NBA study, FDA extends Emergency Use Authorization to Yale’s SalivaDirect COVID-19 test

The test is inexpensive, non-invasive and validated for use with reagents and instruments from multiple vendors, which researchers hope will minimize supply chain bottlenecks.

yaledailynews.com

https://www.fda.gov/media/141192/download

Yes, they submitted correlation data to NP samples for 2 different NP tests, but that is not the asymptomatic cohort. This is not related to the NBA study.

From the article you attached:

"The NBA study allows researchers to validate the test in an asymptomatic cohort, Wyllie said. In addition to receiving daily testing to ensure that they have not contracted the virus, a group of players, coaches and staff heading for the NBA’s Florida bubble volunteered to offer a saliva test sample that researchers could use to verify the efficacy of SalivaDirect.

Although she could not yet report on the study itself, Wyllie pointed out that the very success of the NBA bubble in Florida has created a unique challenge for researchers studying a new coronavirus test: there are no positive cases. Before teams entered the bubble at Disney World, 25 of 351 players tested positive for the virus between June 23 and July 2. But of the more than 340 players still receiving constant tests within the bubble, zero positive tests have been recorded over the past month, according to official NBA releases."

 

[Redrum]

If this test is the real deal it’s exactly what I said we need over a vaccine for now .
The government should mass produce them
Then mail out 4 per person
Put everyone on a 4 day weekend quarantine
Test on Friday then again on Monday if 2 negatives your free to go . The spread will be over

 

[NineOneSeven]

If this test is the real deal it’s exactly what I said we need over a vaccine for now .
The government should mass produce them
Then mail out 4 per person
Put everyone on a 4 day weekend quarantine
Test on Friday then again on Monday if 2 negatives your free to go . The spread will be over

That'll work

 

[cusefan88]

If this test is the real deal it’s exactly what I said we need over a vaccine for now .
The government should mass produce them
Then mail out 4 per person
Put everyone on a 4 day weekend quarantine
Test on Friday then again on Monday if 2 negatives your free to go . The spread will be over

Using the mail you say? Interesting...

 

[rrlbees]

If this test is the real deal it’s exactly what I said we need over a vaccine for now .
The government should mass produce them
Then mail out 4 per person
Put everyone on a 4 day weekend bender.
Test on Friday then again on Monday if 2 negatives your free to go . The spread will be over

fixed it for you.

 

[Redrum]

fixed it for you.

Much better

 

[qdawgg]

I'm not staying home for 4 days to help our country out. Somewhere in the Bill of rights it says this.

 

[TexanMark]

Come away with mono or wake up fine. What a time.

Doncha know I was bulletproof at 20.

 

[DMDMD]

A little google-fu tells me this is the test SU is using in partnership with SUNY Upstate. They are apparently doing pooled saliva testing.

editable COVID-19 projects - Quadrant Biosciences

www.quadrantbiosciences.com

 

[storange]

Dr. Scott Gottlieb: Yale's new saliva coronavirus test funded by NBA could be widely rolled out

"It's also been cross-validated on just about every popular platform for doing testing," the former FDA chief told CNBC on Monday.

www.cnbc.com

 

[upperdeck]

next big step is the electronic testing that so many are working on. when the get the apps on phones or machine that you breathe into then you can get things much more normal. you want to go to a game, $5 point of entry testing is tacked on. will people be willing to do that and what price point. what else will they test for going forward?

 

[Jake]

next big step is the electronic testing that so many are working on. when the get the apps on phones or machine that you breathe into then you can get things much more normal. you want to go to a game, $5 point of entry testing is tacked on. will people be willing to do that and what price point. what else will they test for going forward?

Ha. Right now people would pay a significant premium to go to a live event. No question.

 

[dollarbill44]

If this test is the real deal it’s exactly what I said we need over a vaccine for now .
The government should mass produce them
Then mail out 4 per person
Put everyone on a 4 day weekend quarantine
Test on Friday then again on Monday if 2 negatives your free to go . The spread will be over

If it's through the mail, you will get fraudulent results. Hehehe

 

[Millhouse]

Any chance a semen test is in the works?

No reason we can’t have a little fun while finding out if we’re going to die.

It would mess up your spit test, wait no it wouldn't