It's just the flu!
04-20-2020 | 11:04 PM
#121
Bracing for Fallacies
Joined: Jul 2007
Posts: 3,543
Likes: 0
From: In favor of good things, not in favor of bad things
SARS-CoV-2 is killing people around the globe - novel viruses have a way of doing that - but it is not a global society killer and at this point shouldn’t continue to be treated as such.
Does that mean we discount the very real clinical and medical impacts it has on people? NO, it means you identify the most at risk and work to protect them, fully understanding there will be some outside that group that experience severe disease and die. In that sense, it is similar to influenza. We also must continue working to provide front-line health workers with proper PPE, and build sizable stockpiles at the hospital up to national level.
Does that mean we flip the switch and end all restrictions? NO, clearly social distancing has served its intended purpose of not overwhelming health systems across the nation. Maintaining those restrictions until zero new infections or a vaccine is unrealistic, but the proposed phased relaxation based upon infection trends seems a prudent balancing of public health and economic concerns. Testing capability is increasing weekly and surveillance will be necessary to identify and tamp down any future local waves of infection.
Today, we have no idea what actual mortality of this thing is. CFR is 5%+ in many countries, even the USA, but multiple antibody studies from around the globe so far estimate actual mortality between 0.1 and 0.5%. Again, does that negate the real clinical impacts this has on some people? NO! What it does do, however, is better inform public policies and individual actions...
Does that mean we discount the very real clinical and medical impacts it has on people? NO, it means you identify the most at risk and work to protect them, fully understanding there will be some outside that group that experience severe disease and die. In that sense, it is similar to influenza. We also must continue working to provide front-line health workers with proper PPE, and build sizable stockpiles at the hospital up to national level.
Does that mean we flip the switch and end all restrictions? NO, clearly social distancing has served its intended purpose of not overwhelming health systems across the nation. Maintaining those restrictions until zero new infections or a vaccine is unrealistic, but the proposed phased relaxation based upon infection trends seems a prudent balancing of public health and economic concerns. Testing capability is increasing weekly and surveillance will be necessary to identify and tamp down any future local waves of infection.
Today, we have no idea what actual mortality of this thing is. CFR is 5%+ in many countries, even the USA, but multiple antibody studies from around the globe so far estimate actual mortality between 0.1 and 0.5%. Again, does that negate the real clinical impacts this has on some people? NO! What it does do, however, is better inform public policies and individual actions...
1. COVID requires a serious response while....
2. A one size fits all solution is not necessary as we move forward with our society, thus minimizing economic and associated harm.
04-21-2020 | 03:27 AM
#122
Line Holder
Joined: Nov 2017
Posts: 62
Likes: 0
From: Director of Operations
The way the reports keep rolling in and rolling in about the interesting manner in which deaths are recorded, that the survival rates are very high while the number of infected may be even higher than forecast (resulting in yet lower death rates still)....yeah, I'd be careful about loosely dropping "idiots" on people who disagree with you.
https://www1.nyc.gov/assets/doh/down...04202020-1.pdf
Their main data page is awesome.
https://www1.nyc.gov/site/doh/covid/covid-19-data.page
04-21-2020 | 05:06 AM
#123
Gets Weekends Off
Joined: Sep 2015
Posts: 1,034
Likes: 2
From: I got into this business so I wouldn't have to work.
By WutFace
04-21-2020 | 05:34 AM
#124
Doing One Pilot's Job
Joined: Sep 2005
Posts: 7,884
Likes: 119
So far there have been antibody studies published from the following areas:
LA County, CA
Santa Clara County, California
Boston/Chelsea, MA
Gangelt, Germany
Capitol Region, Denmark
There likely have been more that I'm not aware of.
They've all essentially come to similar conclusions about prevalence of previous SARS-CoV-2 infection, if seeing different rates of previous infection in a given location.
There are questions about the accuracy of antibody tests used, as well as methodologies used, small cohorts sampled, and lack of peer review to this point. Those are scientifically fair questions to ask, but what are the odds that five independent research teams from three different countries on two different continents checking five different population groups would ALL utilize the same (potentially) flawed tests and methodologies? Possible...but does not seem very scientifically probable.
