Coronavirus: What questions do you have?

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speed

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The CDC information is not incorrect, you just don't know what you are talking about and you posted a link to a stop use order about an antigen test (not a PCR test)

And, since you asked, yes I'm a molecular biologist with a PhD, 13 years experience supporting molecular test development and the last 13 years of my life have been supporting clinical trials (both testing and clinical development).

The link you shared was a directive to stop using a specific rapid test from a company called Innova. This is an ANTIGEN test, meaning it looks for specific bits of virus protein. Apparently the FDA doesn't think the data from the manufacturer supports the use claimed by Innova. This has nothing whatsoever to do with PCR testing.

The link you probably should have posted is this one:


While good fodder for conspiracy theories, the fact is there's no need for testing under EUA given the number of fully approved tests on the market. This is all explained in the CDC link I posted above. There are a number of molecular diagnostic tests (PCR and related) and serology based ones (testing blood). Go to the site. Learn. Turn off the conspiracy theory channels.

Here's a fact-check of the whole issue. The loonies are coming out of the woodwork with this.

Something from the cdc instead of a "fact checker" would be more helpful...
 

Marc_G

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Something from the cdc instead of a "fact checker" would be more helpful...
I gave you the link to the official CDC announcement... read it. But, here is the text from that site, with comments from me in bold italics:

Audience: Individuals Performing COVID-19 Testing (this means labs should pay attention to this and conspiracy theorists need not dwell on it)


Level
: Laboratory Alert


After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives. (this means labs that are NOT using a fully approved test [PCR or otherwise] need to plan to switch to one of the fully approved tests [PCR or otherwise]... the EUA provided a year and a half ago let labs do testing using home brew fit for purpose tests prior to full FDA review and approval of these, but meanwhile many of these tests are now fully approved and commercially available, so labs need to plan to purchase fully approved tests if they are not already doing so)


Visit the FDA website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page. (this is a list that helps labs decide which test to buy, that is already fully approved, if they are not doing so already)


In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing. (this means that many commercially available tests can do multiple tests in a single sample, informing the patients as to whether they have covid, flu, both, or neither... these tests are highly specific and they do not mix things up or report flu as covid)

Here, for example, is a home based test you can order to check for the same stuff... it will tell you if you have COVID, Flu, neither, or both...


 

Peartree

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I gave you the link to the official CDC announcement... read it. But, here is the text from that site, with comments from me in bold italics:

Audience: Individuals Performing COVID-19 Testing (this means labs should pay attention to this and conspiracy theorists need not dwell on it)


Level
: Laboratory Alert


After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives. (this means labs that are NOT using a fully approved test [PCR or otherwise] need to plan to switch to one of the fully approved tests [PCR or otherwise]... the EUA provided a year and a half ago let labs do testing using home brew fit for purpose tests prior to full FDA review and approval of these, but meanwhile many of these tests are now fully approved and commercially available, so labs need to plan to purchase fully approved tests if they are not already doing so)


Visit the FDA website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page. (this is a list that helps labs decide which test to buy, that is already fully approved, if they are not doing so already)


In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing. (this means that many commercially available tests can do multiple tests in a single sample, informing the patients as to whether they have covid, flu, both, or neither... these tests are highly specific and they do not mix things up or report flu as covid)

Here, for example, is a home based test you can order to check for the same stuff... it will tell you if you have COVID, Flu, neither, or both...


Thank you. This is really the explanation that I was looking for. It was obvious that there were a LOT of approved tests, that the EUA would continue until the end of the year (so it wasn't anything terrible that was being stopped) but I was a little fuzzy on what it all finally meant in plain English. This helps. Again, thanks.
 

Marc_G

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And, just as a clarification, I posted a link to the Labcorp home test because it was the first link I found to a test that detects and reports multiple things (Covid and flu strains)... But there are similar commercial tests for labs to run, that are fully FDA approved.
 

speed

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I gave you the link to the official CDC announcement... read it. But, here is the text from that site, with comments from me in bold italics:

Audience: Individuals Performing COVID-19 Testing (this means labs should pay attention to this and conspiracy theorists need not dwell on it)


Level
: Laboratory Alert


After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives. (this means labs that are NOT using a fully approved test [PCR or otherwise] need to plan to switch to one of the fully approved tests [PCR or otherwise]... the EUA provided a year and a half ago let labs do testing using home brew fit for purpose tests prior to full FDA review and approval of these, but meanwhile many of these tests are now fully approved and commercially available, so labs need to plan to purchase fully approved tests if they are not already doing so)


Visit the FDA website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page. (this is a list that helps labs decide which test to buy, that is already fully approved, if they are not doing so already)


In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing. (this means that many commercially available tests can do multiple tests in a single sample, informing the patients as to whether they have covid, flu, both, or neither... these tests are highly specific and they do not mix things up or report flu as covid)

Here, for example, is a home based test you can order to check for the same stuff... it will tell you if you have COVID, Flu, neither, or both...


