SalivaDirect - Great news.

[rrlbees]

I don’t believe the current EUA covers pool testing. Nor does it cover asymptomatic screening. It is authorized as a diagnostic test in symptomatic persons.

that takes it down several notches. No asymptomatic testing? Useless as a test for a football team on a regular basis.

 

[kcsu]

The test was developed by Yale. It is a significant development.

Results same day

Inexpensive

85- 95% accurate which is in line with or better than current test.

Because of the frequency it can be used, the speed of results it is actually as good if not better than the current protocol.

Its not an end all but because Yale is making this an open sourced solution it will end up being a major game changer.

 

[cuse10]

The 20 year old me at college: giving free saliva coed testing.

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

 

[rrlbees]

I don’t believe the current EUA covers pool testing. Nor does it cover asymptomatic screening. It is authorized as a diagnostic test in symptomatic persons.

do you know the typical duration for going from EUA to broad use?

 

[TheCusian]

that takes it down several notches. No asymptomatic testing? Useless as a test for a football team on a regular basis.

If it’s that cheap and that effective, they’ll face a lot of pressure from a lot of places to approve it for asymptomatic very quickly

 

[rrlbees]

If it’s that cheap and that effective, they’ll face a lot of pressure from a lot of places to approve it for asymptomatic very quickly

hope so.

 

[DMDMD]

do you know the typical duration for going from EUA to broad use?

This particular method can be scaled up immediately since it uses very few supplies and pretty much any CLIA certified lab that already runs PCR tests can do it. They just email the creators of the test for a license.

 

[rrlbees]

This particular method can be scaled up immediately since it uses very few supplies and pretty much any CLIA certified lab that already runs PCR tests can do it. They just email the creators of the test for a license.

so the fda doesn’t have to make any further approvals?

 

[DMDMD]

so the fda doesn’t have to make any further approvals?

It basically has a temporary approval, but it is not "FDA Approved." But no, the protocol can be used today if you get a license from the guys at Yale.

 

[kcsu]

It is approved under an emergency authorization. It doesn't require any additional approval from the FDA for it to be used.

 

[rrlbees]

It basically has a temporary approval, but it is not "FDA Approved." But no, the protocol can be used today if you get a license from the guys at Yale.

my question and your answer may be going past each other. Originally you indicated it could be used for symptomatic use but not asymptomatic use because it was an EUA. Which to me says it’s not much use for a football team who wants to test everyone. Now it seems like you are saying if you get a license from Yale, you can use it for symptomatic and asymptomatic?

 

[kcsu]

my question and your answer may be going past each other. Originally you indicated it could be used for symptomatic use but not asymptomatic use because it was an EUA. Which to me says it’s not much use for a football team who wants to test everyone. Now it seems like you are saying if you get a license from Yale, you can use it for symptomatic and asymptomatic?

Im pretty sure that is correct. My oldest Daughter is at Yale ill ask her to ask.

 

[Chip]

my question and your answer may be going past each other. Originally you indicated it could be used for symptomatic use but not asymptomatic use because it was an EUA. Which to me says it’s not much use for a football team who wants to test everyone. Now it seems like you are saying if you get a license from Yale, you can use it for symptomatic and asymptomatic?

I'm guessing Yale has about 130 unread emails this morning.

Maybe one from each conference too.

 

[storange]

With some innovation could this not be a path to opening up schools , stadiums ? Talking maybe a few months down the line or am I getting crazy.

 

[DMDMD]

my question and your answer may be going past each other. Originally you indicated it could be used for symptomatic use but not asymptomatic use because it was an EUA. Which to me says it’s not much use for a football team who wants to test everyone. Now it seems like you are saying if you get a license from Yale, you can use it for symptomatic and asymptomatic?

Sorry. Technically, it has an EUA as a diagnostic test: "SalivaDirect is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container rom individuals suspected of COVID-19 by their healthcare provider. (emphasis mine)."

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

From their website:
Asymptomatic detection. Most available SARS-CoV-2 tests have not been validated to detect asymptomatic infections, which is the primary goal of large-scale population screening and surveillance. We are working to see how SalivaDirect compares to swabs tested via conventional methods for detecting these cases, in partnership with the National Basketball Association and National Basketball Players Association. See below.

About our Test Development

Visit the post for more.

covidtrackerct.com

So, again technically, it is not authorized for screening asymptomatic persons. Could you do that? I suppose, but I don't believe they have presented data to know how sensitive or specific it would be in that scenario.

 

[DMDMD]

With some innovation could this not be a path to opening up schools , stadiums ? Talking maybe a few months down the line or am I getting crazy.

I'm doubtful any traditional RT-PCR based test will be, based purely on the fact that such tests require a sample to be on a thermocycler for 2-3 hours and there really isn't any way to reduce that further.

