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Saliva Covid test developed by Yale approved by FDA
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Last: 5 yr ago by Iowaggie
Ok. Now to HCQ.
It takes a special kind of brainwashed useful idiot to politically defend government fraud, waste, and abuse.
Dang, this should go one the good news thread. Is this not big? Am I overstating it's importance?
fast easy cheap quick non nasal brain stabbing testing is a game changer
Great
How long to process once saliva has been collected?
The processing with Nasal has been very slow. 3-4 days is not acceptable.
How long to process once saliva has been collected?
The processing with Nasal has been very slow. 3-4 days is not acceptable.
what's the sensitivity / specificity?
cone said:
what's the sensitivity / specificity?
11
Complete Idiot said:cone said:
what's the sensitivity / specificity?
11
That's great news! Much better than 10
Pretty sure I've heard of other saliva tests well before now (ASU?) so what makes this a big deal? The FDA backing and ability to scale with low costs?
ESPN had a pretty good writeup on how it came about.
https://www.espn.com/nba/story/_/id/29667299/fda-allowing-saliva-based-test-funded-nba?platform=amp&__twitter_impression=true
Just spitballing (no pun intended) here but what if sports facilities like Kyle Field made these available at no or low charge to people coming through the gates? This could be part of continued maintenance on our way towards some semblance of herd immunity. I mean right now just to speed up the lag in getting results would be great. This ESPN article said the NBA found the saliva results to be as accurate as the nasal swab.
https://www.espn.com/nba/story/_/id/29667299/fda-allowing-saliva-based-test-funded-nba?platform=amp&__twitter_impression=true
Just spitballing (no pun intended) here but what if sports facilities like Kyle Field made these available at no or low charge to people coming through the gates? This could be part of continued maintenance on our way towards some semblance of herd immunity. I mean right now just to speed up the lag in getting results would be great. This ESPN article said the NBA found the saliva results to be as accurate as the nasal swab.
This seems huge. Path to normalcy.
This saliva test has to be processed by a lab and takes 2-3 hours. There are other saliva tests in the the works, like the one from Sorento, that do not require a lab and give results in 30 minutes. Just a paper strip that changes color.
This test has two advantages:
1) Collection of saliva is much easier than swab, and doesn't need media component that swabs were placed into after collection (reduces costs and personnel needed to sample collection).
2) takes away RNA isolation/purification step. During the initial testing ramp-up, there was a run on these kits and supplies that was a major bottleneck. This reduces costs, time (RNA isolation/purification can take 2-3 hrs), and required personnel to do the actual isolation which is the most critical step.
Its still the same qRT-PCR test, and has to be run in an approved lab. That does not go away and is not rapid (takes 2-4 hours between sample prep, running the PCR and then data analysis). But it cuts the time in half.
1) Collection of saliva is much easier than swab, and doesn't need media component that swabs were placed into after collection (reduces costs and personnel needed to sample collection).
2) takes away RNA isolation/purification step. During the initial testing ramp-up, there was a run on these kits and supplies that was a major bottleneck. This reduces costs, time (RNA isolation/purification can take 2-3 hrs), and required personnel to do the actual isolation which is the most critical step.
Its still the same qRT-PCR test, and has to be run in an approved lab. That does not go away and is not rapid (takes 2-4 hours between sample prep, running the PCR and then data analysis). But it cuts the time in half.
Good for Yale to have caught up.
Saliva testing for COVID isn't new.
https://www.the-scientist.com/news-opinion/saliva-tests-how-they-work-and-what-they-bring-to-covid-19-67720
This one is from April.
https://www.the-scientist.com/news-opinion/first-saliva-test-for-covid-19-approved-for-emergency-use-by-fda-67416
I'm so tired of everyone acting like every PR piece announcing "my new thing" is going to magically solve all the problems. Of course Yale doesn't mention Rutgers beat them to the punch on a saliva test by 4 months. Lol
Saliva testing for COVID isn't new.
https://www.the-scientist.com/news-opinion/saliva-tests-how-they-work-and-what-they-bring-to-covid-19-67720
This one is from April.