Has this test{CDC 2019-nCoV RT-PCR } ever resulted in false positives? Or test positive for the influenza virus?
 

boatgeek

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Has this test{CDC 2019-nCoV RT-PCR } ever resulted in false positives? Or test positive for the influenza virus?
Dude, every test has false positives, just like every test has false negatives. We hope that there aren't very many of either kind, but there are always a few. That doesn't mean that the whole system is wrong or that the pandemic never happened, just that nothing is perfect.
 

dhbarr

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Has this test{CDC 2019-nCoV RT-PCR } ever resulted in false positives? Or test positive for the influenza virus?
This is a loaded question, because it presupposes that the number of true and false positives and negatives can be known by this forum.

You make a claim, you provide the evidence. If you're claiming this test has resulted in such, point to the study demonstrating same.

One doesn't get to demand facts opposing a hypothesis when they themselves have offered nothing falsifiable.
 

Marc_G

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Has this test{CDC 2019-nCoV RT-PCR } ever resulted in false positives? Or test positive for the influenza virus?
The test in question, the original Covid RT-PCR test, was extensively tested for cross reactivity against flu and other common things present in the population prior to adoption. Each successive generation of molecular testing has had more testing than the ones before them. The big companies doing most of the commercial testing (Quest, LabCorp for example) switched to their own versions of tests a while back, which are fully FDA approved and very well documented. The suspension of the EUA is mostly a cautionary note to smaller operations still mixing up their own cocktails that it is time to adjust their operations and SOPs to use a commercial product.
 

ksaves2

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Shoot,

It's fun to watch you real smart folks argue an issue. I understand a bit of it which makes it that much "funner".

Kurt Savegnago M.D. (retired and did a 5 and a half year residency after med school so not completely ignorant)
 

cwbullet

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Today was a rough day. We are consistently testing more and more and now 20% positive sustained. 25% of those are vaccinated. I have a young patient admitted and intubated with no risks. It is a good time for prayer in whatever you believe.
 
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3stoogesrocketry

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As of yesterday , if you want to continue collecting military VA benefits , you must be vaccinated.
All NY state employees must be vaccinated or they have to get tested once per week.
Soon , you will not have a choice in this free country .
 

Marc_G

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Chuck, question: is there any research Covid does/does not get transmitted by mosquitoes, a la Zika and other diseases.

I'm on vacation in a relatively low vax state, and have been mobbed by mosquitoes!
 

Marc_G

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As of yesterday , if you want to continue collecting military VA benefits , you must be vaccinated.
All NY state employees must be vaccinated or they have to get tested once per week.
Soon , you will not have a choice in this free country .
Look guys, think of the vaccination as being similar to the military draft. Lots of folks didn't want to go fight a war they either didn't understand, with tech they may never have experienced before, often for purposes they may have disagreed with. But they strapped on their boots and did their duty to protect us and we called them the greatest generation for it.

One and a half times as many US folks have died due to COVID as military personnel died in WW2.

Do your duty.

Chuck, thank you for putting yourself voluntarily in harm's way as a military man, a doctor, and your efforts re: Covid.
 

BABAR

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Today was a rough day. We are consistently testing more and more and now 20% positive sustained. 25% of those are vaccinated. I have a young patient admitted and intubated with no risks. It is a good time for prayer in what every you believe.
This may be a tough question to answer, because less sick patients may never even present for testing, but what the heck. In general, when vaccinated patients get Delta or some other variant, are they more sick, less sick, or similarly sick compared to the same variant in the unvaccinated patients?
 

cwbullet

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Chuck, question: is there any research Covid does/does not get transmitted by mosquitoes, a la Zika and other diseases.

I'm on vacation in a relatively low vax state, and have been mobbed by mosquitoes!
No evidence has been found to support tick, insect, or mosquito passage. It has been looked at without any positive findings.
 

cwbullet

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Today has been a rough day. We have had a huge jump in infections and I am working the testing operation. I screened and tested over 200 per day each fo the last two days. There are a lot of sick folks and most are not covid. I have been running other viral panels and we are seeing a lot of RSV, Adenovirus, and Strep. Only 1/4-1/3 is COVID.

Can we please go back to wearing masks.
 

Cl(VII)

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This may be a tough question to answer, because less sick patients may never even present for testing, but what the heck. In general, when vaccinated patients get Delta or some other variant, are they more sick, less sick, or similarly sick compared to the same variant in the unvaccinated patients?
Small "n" data, but I personally know three breakthrough cases. All three said they would have thought they had bad allergies except for the loss of taste and smell. They were each free of symptoms, except for the taste and smell thing, within 5 days.
 

kuririn

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As of yesterday , if you want to continue collecting military VA benefits , you must be vaccinated.
All NY state employees must be vaccinated or they have to get tested once per week.
Soon , you will not have a choice in this free country .
If you're referring to the announcement the other day from the VA, it refers to vaccination of their health care employees, not beneficiaries.
 

mo2872

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Today has been a rough day. We have had a huge jump in infections and I am working the testing operation. I screened and tested over 200 per day each fo the last two days. There are a lot of sick folks and most are not covid. I have been running other viral panels and we are seeing a lot of RSV, Adenovirus, and Strep. Only 1/4-1/3 is COVID.

