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Study shows that PCR tests with 35 cycles or more have an accuracy below 3%, meaning up to 97% of positive results could be false positives.

cman

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Source please, I would love to see that. Maybe they changed it too;)
I would expecially be interested to compare with the new language from the WHO to see if we are talking about the same thing:

"Users of IVDs must read and follow the IFU carefully to determine if manual adjustment of the PCR positivity threshold is recommended by the manufacturer.
WHO guidance Diagnostic testing for SARS-CoV-2 states that careful interpretation of weak positive results is needed (1). The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load. Where test results do not correspond with the clinical presentation, a new specimen should be taken and retested using the same or different NAT technology."
The EUA's issued for these tests by the FDA have most of these same requirements in addition to many more.

Authorized laboratories using your product will use your product as outlined in the Instructions for Use. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.

Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

 

DannyTS

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The EUA's issued for these tests by the FDA have most of these same requirements in addition to many more.

Authorized laboratories using your product will use your product as outlined in the Instructions for Use. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.

Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

We are obviously not talking about the same thing. I do not see any reference about the number of cycles and the inverse correlation with the patient's viral load which is the issue at the core of the thread and the comment you are referring to.
Thank you for pointing out the lack of reference to the number of cycles, we will use it as a data point in case FDA does change it. Again, this is from WHO and it appears to be very different from what you quoted:
"The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load. Where test results do not correspond with the clinical presentation, a new specimen should be taken and retested using the same or different NAT technology."
 
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cman

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I do not see any reference about the number of cycles and the inverse correlation with the patient's viral load which is the issue at the core of the thread and the comment you are referring to.

You're not looking in the right place. The reference to the number of cycles is in the section of the IFU that defines how the results should be interpreted. You can access the IFU's using the link I provided earlier. Just select "IFU" on the right hand side and read away.

"The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load."
WHO is just stating the obvious here. All they're saying is that the fewer cycles needed for detection, the higher the viral load. That's just a function of how these tests work.

I'm not sure about is the recommendation to retest if results are not consistent with clinical observations. The NIH issues clinical guidelines but I'm not sure if they've put out anything on this.
 
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DannyTS

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You're not looking in the right place. The reference to the number of cycles is in the section of the IFU that defines how the results should be interpreted. You can access the IFU's using the link I provided earlier. Just select "IFU" on the right hand side and read away.


WHO is just stating the obvious here. All they're saying is that the fewer cycles needed for detection, the higher the viral load. That's just a function of how these tests work.

The only thing in the WHO statement I'm not sure about is the recommendation to retest if results are not consistent with clinical observations. The NIH issues clinical guidelines but I'm not sure if they've put out anything on this.
Why don't you give us the exact quote that refers to the number of amplifications on either the CDC or the FDA sites? I gave you the one from WHO that is brand new! Either way, we shall see what happens in the following weeks.

I am glad you are now saying it is obvious that the number of amplifications is inverse proportional with the viral load. Let's remember all why it is important:

1611425991407.png

 
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I am glad you are now saying it is obvious that the number of amplifications is inverse proportional with the viral load. Let's remember all why it is important:

Not sure what you mean by "now". The implication that I've previously said anything to the contrary is another example of @DannyTS just making things up.

Have a good day my friend and go easy on using those "alternative facts".
 

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Not sure what you mean by "now". The implication that I've previously said anything to the contrary is another example of @DannyTS just making things up.

Have a good day my friend and go easy on using those "alternative facts".

It is more important to emphasize that 5 months after the article was published, there seems to be an acknowledgment from an official medical body that may bring some significant changes. It is more important to follow up on this in few weeks than to debate the meaning of "now".

I started this thread two months ago and you have had several contributions, I don't remember you ever being supportive of the idea that a high number of amplifications can lead to an artificially high number of positives (as stated by the NYT). It is such a central point of the thread that, since you only made the statement today in a 2 months old thread I can accurately write that "now" you said it. But prove me wrong, if you have ever written about the correlation I am ready to have a look. Until I see that, today is indeed "now". It seems your fact checking machine still bust?


Have a fabulous day.
 