https://www.the-scientist.com/news-opinion/first-saliva-test-for-covid-19-approved-for-emergency-use-by-fda-67416
I'm so tired of everyone acting like every PR piece announcing "my new thing" is going to magically solve all the problems. Of course Yale doesn't mention Rutgers beat them to the punch on a saliva test by 4 months. Lol
If you read the FDA release, you would note it says this is the FIFTH approved FDA test that uses saliva. However, if you read the details of the links you provided, and the details about SalivaDirect, you can see there are differences - the early ones, like the RUtgers one you linked, can only be tested on a piece of special equipment at RUtgers and needed a prescription. Or, they required nucleic acid preservatives while SalivaDirect does not, SalivaDirect does not use nucleic acid extraction, and they've shared this with all labs using a variety of reagents and instruments so it is more open to all. It appears this saliva test is more sensitive and better validated to prove it is closer, or equal, in accuracy to the swab - but I'm not 100% sure about that compared to the earlier saliva tests. I also feel this is different than most PR pieces released by pharma companies (such as a few that leaked "we think we have cure" back in July, saw their obscure stock skyrocket, then they disappear) because this is Yale, open source, and does not appear to be driven by profit goals. Having said all that, I don't know for sure if it will make a huge change but it sure sounds like a positive to allow more to get tested which in turn should lower positivity rates - which people seem to find important. Also, while SalivaDirect is a step forward even compared to the prior saliva tests, it does require lab analysis and there are additional saliva tests planned that may not even need the lab test - you might get results immediately. I don't know what that type of test would do with positive test cases - would people even report their positive? - but it may lead to more asymptomatic people determining they are carrying and they could isolate better? Every step forward is a positive and helps us get a handle on this, which should calm the populace - if they start reading for themselves and not relying on 24 hour TV news sources or click bait online media.BiochemAg97 said:
Good for Yale to have caught up.
Saliva testing for COVID isn't new.
https://www.the-scientist.com/news-opinion/saliva-tests-how-they-work-and-what-they-bring-to-covid-19-67720
This one is from April.
https://www.the-scientist.com/news-opinion/first-saliva-test-for-covid-19-approved-for-emergency-use-by-fda-67416
I'm so tired of everyone acting like every PR piece announcing "my new thing" is going to magically solve all the problems. Of course Yale doesn't mention Rutgers beat them to the punch on a saliva test by 4 months. Lol
I hope they've improved it since a couple months ago. My friend was running the Navy's testing team and said the saliva test was ***** But things are moving fast.
Universities have plenty of motivation to toot their own horn. It is just a different motivation from increase share price.
Agree that more tests are always good and that Yale's is validated on multiple vendors reagents. Not sure how much that will really help because lab A usually has contracts with Vendor 1 to supply reagent. If they can't get reagent from vendor 1, they are going to have a hard time just switching to vendor 2. They would need to revalidate everything with vendor 2s reagents. If vendor 1 had a chronic supply problem, then the switch ,makes sense. If you just ran out and you shipment doesn't come in until tomorrow, it won't make much a difference.
Agree that more tests are always good and that Yale's is validated on multiple vendors reagents. Not sure how much that will really help because lab A usually has contracts with Vendor 1 to supply reagent. If they can't get reagent from vendor 1, they are going to have a hard time just switching to vendor 2. They would need to revalidate everything with vendor 2s reagents. If vendor 1 had a chronic supply problem, then the switch ,makes sense. If you just ran out and you shipment doesn't come in until tomorrow, it won't make much a difference.