The kind of test that will allow what you're thinking will be either a rapid antigen test or a LAMP based test like this one columbia is developing. These results will be available in 30 minutes:

New COVID-19 Saliva Test Is Born in Columbia Fertility Clinic

Columbia fertility experts have developed a one-step saliva test for diagnosing COVID-19 that could expand access to testing.

www.cuimc.columbia.edu

 

[rrlbees]

Sorry. Technically, it has an EUA as a diagnostic test: "SalivaDirect is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container rom individuals suspected of COVID-19 by their healthcare provider. (emphasis mine)."

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

From their website:
Asymptomatic detection. Most available SARS-CoV-2 tests have not been validated to detect asymptomatic infections, which is the primary goal of large-scale population screening and surveillance. We are working to see how SalivaDirect compares to swabs tested via conventional methods for detecting these cases, in partnership with the National Basketball Association and National Basketball Players Association. See below.

About our Test Development

Visit the post for more.

covidtrackerct.com

So, again technically, it is not authorized for screening asymptomatic persons. Could you do that? I suppose, but I don't believe they have presented data to know how sensitive or specific it would be in that scenario.

so could a college sports team, like SU, use it for their 3x a week testing in season?

 

[Chip]

"SalivaDirect is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container rom individuals suspected of COVID-19 by their healthcare provider. (emphasis mine)."

 

[DMDMD]

so could a college sports team, like SU, use it for their 3x a week testing in season?

You need a CLIA certified lab to run this sort of test. I'm not familiar with what arrangement SU has, or with whom, I would presume with SUNY Upstate? If you had a lab committed to doing it, it would make it somewhat easier. And the players would probably appreciate not having a cotton swab shoved back to their brain every couple days.

It uses less material, which should help avoid bottlenecks due to shortages of swabs, transport media or RNA extraction kits, all of which have been hard to come by at one time or another.

edit: to actually answer your question: it has advantages for the players and labs that would run the tests. But, there still isn't actual data to let us know whether its an effective screening test in an asymptomatic population

 

[kcsu]

You need a CLIA certified lab to run this sort of test. I'm not familiar with what arrangement SU has, or with whom, I would presume with SUNY Upstate? If you had a lab committed to doing it, it would make it somewhat easier. And the players would probably appreciate not having a cotton swab shoved back to their brain every couple days.

It uses less material, which should help avoid bottlenecks due to shortages of swabs, transport media or RNA extraction kits, all of which have been hard to come by at one time or another.

Plus the cost is 70-80% less.

 

[reedny]

so could a college sports team, like SU, use it for their 3x a week testing in season?

[Edit]

Here's a link to the EUA.

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

 

[DMDMD]

Plus the cost is 70-80% less.

Yes, this test should cost about 5 bucks a pop.

Even better, they will be testing whether it works by pooling samples. So you could mix the spit of 5 people, run 1 test in 1 tube and see whether anyone in that group is positive, assuming its an effective test for screening and assuming the pooling actually works. In that case, you could test a whole football team for like, 100 bucks.

 

[DMDMD]

I don't see anything in the (A)EUA limiting tests to symptomatic subjects. It says COV-2 RNA saliva testing can be done "in a health care setting ...when determined to be appropriate by a healthcare provider". That could mean any 'high-risk' situation - like a team. Here's the language, and a link to the EUA.

The test is also for use with raw saliva specimens that are collected using a sterile container in a healthcare setting when determined to be appropriate by a healthcare provider. . . . Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection.

https://www.fda.gov/media/136602/download

(emphasis is mine).

Its in the first paragraph on the page you linked

"intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in respiratory specimens (nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, mid-turbinate nasal swabs, BALs, and sputum) from individuals suspected of COVID-19 by a healthcare professional."

 

[DMDMD]

Yes but then the next paragraph - the one authorizing saliva testing - has a different standard. That's the one I was referring to.

The test is also for use with raw saliva specimens that are collected using a sterile container in a healthcare setting when determined to be appropriate by a healthcare provider.

Appropriate could be a high-risk setting where subjects are required to have close contact, like a team (NBA) or meat-packing plant.

Sure, yeah. You could do it so long as you had a lab willing to run it for you, but you'd have to recognize that you are doing so with a complete absence of data on the performance of the test in that scenario.

As they note under the "limitations" section for the data reviewed in the EUA, "Testing of saliva specimens is limited to patients with symptoms of COVID19." They have not yet submitted any data regarding asymptomatic patients.

 

[DMDMD]

Yes but then the next paragraph - the one authorizing saliva testing - has a different standard. That's the one I was referring to:

The test is also for use with raw saliva specimens that are collected using a sterile container in a healthcare setting when determined to be appropriate by a healthcare provider.

Appropriate could be a high-risk setting where subjects are required to have close contact, like a team (NBA) or meat-packing plant.

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.