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Conan

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Meanwhile, pertinent to the question of whether covid-19 is responsible for the measurable increase in American deaths (spoiler alert—it is):
Spoiler alert: the study is not peer reviewed, it does not study the actual Covid deaths in California but just the excess deaths during a certain period of time. You notice the study says "associated" with Covid 19 not caused by Covid 19, it does not study the deaths certificates of those in question. Those working age adults could have died from anything else including heart atacks when they got their mortgage statements, drug overdoses, suicides, lack of medical screening and proper medical care not to mention stress and other related factors.

But what should trouble you with this study is that it states that working age adults (18-65) experienced a 22% increased mortality during Covid. This is actually a higher percentage than the overall excess mortality. What should this tell you? Less people over 65 died from Covid? This contradicts everything you know, right? But something I mentioned in the past.

1611449275044.png




I know you will laugh hard (in case you did not look at it before you posted it), according to your study the computer jobs have a Covid mortality risk right in the middle, ahead of the nurses and way ahead of bartenders. I guess the computer viruses are more lethal than the Coronaviruses!. You know who has even higher risk according to the study? Customer service representatives. I guess all those reps working from home have been infected through the telephone.

Maybe the excess mortality has something to do with other factors, like the lockdowns and the economic misery ;). Maybe 7 hours a day of Facebook bickering and Netflix binge watching are not healthy either.
1611449853641.png
 
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In the meantime, life carries on in Ghana.

 
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1612152564572.png


Regarding infectiousness, the PCR test is not designed to identify active infectious disease but rather genetic material (dead, alive or partial) from the virus. PCR amplifies this material in samples to find traces of COVID-19, so while it often identifies people with active, infectious disease, it can also indicate people as "positive" erroneously. Dead COVID-19 RNA in the nose or mouth of someone who was never sick could create a positive PCR result. Recovered patients who test negative and are non-infectious can still come up positive repeatedly in the following months. These are neither new cases nor infectious ones needing quarantine but could be incorrectly counted as such.

www.msn.com/en-us/news/politics/appropriate-use-of-pcr-needed-for-a-focused-response-to-the-pandemic/ar-BB1ddIMX
 

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I am going to ask again. Why don't we know the number of cycles for every single PCR test that has been declared "positive"? It seems this is very relevant information.


1612153317678.png


"Discussion An analysis evaluating the infectiousness of patients hospitalized with covid-19 reported that only viral loads > 10 million copies/mL, equivalent to Cts ≤ 25, were associated with isolation of infectious virus from the respiratory tract.9 A complementary systematic review published 12/3/30 by the Oxford University Center for Evidence-Based Medicine confirmed that covid-19 rtPCR testing patient sample Cts >30 (mean from 6-studies) are associated with an inability to culture live virus, i.e., are non-infectious."

"Using a comparable cutpoint, a priori, i.e., Cts >32,2 we externally validated these findings by demonstrating that statewide Rhode Island covid-19 mortality dropped precipitously from March to June, 2020, as mean covid-19 positive test Cts from our RISHL sample rose above 32. "

1612153757922.png


 

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Will we be flexible, or will we keep reducing dissonance by insisting that our earliest decisions were right?
To demonstrate interconnection, just play Six Degrees of Kevin Bacon, now apply that to our mundane lives and you will see the futility of that concept.
and yet many demonstrate inflexibility in thinking- anything that doesn’t support their tribal way of thinking is picked apart, while things that do are outlandishly defended. (See Sweden argument ;) ) Completely agree on the inter connectivity. Why it’s frustrating with the “just stay home” crowd- they don’t see how connected they are to the ones who can’t stay home - food industry, trucking industry (and then suppliers to fpgas stations, mechanics, food etc). And the ones who refuse to do any risk mitigation as well.
And so YOUR solution is to increase false negatives, increase spread of disease, increase deaths? Sure, that'll certainly solve the economic impact of a pandemic. :rolleyes:

Maybe I'm an outlier, but seems to me the best way to recover the economy, get business back, and return to "normal" is to NOT get sick. I don't see increasing cases, the intent of what you think is "right," as the solution to anything. To the contrary, it is the problem. Ask Sweden.