For clarity, the Rutgers test was authorized as a lab developed test, thus The only at Rutgers. The "specialized piece of equipment" is widely available in many many labs and the TAQPath assay has some of the largest production volumes (about 10 million per week globally) of any of the available tests. Yes each lab wanting to do a spit test with TAQPath would have had to validate and submit to the FDA, until someone got EUA as something other than a lab developed test.Complete Idiot said:If you read the FDA release, you would note it says this is the FIFTH approved FDA test that uses saliva. However, if you read the details of the links you provided, and the details about SalivaDirect, you can see there are differences - the early ones, like the RUtgers one you linked, can only be tested on a piece of special equipment at RUtgers and needed a prescription. Or, they required nucleic acid preservatives while SalivaDirect does not, SalivaDirect does not use nucleic acid extraction, and they've shared this with all labs using a variety of reagents and instruments so it is more open to all. It appears this saliva test is more sensitive and better validated to prove it is closer, or equal, in accuracy to the swab - but I'm not 100% sure about that compared to the earlier saliva tests. I also feel this is different than most PR pieces released by pharma companies (such as a few that leaked "we think we have cure" back in July, saw their obscure stock skyrocket, then they disappear) because this is Yale, open source, and does not appear to be driven by profit goals. Having said all that, I don't know for sure if it will make a huge change but it sure sounds like a positive to allow more to get tested which in turn should lower positivity rates - which people seem to find important. Also, while SalivaDirect is a step forward even compared to the prior saliva tests, it does require lab analysis and there are additional saliva tests planned that may not even need the lab test - you might get results immediately. I don't know what that type of test would do with positive test cases - would people even report their positive? - but it may lead to more asymptomatic people determining they are carrying and they could isolate better? Every step forward is a positive and helps us get a handle on this, which should calm the populace - if they start reading for themselves and not relying on 24 hour TV news sources or click bait online media.BiochemAg97 said:
Good for Yale to have caught up.
Saliva testing for COVID isn't new.
https://www.the-scientist.com/news-opinion/saliva-tests-how-they-work-and-what-they-bring-to-covid-19-67720
This one is from April.
https://www.the-scientist.com/news-opinion/first-saliva-test-for-covid-19-approved-for-emergency-use-by-fda-67416
I'm so tired of everyone acting like every PR piece announcing "my new thing" is going to magically solve all the problems. Of course Yale doesn't mention Rutgers beat them to the punch on a saliva test by 4 months. Lol
Yale is still limited to Yale's labs and labs "authorized by Yale". Maybe easier for a small lab to just certified with Yale than FDA, but the large labs could easily have submitted their own authorizations to FDA like Rutgers months ago. And I doubt Rutgers was trying to keep anything secret.
Well, if this doesn't move the ball forward then that is disappointing. Based on what I read, it seemed like an improvement and would make it easier to get tested - especially in areas of the world low on supply of what is needed to swab. I guess we wouldn't know if it helps much for at least a month, by which time cases may be dropped everywhere in America anyway. I'll still remain positive because selfishly, I'd rather spit than get brain stabbed provided they are equally accurate.
Complete Idiot said:
Well, if this doesn't move the ball forward then that is disappointing. Based on what I read, it seemed like an improvement and would make it easier to get tested - especially in areas of the world low on supply of what is needed to swab. I guess we wouldn't know if it helps much for at least a month, by which time cases may be dropped everywhere in America anyway. I'll still remain positive because selfishly, I'd rather spit than get brain stabbed provided they are equally accurate.
More test options are good and I am not saying this one isn't going to help. It just seems the hype is a bit exaggerated.
Maybe I am just a bit jaded having seen many of these testing type press releases that really haven't been more than incremental improvements to the testing situation.
Maybe it's the British version, like colour, realisation, or maths.94chem said:mesocosm said:
But why do we want more testing? It just results in more cases
Does Yale not know how to spell receive?
BiochemAg97 said:
Good for Yale to have caught up.
Saliva testing for COVID isn't new.
https://www.the-scientist.com/news-opinion/saliva-tests-how-they-work-and-what-they-bring-to-covid-19-67720
This one is from April.
https://www.the-scientist.com/news-opinion/first-saliva-test-for-covid-19-approved-for-emergency-use-by-fda-67416
I'm so tired of everyone acting like every PR piece announcing "my new thing" is going to magically solve all the problems. Of course Yale doesn't mention Rutgers beat them to the punch on a saliva test by 4 months. Lol
Harvard also has one that was to be a cheap daily alternative that was not as strong as the current test, but claimed it was better because frequency of testing with frequent, cheaper less sensitive instrument was better than a stronger instrument that most people can't use on themself and wouldn't get results quickly.
If someone really is interested in that test, they can google search Michael Mina, Harvard.