One study is not actionable for policy, but at least five reporting similar results shows a trend. As more antibody studies are released in the coming weeks, we will see if those regional and local results align or differ from what has already been released.
Is all that "anecdotal"? Yes, I suppose so...but if you hear similar anecdotes from multiple different people in multiple different places, should they be dismissed simply due to a lack of peer review in the midst of crisis?
LA County, CA
Santa Clara County, California
Boston/Chelsea, MA
Gangelt, Germany
Capitol Region, Denmark
There likely have been more that I'm not aware of.
They've all essentially come to similar conclusions about prevalence of previous SARS-CoV-2 infection, if seeing different rates of previous infection in a given location.
There are questions about the accuracy of antibody tests used, as well as methodologies used, small cohorts sampled, and lack of peer review to this point. Those are scientifically fair questions to ask, but what are the odds that five independent research teams from three different countries on two different continents checking five different population groups would ALL utilize the same (potentially) flawed tests and methodologies? Possible...but does not seem very scientifically probable.
One study is not actionable for policy, but at least five reporting similar results shows a trend. As more antibody studies are released in the coming weeks, we will see if those regional and local results align or differ from what has already been released.
Is all that "anecdotal"? Yes, I suppose so...but if you hear similar anecdotes from multiple different people in multiple different places, should they be dismissed simply due to a lack of peer review in the midst of crisis?
04-21-2020 | 06:54 AM
#125
Custom User Title
Joined: Feb 2007
Posts: 2,274
Likes: 0
I put this together today to see what it looks at the state level when comparing flu deaths to COVID 19 deaths. Flu deaths used are for the 2018 season from the CDC website. COVID 19 deaths are through today April 21 via Statista.com. 44 states have yet to have their COVID-19 deaths equal last years flu deaths, with most of them not even close to matching their flu deaths. Only six states have had their COVID-19 deaths exceed last years flu deaths, with NY and NJ being significant outliers among that group. I'm not offering any opinions on what you should do with this information. Decide for yourself what it means.
04-21-2020 | 07:06 AM
#126
Perennial Reserve
Joined: Jan 2018
Posts: 14,194
Likes: 240
Indeed. Even us “idiots” know that even just doing the antibody testing must be approved - like all human research - by a human utilization review panel or institutional review board of subject matter experts who validate the scientific validity and potential benefit of the research being done. Even for just grabbing a few thousand samples of blood.
04-21-2020 | 07:19 AM
#127
Gets Weekends Off
Joined: Oct 2018
Posts: 564
Likes: 0
I'll chime in on this.
I'm very familiar with one of the four antibody tests currently being performed and approved under FDA emergency authorization. I am also familiar with the the other 3, but not as well.
Any test method has to be accurate, precise, robust, linear, sensative and specific.
accuracy... as it sounds, if your result should be 90, the closer to 90 the better.
Precision.. how close to the bullseye you get in multiple attempts. This used to be called reliability and is measured by r2.
Robustness... having reliable and accurate results on different days, different personnel, different laboratories/clinical settings, different instruments/equipment, reagents etc. This is used to reduce the chance of bias. "On sunny days good results, rainy days, bad results"
Linearity... evaluate the response of the test to ensure a little amount produces a little result and a large amount of analyte has a proportional large result.
Sensitivity... determine the methods detection limit and also the level the method can reliability produce an accurate, precise and linear result.
Specificity.. determine if the method selectivity only analyzes what you want. Is the method prone to interference from other analytes? This was once called selectivity.
Under the emergency authorization by the FDA some of these studies were very abbreviated and developed and validated by groups (universities) that commonly don't validate these tests.
Antibody tests are looking for immunoglobulins, specifically IgG and IgM. In order for the test to be selective for COVID19, a way to seperate the COVID19 antibodies from the gagillion of other antibodies and other proteins floating around in a patients blood. So a synthetic antigen is made with the hope of teasing the immunoglobulin out. This is the tricky part as the COVID19s spike protien is unique, it's not completely novel and people have similar antibodies, though not COVID19 antibodies that may or may not conjugate with the antigen. Also for some reason, genetics, compromised immune system, people's antibodies, although present just don't bind with the antigen. The tests build that fudge factor in, but that's a guess based on other immuno assays.
