SalivaDirect potential game changer (for the good)

[upnorthkid]

You have to look at what the test is actually doing. It will detect people in the infectious phase with high sensitivity. It is not as sensitive in the very early phase and tail phase whereas PCR will amplify very low levels of RNA that are less relevant. The sensitivity issue is a red herring as Dr Mina and others eloquently explain.

If you’re going to argue testing is important but also argue people aren’t going to do it, well that seems like an incongruous and illogical position, We should be pulling out all the stops to squash outbreaks and future epidemics earlier.

If you’re worried about false negatives are you not concerned about very slow turnaround? Symptomatics will stay home, already. We’re trying to catch presympomatics, primarily. PCR, unless POC machinery and materials becomes cheap and widespread cannot do that with enough speed or convenience, not to mention cost.

bold 1: you are absolutely correct in the world of theoretical biology. Show me the test that does truly catch it at that point and you have something and I would 100% be for that. Sensitivity is not a red herring, but is an actual incredibly important issue. Yeah it's wonderfully fantastic and would work to get the 20 cups of instant coffee (using Dr. Mina's analogy, which is quite apt) if you can actually get a test that does that. I don't think anyone is trying to argue with you that that would be great if we have that test become available. It's not and so again, arguing theoretical biology doesn't do us any good.

bold 2: Testing is important. we should all be doing it if we are able. We aren't all doing it. You know this and I know this. Testing is a non-living thing focused on pure biology/science and you can order whatever you want. People are different. Millions want tests. Millions don't want their data distributed and believe its a free country to do what they want. I would love it if we could roll out a national testing system where all people would be able to and be willing to be tested. It isn't likely to happen here based on what evidence we have from a sociology/human psychology. That's all I've said and see zero reason that is illogical (the same could be applied to vaccinations, preventative screening recommendations, etc. that millions of people opt out of every year despite guidance recommendations).

bold 3: obviously. I would again love for having the rapid test. I said as much in the last post. Show me one that does/will so and we'd all agree with you. No one (logical) is trying to argue with you that having a rapid test would be awesome if it works at a solid sensitivity (I'm not talking 95% or something asinine, but something reasonable) to screen and then confirm positive results. I don't know why you're thinking I don't support that concept. From an FDA standpoint, there is no barrier to a company making one and showing a proof of concept model. To argue that it is a financial hurdle/regulatory barrier only goes so far as if your test gets to a reasonable standard, it would get approved and make money if you're the first to market. They happened for HIV and were approved.

 

[upnorthkid]

Workplace requirements will go the furthest I believe. IDK about you, but a good portion of those who are resisting masks are 35+ (not all of them, but still) and I would not be surprised if a decent majority of them would also oppose regular testing...

I agree based on experience (numerous people we would like to admit/screen at the hospital refuse testing)

 

[Pompous Elitist]

bold 1: you are absolutely correct in the world of theoretical biology. Show me the test that does truly catch it at that point and you have something and I would 100% be for that. Sensitivity is not a red herring, but is an actual incredibly important issue. Yeah it's wonderfully fantastic and would work to get the 20 cups of instant coffee (using Dr. Mina's analogy, which is quite apt) if you can actually get a test that does that. I don't think anyone is trying to argue with you that that would be great if we have that test become available. It's not and so again, arguing theoretical biology doesn't do us any good.

bold 2: Testing is important. we should all be doing it if we are able. We aren't all doing it. You know this and I know this. Testing is a non-living thing focused on pure biology/science and you can order whatever you want. People are different. Millions want tests. Millions don't want their data distributed and believe its a free country to do what they want. I would love it if we could roll out a national testing system where all people would be able to and be willing to be tested. It isn't likely to happen here based on what evidence we have from a sociology/human psychology. That's all I've said and see zero reason that is illogical (the same could be applied to vaccinations, preventative screening recommendations, etc. that millions of people opt out of every year despite guidance recommendations).

bold 3: obviously. I would again love for having the rapid test. I said as much in the last post. Show me one that does/will so and we'd all agree with you. No one (logical) is trying to argue with you that having a rapid test would be awesome if it works at a solid sensitivity (I'm not talking 95% or something asinine, but something reasonable) to screen and then confirm positive results. I don't know why you're thinking I don't support that concept. From an FDA standpoint, there is no barrier to a company making one and showing a proof of concept model. To argue that it is a financial hurdle/regulatory barrier only goes so far as if your test gets to a reasonable standard, it would get approved and make money if you're the first to market. They happened for HIV and were approved.