Can we please go back to wearing masks.
My 15 year old(vaxxed) just had strep last week. I told him we were still allowed to be "normal" sick.

Edited to add a query: they didn't even bother testing for Covid. Is this becoming SOP? His only symptom was a raw throat, and we were fairly certain it was going to be strep, but would have thought a WuHu test would be standard anymore.
 
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PatD

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No, you conveniently neglected to include the rest of the CDC statement in your excerpt.

"In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing."

In other words they are encouraging labs to use multiplexed tests that can detect both flu and Covid and save time and money, not saying that the tests mistake one for the other.


This is a recommendation on one test. There are many others. The recommendation is because the others came out later and are multiplexed allowing for testing of both viruses.
And by the way, it's PCR, not PRC.
Freudian slip, PRC = Peoples Republic of China vs polymerase chain reaction (PCR) test. 🤣
 

NateB

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Edited to add a query: they didn't even bother testing for Covid. Is this becoming SOP? His only symptom was a raw throat,
Good question, I'm curious too.

Some hospitals we go to seem to give a Covid test to everyone in the ED, or at least everyone that is getting transferred out for a higher level of care. I've seen several cases which were clearly something else and still found a Covid screen or they made sure to tell us the results as we walked in.

I've also seen patients from other hospitals where the tests weren't done or at least weren't done yet and wouldn't seem likely to be indicated. I'd be curious to know different policies for different states or hospital systems.
 

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My 15 year old(vaxxed) just had strep last week. I told him we were still allowed to be "normal" sick.

Edited to add a query: they didn't even bother testing for Covid. Is this becoming SOP? His only symptom was a raw throat, and we were fairly certain it was going to be strep, but would have thought a WuHu test would be standard anymore.
No. It is not SOP to not text for COVID, but it is a clinical judgement based on presentation. A strep test is probably less than $30 and a COVID PCR test is 150-300. I will not order a COVID test if I am certain it is strep. I am pretty darn good at determining something is likely strep with the right questions and an exam.
 

cwbullet

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President Biden is reportedly going to mandate, today, that all federal employees receive the vaccine or be tested weekly.
:popcorn::popcorn::popcorn::popcorn::popcorn:
I will be watching this one. I am a fan of personal liberty, but it is time that we do something to end this pandemic but I am not sure that "something" is. This may send some federal employees to the unemployment lines.

Please try to keep the posts to questions with no political comments.
 

dhbarr

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President Biden is reportedly going to mandate, today, that all federal employees receive the vaccine or be tested weekly.
:popcorn::popcorn::popcorn::popcorn::popcorn:
I will be watching this one. I am a fan of personal liberty, but it is time that we do something to end this pandemic but I am not sure that "something" is. This may send some federal employees to the unemployment lines.

Please try to keep the posts to questions with no political comments.
My employer also announced proof-of-vax for returning to office. Mildly amusing to me since a) I've been jabbed since March and b) I've been going to work everyday anyway.

EDIT: And my choice of either long quarantine or test-with-short-quarantine whenever I travel outside the metro or have possible exposure.
 
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NOLA_BAR

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My employer also announced proof-of-vax for returning to office. Mildly amusing to me since a) I've been jabbed since March and b) I've been going to work everyday anyway.
My employer is now requiring all employees to be vaccinated. The latest incident was a non-vaxxed employee getting COVID and exposing several others in the office. It is too much of a disruption and too many people out for days or week or more. Basically provide proof of vaccination by July 31 or resign. The best I could figure it was 80/20 vaccinated versus non-vaccinated. The company pretty much decided the non-vaccinated represented a health and safety issue for the rest of the employees.
 

Marc_G

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I think the tipping point has been reached. Given Delta variant has an R value in the 5-8 range, it's going to be hard to clamp down by fully voluntary measures. Also given that the vaxxed can get infected, albeit with less dire consequences, it's time for stronger approaches.

I work remotely for now but would not consider a return to office unless it was vax required.
 

Bill S

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That'll be interesting for my brother in law and his wife, both of whom work for Social Security, and have been working from home since this whole thing started. They aren't allowed to come in; the entire building has been closed since the pandemic started. Given that they hate the current admin, and still haven't been vaccinated yet, it'll be interesting to see if they find other work or suck it up. They are both hugely obese and in terrible physical condition, they really should get vaccinated but haven't.
 
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