The degree of error of the tests haven't been determined yet. A guess of error has been made, up to 60% for one said test, but many of these leaked studies are actually the clinical trail and data aggregation of the test itself.
What I'm saying is don't get too caught up in the news and numbers yet. We still have a lot of science to do and science takes time as frustrating as it is.
I worked on a monoclonal antibody a way back. We thought it was going to change the world, and our data looked great and in a controlled clinical setting the therapy outperformed all expectations. Several months after approval, adverse events and deaths piled up. A recall was initiated and a year later we finally figured out what we missed. Science takes time.
I'm very familiar with one of the four antibody tests currently being performed and approved under FDA emergency authorization. I am also familiar with the the other 3, but not as well.
Any test method has to be accurate, precise, robust, linear, sensative and specific.
accuracy... as it sounds, if your result should be 90, the closer to 90 the better.
Precision.. how close to the bullseye you get in multiple attempts. This used to be called reliability and is measured by r2.
Robustness... having reliable and accurate results on different days, different personnel, different laboratories/clinical settings, different instruments/equipment, reagents etc. This is used to reduce the chance of bias. "On sunny days good results, rainy days, bad results"
Linearity... evaluate the response of the test to ensure a little amount produces a little result and a large amount of analyte has a proportional large result.
Sensitivity... determine the methods detection limit and also the level the method can reliability produce an accurate, precise and linear result.
Specificity.. determine if the method selectivity only analyzes what you want. Is the method prone to interference from other analytes? This was once called selectivity.
Under the emergency authorization by the FDA some of these studies were very abbreviated and developed and validated by groups (universities) that commonly don't validate these tests.
Antibody tests are looking for immunoglobulins, specifically IgG and IgM. In order for the test to be selective for COVID19, a way to seperate the COVID19 antibodies from the gagillion of other antibodies and other proteins floating around in a patients blood. So a synthetic antigen is made with the hope of teasing the immunoglobulin out. This is the tricky part as the COVID19s spike protien is unique, it's not completely novel and people have similar antibodies, though not COVID19 antibodies that may or may not conjugate with the antigen. Also for some reason, genetics, compromised immune system, people's antibodies, although present just don't bind with the antigen. The tests build that fudge factor in, but that's a guess based on other immuno assays.
The degree of error of the tests haven't been determined yet. A guess of error has been made, up to 60% for one said test, but many of these leaked studies are actually the clinical trail and data aggregation of the test itself.
What I'm saying is don't get too caught up in the news and numbers yet. We still have a lot of science to do and science takes time as frustrating as it is.
I worked on a monoclonal antibody a way back. We thought it was going to change the world, and our data looked great and in a controlled clinical setting the therapy outperformed all expectations. Several months after approval, adverse events and deaths piled up. A recall was initiated and a year later we finally figured out what we missed. Science takes time.
04-21-2020 | 07:34 AM
#128
Perennial Reserve
Joined: Jan 2018
Posts: 14,194
Likes: 240
I'll chime in on this.
I'm very familiar with one of the four antibody tests currently being performed and approved under FDA emergency authorization. I am also familiar with the the other 3, but not as well.
Any test method has to be accurate, precise, robust, linear, sensative and specific.
accuracy... as it sounds, if your result should be 90, the closer to 90 the better.
Precision.. how close to the bullseye you get in multiple attempts. This used to be called reliability and is measured by r2.
Robustness... having reliable and accurate results on different days, different personnel, different laboratories/clinical settings, different instruments/equipment, reagents etc. This is used to reduce the chance of bias. "On sunny days good results, rainy days, bad results"
Linearity... evaluate the response of the test to ensure a little amount produces a little result and a large amount of analyte has a proportional large result.
Sensitivity... determine the methods detection limit and also the level the method can reliability produce an accurate, precise and linear result.
Specificity.. determine if the method selectivity only analyzes what you want. Is the method prone to interference from other analytes? This was once called selectivity.
Under the emergency authorization by the FDA some of these studies were very abbreviated and developed and validated by groups (universities) that commonly don't validate these tests.