The implicit "it's all a hoax" viewpoint is not very convincing to ER and ICU staff, not to mention the coroners and funeral homes. Or anyone else with their head above the sand.
Has been addressed BUT SO SICK OF BEING TOLD IM AN IDIOT, DENIER, ANTI-whatever just for questioning the reasoning. Since when did examining all sides become taboo? This virus IS real. I’ve watched it DEVASTATE my LTC population. I’ve watched the toll the ISOLATION has taken on the residents too. Yet THAT part is NEVER allowed to be discussed without accusations of “killing grandma”. I point out the masks studies showing actual inconclusive data, or point out the studies “proving” masking work only show reduced flow of particles (not transmission of infectiousness) or that nearly who draw that conclusion use N95 properly fitted under lab conditions and I’m called “anti-masker”. If masks are the absolute panacea WHy when my LTC all had cloth masks mandatory (until K95 could be obtained) for all staff (all - no exceptions) since March 2020 did the virus continue to ravage the population? Remember no outside people allowed at all! If the mask protect “you” more than “me” why did the residents get so sick and die? Presumably trained staff knew how to properly wear masks (many were using double even then). Being allowed to actually question and reason and discuss this earlier last year may have also saved lives! STILL no standard manufacturing process for cloth masks btw.
And why is the ONLY solution “increase false negatives?” Why can’t rapid testing that detects higher viral loads (like those at most infectious) be done in place? Michael Mena has been advocating for months for this, but it’s not “perfect” so “experts” won’t allow it. Because what worked before is suddenly no longer accepted during OMG ITS COVID crowd. Anecdotally the only building of mine that hasn’t had a widespread outbreak is the one doing rapid testing since last fall. With back up PCR if positive rapid. Hmmm wonder why that worked so well?:unsure:
Joining the hosts of This Week in Virology in July,
. Love TWiV! Did you listen to episode where Vincent himself got a false positive PCR? And broke down the exact way a PCR works and why false positives happen - including the studies to back up culturing the virus etc? I also appreciate they way they break down the “new” variants - way better than a science illiterate popular press “journalist” going for the scary click bait headline.
good. It is that constant balance. All the restrictions we impose will also be harmful to health in one way or another - long term or short term. You have to be aware of that."
He’s correct but that means a hard look at what works and doesn’t- and what politician is going to give up THAT power?
My MIL also kept saying she had never experienced a loss of freedom as we have in these times.
Again- I’m am so sorry for your loss. From the way you talk about her this loss will hurt a long time, she seemed a pretty unique lady!
hope the vaccines work
Doesn't matter unless 100% effective against every known and possible mutation from now to forever- those who are on power trips will find some way to spin it to control you. Just look at the stupid way the messaging is going right now! “Get vaccinated for a disease most will never know they have and for which 99% of population is low risk but hey- you STILL cannot relax a single teeny bit even around others recovered or vaccinated!” Because it’s not “safe” (ooh I hate that word now- whatever happened to risk mitigation? 100% Safe never was an option pre-covid but it must be now!)
I got my second shot last week- because I’m basically threatened with no job if I didn’t. I do think the ones approved here are safe, and have no issues getting it. I bristle at being “forced” however. Wrong approach. Huge vax fan, but when I’ve had concerns with kids vax (think it was when rotavirus one came out that cases intussusception in babies) the pediatricians calmly explained benefits/risks. With one of my kids the doc himself thought holding off that one was fine. The polio vax changed with each of my kids. But suddenly we aren’t allowed to question anything r/t covid- just shamed as “anti-“
Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
Yes my weekly test results show on the bottom to NOT to use as a sole DIAGNOSTIC tool for diagnosis of a disease yet that is exactly what’s been done from the start! Yeah so called asymptomatic- have to have a TEST to show you have with a disease without any symptoms! Even sars cov 1 had clinical symptoms described! Wonder how many MDs looks at a single lab- say a glucose of 154 and positively pronounces “yep you have diabetes!” Let’s get you on medicines right now!” All with no further investigation of any kind!
FYI this has been questioned a lot for months now, yet when pointed out to the “follow the science” crowd it’s 100% ignored. I’m all for science, but ALL interpretations of data should be considered and discussed, and if interpretations are faulty or inconclusive then they should be clearly refuted- not shouted down, called names or called for being fired!
covid-19 is responsible for the measurable increase in American deaths (spoiler alert—it is):
Yes this is a new disease that has deadly consequences for a portion of population and I’m not doubting many lost their lives prematurely due to covid. Those were ones with SYMPTOMS though.


So frustrated reasoning has left the country (don’t care your political affiliation- it’s everywhere).
 

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"Viral culture was positive only in samples with a cycle-threshold value of 28.4 or less. The incidence of culture positivity decreased with an increasing time from symptom onset and with an increasing cycle-threshold value (Table S3). "

Let's not forget that until recently WHO recommended 40 amplifications.