They claim to have internal validation data vs PCR. Obviously that needs to be vetted by regulators.

That’s why reporting requirements are a roadblock, and unhelpful. Community surveillance can still be done as sloppily as it is today via hospital and community PCR confirmation, in addition to the at home non-reportable screeners.

Again, the sensitivity data is lower because it misses the less relevant or totally irrelevant positives on the tail. The patients shedding RNA for weeks and months that are (likely) no longer infectious.

 

[Pompous Elitist]

Workplace requirements will go the furthest I believe. IDK about you, but a good portion of those who are resisting masks are 35+ (not all of them, but still) and I would not be surprised if a decent majority of them would also oppose regular testing...

I agree, the older crowd is most resistant to masks in public places. However, I’d argue young people are much worse in private or social settings. They are more docile and accommodating than “old white racist bastards - hat tip to Mplsgopher - at business places, clinics, etc.

 

[MplsGopher]

At this point, it should be an obvious red flag that PE is fighting so hard to remove the reporting aspect, without giving a good, logical reason why.

It would seem simply to be that, whatever maximizes his clients‘ profits is his (lobbying) job.

That just entrenches me further in, that they must not be removed.

 

[upnorthkid]

They claim to have internal validation data vs PCR. Obviously that needs to be vetted by regulators.

That’s why reporting requirements are a roadblock, and unhelpful. Community surveillance can still be done as sloppily as it is today via hospital and community PCR confirmation, in addition to the at home non-reportable screeners.

Again, the sensitivity data is lower because it misses the less relevant or totally irrelevant positives on the tail. The patients shedding RNA for weeks and months that are (likely) no longer infectious.

Then validate it and we’ll talk. It’s great to speculate on it but there’sa reason to validate first. I’m all for it If it works and is as good as pcr. Reporting is highly important and to dismiss it foolhardy given if there’s no follow up or person to discuss results, you risk losing your power to make good epidemiological decisions.

 

[MNGopher23]

Hell, I got the rapid test at the Urgency Room this past Friday and had my results in 16 minutes. They also said that negative tests were roughly 98.6% accurate (if I recall correctly). Why can't the Big10, especially the Gophers, get their hands on one of the Abbott rapid test machines?

 

[STPGopher]

https://www.theonion.com/best-methods-for-staying-safe-from-coronavirus-1842272448

 

[Pompous Elitist]

Then validate it and we’ll talk. It’s great to speculate on it but there’sa reason to validate first. I’m all for it If it works and is as good as pcr. Reporting is highly important and to dismiss it foolhardy given if there’s no follow up or person to discuss results, you risk losing your power to make good epidemiological decisions.

No offense, but delayed PCR test results, ie the situation in every hot spot to date , are worthless for minimizing spread.

We are currently missing at least 10x the amount of actual infections rendering your argument null and void. This would not replace PCR testing,

Your concern seems to be the sensitivity and I agree this would be valid if the low sensitivity was the case during the exponential viral replication and early tail phase of disease. Their claim (which needs to be independently validated, is their test is sensitive vs PCR in the most critical phase of infection.

 

[Pompous Elitist]

Hell, I got the rapid test at the Urgency Room this past Friday and had my results in 16 minutes. They also said that negative tests were roughly 98.6% accurate (if I recall correctly). Why can't the Big10, especially the Gophers, get their hands on one of the Abbott rapid test machines?

That was my frustration. There are POC systems available. Their concern is liability and media scrutiny, and probably some other items.

 

[MNGopher23]

That was my frustration. There are POC systems available. Their concern is liability and media scrutiny, and probably some other items.

It's frustrating to say the least. But, you are 100% correct. It all comes down to liability and perception.