Antibody tests are looking for immunoglobulins, specifically IgG and IgM. In order for the test to be selective for COVID19, a way to seperate the COVID19 antibodies from the gagillion of other antibodies and other proteins floating around in a patients blood. So a synthetic antigen is made with the hope of teasing the immunoglobulin out. This is the tricky part as the COVID19s spike protien is unique, it's not completely novel and people have similar antibodies, though not COVID19 antibodies that may or may not conjugate with the antigen. Also for some reason, genetics, compromised immune system, people's antibodies, although present just don't bind with the antigen. The tests build that fudge factor in, but that's a guess based on other immuno assays.
The degree of error of the tests haven't been determined yet. A guess of error has been made, up to 60% for one said test, but many of these leaked studies are actually the clinical trail and data aggregation of the test itself.
What I'm saying is don't get too caught up in the news and numbers yet. We still have a lot of science to do and science takes time as frustrating as it is.
I worked on a monoclonal antibody a way back. We thought it was going to change the world, and our data looked great and in a controlled clinical setting the therapy outperformed all expectations. Several months after approval, adverse events and deaths piled up. A recall was initiated and a year later we finally figured out what we missed. Science takes time.
I'm very familiar with one of the four antibody tests currently being performed and approved under FDA emergency authorization. I am also familiar with the the other 3, but not as well.
Any test method has to be accurate, precise, robust, linear, sensative and specific.
accuracy... as it sounds, if your result should be 90, the closer to 90 the better.
Precision.. how close to the bullseye you get in multiple attempts. This used to be called reliability and is measured by r2.
Robustness... having reliable and accurate results on different days, different personnel, different laboratories/clinical settings, different instruments/equipment, reagents etc. This is used to reduce the chance of bias. "On sunny days good results, rainy days, bad results"
Linearity... evaluate the response of the test to ensure a little amount produces a little result and a large amount of analyte has a proportional large result.
Sensitivity... determine the methods detection limit and also the level the method can reliability produce an accurate, precise and linear result.
Specificity.. determine if the method selectivity only analyzes what you want. Is the method prone to interference from other analytes? This was once called selectivity.
Under the emergency authorization by the FDA some of these studies were very abbreviated and developed and validated by groups (universities) that commonly don't validate these tests.
Antibody tests are looking for immunoglobulins, specifically IgG and IgM. In order for the test to be selective for COVID19, a way to seperate the COVID19 antibodies from the gagillion of other antibodies and other proteins floating around in a patients blood. So a synthetic antigen is made with the hope of teasing the immunoglobulin out. This is the tricky part as the COVID19s spike protien is unique, it's not completely novel and people have similar antibodies, though not COVID19 antibodies that may or may not conjugate with the antigen. Also for some reason, genetics, compromised immune system, people's antibodies, although present just don't bind with the antigen. The tests build that fudge factor in, but that's a guess based on other immuno assays.
The degree of error of the tests haven't been determined yet. A guess of error has been made, up to 60% for one said test, but many of these leaked studies are actually the clinical trail and data aggregation of the test itself.
What I'm saying is don't get too caught up in the news and numbers yet. We still have a lot of science to do and science takes time as frustrating as it is.
I worked on a monoclonal antibody a way back. We thought it was going to change the world, and our data looked great and in a controlled clinical setting the therapy outperformed all expectations. Several months after approval, adverse events and deaths piled up. A recall was initiated and a year later we finally figured out what we missed. Science takes time.
The alternative currently is testing for viral particle fragments. It is a test that was fielded and mass produced with great difficulty over a few months. Initial batches of tests had to be recalled because contamination of one of the reagents by the control positive material, giving positive tests even with control blanks. Other tests from overseas sources (mostly China) were returned by the U.K. and Iran because they simply did not work.
when it DOES work it works only on the covid-19 in a narrow timeframe of the illness. Test too soon - it’s negative. Test too late - it is again negative. We KNOW it has a low predictive value positive AND negative in actual practice.
04-21-2020 | 08:26 AM
#129
Gets Weekends Off
Joined: Oct 2018
Posts: 564
Likes: 0
That’s all well and good but as the man said, “Don’t compare me to the almighty, compare me to the alternative.”
The alternative currently is testing for viral particle fragments. It is a test that was fielded and mass produced with great difficulty over a few months. Initial batches of tests had to be recalled because contamination of one of the reagents by the control positive material, giving positive tests even with control blanks. Other tests from overseas sources (mostly China) were returned by the U.K. and Iran because they simply did not work.
when it DOES work it works only on the covid-19 in a narrow timeframe of the illness. Test too soon - it’s negative. Test too late - it is again negative. We KNOW it has a low predictive value positive AND negative in actual practice.
The alternative currently is testing for viral particle fragments. It is a test that was fielded and mass produced with great difficulty over a few months. Initial batches of tests had to be recalled because contamination of one of the reagents by the control positive material, giving positive tests even with control blanks. Other tests from overseas sources (mostly China) were returned by the U.K. and Iran because they simply did not work.
when it DOES work it works only on the covid-19 in a narrow timeframe of the illness. Test too soon - it’s negative. Test too late - it is again negative. We KNOW it has a low predictive value positive AND negative in actual practice.
The current rapid PCR test is still cumbersome. I have 1000s of hours driving a PCR. The whole contaminated reagent thing... fancy news to say... in reality, the USA is a fragmented system of clinical labs, small and large, some universities and the CDC which is actually not that large and is a research agency not a large scale clinical testing facility. Unfortunately there was no guidance in the beginning on who is to do what and the CDC was forced to produce a commercial test kit, something it never does with a relatively small staff. They were literally doing this by hand sitting around as a team on lab benches trying to make 1000s of "test kits".
Next thing you know you have all hands on deck in a the CDC labs acting as a clinical supplies manufacture, something they never do.
04-21-2020 | 09:46 AM
#130
Perennial Reserve
Joined: Jan 2018
Posts: 14,194
Likes: 240
That's the usual with viral replicant test. In the early days of HIV we didn't test for the virus we tested for the antibodies. We still do but now able to test for viral load. Now HIV patients are classified as undetected with treatment, yet the virus may still be present and without treatment may/ will be detectable again.
The current rapid PCR test is still cumbersome. I have 1000s of hours driving a PCR. The whole contaminated reagent thing... fancy news to say... in reality, the USA is a fragmented system of clinical labs, small and large, some universities and the CDC which is actually not that large and is a research agency not a large scale clinical testing facility. Unfortunately there was no guidance in the beginning on who is to do what and the CDC was forced to produce a commercial test kit, something it never does with a relatively small staff. They were literally doing this by hand sitting around as a team on lab benches trying to make 1000s of "test kits".
Next thing you know you have all hands on deck in a the CDC labs acting as a clinical supplies manufacture, something they never do.
The current rapid PCR test is still cumbersome. I have 1000s of hours driving a PCR. The whole contaminated reagent thing... fancy news to say... in reality, the USA is a fragmented system of clinical labs, small and large, some universities and the CDC which is actually not that large and is a research agency not a large scale clinical testing facility. Unfortunately there was no guidance in the beginning on who is to do what and the CDC was forced to produce a commercial test kit, something it never does with a relatively small staff. They were literally doing this by hand sitting around as a team on lab benches trying to make 1000s of "test kits".
Next thing you know you have all hands on deck in a the CDC labs acting as a clinical supplies manufacture, something they never do.
Which doesn’t change the reality. The current PCR tests available are a POS test that was too rapidly developed and too quickly fielded to be reliable, under the same sort of waivers given to the antibody testing, but that’s just part of the problem. Even when they do work they have a low predictive value positive and a low predictive value negative. But even if that could be fixed you have no fix for the fact that they are applicable at all for only a short window of detection. OF COURSE they are going to miss a lot of cases.
And yes, the antibody tests were produced under the same sort of FDA emergency waivers but that’s just it, these tests were produced under THE SAME FDA waivers which gives you no rationale for believing the PCR is any more accurate than the antibody tests and considerable theoretical evidence (not to mention the simple application of Baye’s Theorem) to suggest their predictive value positive AND negative is likely to be BETTER than the PCR testing results.
And I don’t get your “viral load” comparison with HIV testing. I’m unaware of any indication of great numbers of people being chronically infected with coronavirus and whether or not those individuals will be effective transmitters of coronavirus even if they exist.
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