 

[upnorthkid]

No offense, but delayed PCR test results, ie the situation in every hot spot to date , are worthless for minimizing spread.

We are currently missing at least 10x the amount of actual infections rendering your argument null and void. This would not replace PCR testing,

Your concern seems to be the sensitivity and I agree this would be valid if the low sensitivity was the case during the exponential viral replication and early tail phase of disease. Their claim (which needs to be independently validated, is their test is sensitive vs PCR in the most critical phase of infection.

duh? No one is arguing that.

and your testing would eliminate this?

and if so, I'm all for it. You're arguing with the wrong person. I agree with you that the test should be granted if it does what it says it does. Havent argued with that to date. I just have yet to see a test which has proven they do that.

 

[MplsGopher]

That was my frustration. There are POC systems available. Their concern is liability and media scrutiny, and probably some other items.

We can all feel your frustration, that your clients aren't getting to maximize their profits off their unapproved medical devices.

 

[MplsGopher]

duh? No one is arguing that.

and your testing would eliminate this?

and if so, I'm all for it. You're arguing with the wrong person. I agree with you that the test should be granted if it does what it says it does. Havent argued with that to date. I just have yet to see a test which has proven they do that.

I had this exact same point and he ignored it. Don't expect him to address it. Expect him to beat around the bush, because he and his clients don't want to have to prove their medical device is effective and safe. They want emergency approval to cash in on a big payday, regardless if it works.

 

[Pompous Elitist]

At this point, it should be an obvious red flag that PE is fighting so hard to remove the reporting aspect, without giving a good, logical reason why.

It would seem simply to be that, whatever maximizes his clients‘ profits is his (lobbying) job.

That just entrenches me further in, that they must not be removed.

Playing dumb again.

Alright, I’ll play your game. The reason is speed, and cost. Stopping presympomatic spread. That’s the problem. Sit down and think about it for awhile.

 

[Pompous Elitist]

duh? No one is arguing that.

and your testing would eliminate this?

and if so, I'm all for it. You're arguing with the wrong person. I agree with you that the test should be granted if it does what it says it does. Havent argued with that to date. I just have yet to see a test which has proven they do that.

Good, at least we agree on that?

Correct, it would lessen it dramatically. We won’t hear about it, just like we don’t have any idea of the actual number of current and past infections. The results will theoretically be in lower infection rates, lower hospitalizations.

Hey, I’m just passing along what the real experts are saying. It makes sense to me. It makes sense to a lot of people. There are bureaucratic roadblocks that don’t make much sense, like mandatory reporting.

 

[upnorthkid]

Good, at least we agree on that?

Correct, it would lessen it dramatically. We won’t hear about it, just like we don’t have any idea of the actual number of current and past infections. The results will theoretically be in lower infection rates, lower hospitalizations.

Hey, I’m just passing along what the real experts are saying. It makes sense to me. It makes sense to a lot of people. There are bureaucratic roadblocks that don’t make much sense, like mandatory reporting.

I don't typically get into this kind of thing, but these comments are probably a large reason why people don't like you. It comes off as being an ass and is complete anecdote. You are passing along what some experts are saying. The ones that agree with you. And that's totally cool I'm open to all opinions and want to help people. To make it an argument of my experts are better than your experts is silly. We both seem like data people and want to see data. If we get that (and replicated), I'm sure we'd both be thrilled. Your bold does nothing to help your argument.

 

[HoustonTXGopher]

Yeah. We’re starting to get to the point where, by the time some of these tests are actually, formally proven out, production ramped up, and product rolled out ... we could be getting into vaccine time anyway.

Who in their right mind would jump to be first in line for a vaccine?

 

[Pompous Elitist]

I don't typically get into this kind of thing, but these comments are probably a large reason why people don't like you. It comes off as being an ass and is complete anecdote. You are passing along what some experts are saying. The ones that agree with you. And that's totally cool I'm open to all opinions and want to help people. To make it an argument of my experts are better than your experts is silly. We both seem like data people and want to see data. If we get that (and replicated), I'm sure we'd both be thrilled. Your bold does nothing to help your argument.

It does nothing for you to near that scientists and physicians in the field are excited about this, and frustrated by regulatory hurdles? Anecdotes? You claim to be in the medical field, see what’s going on, and don’t want to explore avenues to address it?

I’ve clearly stated their test would need independent validation. You have repeatedly stated the sensitivity isn’t good enough. I said hey, don’t trust me, listen to these guys on how they address that concern. You call me the ass?

People with opinions are going to draw fire. I don’t care. And how do you know who likes me, doc? Just because you don’t, nobody else does? Do you have validated proof?

 

[MplsGopher]

Playing dumb again.

Alright, I’ll play your game. The reason is speed, and cost. Stopping presympomatic spread. That’s the problem. Sit down and think about it for awhile.

Look, we know what your clients pay you do to: lobby state governments to reduce/remove regulations for medical devices, so that they can increase profits. That's your job, fine.

Your clients want to be paid for putting a quick tester in every home in the country, whether those homes want the device next to their toasters and coffee makers, or not, and - of course - whether the device would actually help people.

That's your main drive, to make it so that regular people wouldn't have to report their results, because, again, your clients want to bypass clinics completely and go direct to people's homes.


Back in the real world, there should be no reason why reporting test results to the government is any kind of hindrance. Test results are reported to patients through things like MyChart. There should be an equivalent, electronic, non-effort way to report the same results to the government.

 

[MplsGopher]

I don't typically get into this kind of thing, but these comments are probably a large reason why people don't like you. It comes off as being an ass and is complete anecdote. You are passing along what some experts are saying. The ones that agree with you. And that's totally cool I'm open to all opinions and want to help people. To make it an argument of my experts are better than your experts is silly. We both seem like data people and want to see data. If we get that (and replicated), I'm sure we'd both be thrilled. Your bold does nothing to help your argument.

Bolded: 100% correct. That's his bit.

 

[MplsGopher]

Who in their right mind would jump to be first in line for a vaccine?

It already happened.

Tens of thousands of people signed up to trial the vaccine candidates that are ready for phase 3, and many more thousands will sign up for the next candidates.


Those are actual patriots, and people who love this country. Can you say the same thing for yourself?

 

[upnorthkid]

It does nothing for you to near that scientists and physicians in the field are excited about this, and frustrated by regulatory hurdles? Anecdotes? You claim to be in the medical field, see what’s going on, and don’t want to explore avenues to address it?

I’ve clearly stated their test would need independent validation. You have repeatedly stated the sensitivity isn’t good enough. I said hey, don’t trust me, listen to these guys on how they address that concern. You call me the ass?

People with opinions are going to draw fire. I don’t care. And how do you know who likes me, doc? Just because you don’t, nobody else does? Do you have validated proof?

You have entirely missed the point of what I was saying. Have a good day man.

 

[Pompous Elitist]

You have entirely missed the point of what I was saying. Have a good day man.

Well, explain it better then. What I read is you don’t want to listen to what experts in the field have to say, because it contradicts your opinion. Yes, they have a point of view. You have a point of view. Explain your point on “competing experts” so a ten year old understands. Why are they wrong? Do you have a competing expert? Or, pretend I’m the 80 year old with early dementia, sitting in your office.

I’ll give you a chance to apologize for flying off the handle and the insult. We’re tired and frustrated.

 

[MplsGopher]

Hopefully he doesn’t waste his time. You enjoy dragging down people with bad-faith arguments and wasting their time.

I understood what he said perfectly, and I’m not going to re-explain it to you either.

 

[HoustonTXGopher]

It already happened.

Tens of thousands of people signed up to trial the vaccine candidates that are ready for phase 3, and many more thousands will sign up for the next candidates.


Those are actual patriots, and people who love this country. Can you say the same thing for yourself?

uh, yes I can! You might want to take it down a few notches, your obnoxiousness looms throughout GH.

 

[MplsGopher]

uh, yes I can! You might want to take it down a few notches, your obnoxiousness looms throughout GH.

There are few things in life I care about less about, than how some anonymous internet posters view my own anonymous internet posts.

How can you? Military service? If so, fine. If not, very doubtful.

 

[upnorthkid]

Well, explain it better then. What I read is you don’t want to listen to what experts in the field have to say, because it contradicts your opinion. Yes, they have a point of view. You have a point of view. Explain your point on “competing experts” so a ten year old understands. Why are they wrong? Do you have a competing expert? Or, pretend I’m the 80 year old with early dementia, sitting in your office.

I’ll give you a chance to apologize for flying off the handle and the insult. We’re tired and frustrated.

I just don't get you at all. I will do this once more in effort to connect with you as something is not clear.
You have an outstanding argument and one that is sound in science but then derange into this idea that I don't agree with the premise and chase it with patronizing commentary. I don't know how many times I have to tell you that I agree with your overarching point. A rapidly available test that can increase capacity while not sacrificing sensitivity sounds fantastic. I have 2 concerns regarding the current discussion surrounding this test. 1 that the sensitivity of this test has not been externally validated and 2 (which is a substantially less important thing for the individual-which I think is more important- but is an issue for public health efforts in decision-making and recommendations at a national level) the lack of reporting mechanism in place.
On subject 1: I am all for having a rapidly available screening test that does what a screening test is supposed to do: catch as many cases of the disease as possible. This is the reason that some experts at the CDC, WHO, FDA, USPSTF, etc have noted that a screening test is helpful in a setting that it catches either 95-99% (ie HIV, EBV) of those who have the disease or (which is important in this case) is equal to the current gold standard (why FIT testing is an acceptable alternative to colonoscopy in initial screening). You have said that internally the results of this rapid screen are equivalent to the PCR. I have concern about approving a test that is not externally validated as we need to be sure that the information that will ultimately be used and acted upon by the public is similar (ie within a few percentage points) so that people are making informed decisions/reactions. If it has been externally validated and I have missed this, I am all for this test being made public and dispersed rapidly. It is better to serve individuals and deal with the population health situation later. I in no way view the opinion of Dr. Mina to be wrong and have, to the contrary, said multiple times he brings up an excellent set of points in theoretical biology and testing that I strongly agree with, which I hope has been made apparent by the above.
On subject 2: I can understand the hesitancy (not saying that I agree with how they are acting) in approving a test that will not be reported. I think you can understand the variance of viewpoint on this subject as well but fall in a different camp. I worry, and this is entirely opinion, that people will act on the test to justify lack of social distancing, etc. due to having a negative result on this, which will impact efforts being made by others to continue to do this (which is a problem pending the sensitivity of the test). However, in spite of this, if the test is proven to be equivalent to the PCR and externally validated as well as able to be mass produced/dispersed to people have access, this should not be a roadblock to this.

Regarding the comment that some view you as an ass. This is an opinion based on observation of the way people interact with you on this message board. It has nothing to do with that you disagree with people (well maybe it does for some people, I don't want to speak for Mplsgopher who clearly seems to dislike you). It has to do with your delivery of things. Speaking that you have "real" experts that agree suggests that any viewpoint to the contrary is either subjective from someone who doesn't know or that any other people are not real experts. Experts have varying opinions all the time (HCQ and Vit C in sepsis to name a couple recent ones in the medical field). Doesn't make them less of experts. It makes them human.
I personally think you add great material to this board and wonderful discourse. I know we haven't had many interactions on this board so my comment was purely that I can see why people have that viewpoint. It does come off as pompous and elitist, which is fine but can absolutely rub the wrong way particularly in the middle of making a great argument. You seem to have a great understanding of many issues and some great viewpoints, which I am open to hearing. Hopefully we will have more of this discourse on an array of subjects. Thanks.

 

[upnorthkid]

It already happened.

Tens of thousands of people signed up to trial the vaccine candidates that are ready for phase 3, and many more thousands will sign up for the next candidates.


Those are actual patriots, and people who love this country. Can you say the same thing for yourself?

chill man. seriously

 

[HoustonTXGopher]

There are few things in life I care about less about, than how some anonymous internet posters view my own anonymous internet posts.

How can you? Military service? If so, fine. If not, very doubtful.

So, if I didn't serve in the military, I hate this country? If I did serve in the military, I love this country?