1614017606470.png
 

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Yes this is a new disease that has deadly consequences for a portion of population and I’m not doubting many lost their lives prematurely due to covid. Those were ones with SYMPTOMS though.
Until you can demonstrate with reasonable certainty that without symptoms you cannot cause the disease in another person, or contribute to undected spread of the disease, your argument contributes to the problem — and the deaths — not to the solution or a return to normal.

By (weak) analogy, there are or were a LOT of individuals with AIDS that had no symptoms at all, but were the proximate cause of a lot of deaths.

So too COVID. Sure, only those ”with symptoms” die. Indeed, dying is the ultimate “symptom.“ But how many died because they got infected by someone that did not have symptoms?

I do not know the point you are trying to make.
 

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Until you can demonstrate with reasonable certainty that without symptoms you cannot cause the disease in another person, or contribute to undected spread of the disease, your argument contributes to the problem — and the deaths — not to the solution or a return to normal.

By (weak) analogy, there are or were a LOT of individuals with AIDS that had no symptoms at all, but were the proximate cause of a lot of deaths.

So too COVID. Sure, only those ”with symptoms” die. Indeed, dying is the ultimate “symptom.“ But how many died because they got infected by someone that did not have symptoms?

I do not know the point you are trying to make.


You are making an interesting and valid argument and not for the first time. When we know the economic and human devastation produced by lock-downs and other mitigation measures would you not want to know the answer to that question? Where is the research commissioned by CDC or WHO in that respect? We have had this virus for a year, probably more, and we do not have a good answer about the transmission of the virus from those labelled "positive" but from PCR tests with a high number of amplifications?

I would like to make one more point. The WHO currently recommends that the number of amplifications be included in the decision. Do you have any evidence that has actually happened? I will quote again from the study I posted above:
"Viral culture was positive only in samples with a cycle-threshold value of 28.4 or less" If you were a clinician, would you not want to know if the person you are treating had a test with 42 cycles or 25?

I added the yellow lines in case the graph was not obvious enough

1614022797023.png
 
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You are making an interesting and valid argument and not for the first time. When we know the economic and human devastation produced by lock-downs and other mitigation measures would you not want to know the answer to that question? Where is the research commissioned by CDC or WHO in that respect? We have had this virus for a year, probably more, and we do not have a good answer about the transmission of the virus from those labelled "positive" but from PCR tests with a high number of amplifications?

I would like to make one more point. The WHO currently recommends that the number of amplifications be included in the decision. Do you have any evidence that has actually happened? I will quote again from the study I posted above:
"Viral culture was positive only in samples with a cycle-threshold value of 28.4 or less" If you were a clinician, would you not want to know if the person you are treating had a test with 42 cycles or 25?

I added the yellow lines in case the graph was not obvious enough

View attachment 32645
Without getting political, suffice to say that the prior administration had no interest in science or COVID. What we do know is that almost universally around the world, one country after another, from NZ/Australia to Iceland, Europe, South America, you name it, friends and enemies alike, all decided that the risk to human life from the virus outweighed those immediate concerns. Indeed, MUCH more than America — hence we have FAR FAR more death per capita than anyone else. 5% of the population and 20%+ of the deaths. “Winning” indeed.

The fact is, NZ and Australia and Israel and many other places managed to both suppress the viral spread, minimize deaths, and appear to be doing fine (relatively speaking) financially.
 

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@csodjd as a reminder, according to the

"WHO guidance Diagnostic testing for SARS-CoV-2 states that careful interpretation of weak positive results is needed (1). The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load. Where test results do not correspond with the clinical presentation, a new specimen should be taken and retested using the same or different NAT technology. "

Do you know if this is happening or not? Do you know how the decisions positive/negative were made last year?

 

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Without getting political, suffice to say that the prior administration had no interest in science or COVID. What we do know is that almost universally around the world, one country after another, from NZ/Australia to Iceland, Europe, South America, you name it, friends and enemies alike, all decided that the risk to human life from the virus outweighed those immediate concerns. Indeed, MUCH more than America — hence we have FAR FAR more death per capita than anyone else. 5% of the population and 20%+ of the deaths. “Winning” indeed.

The fact is, NZ and Australia and Israel and many other places managed to both suppress the viral spread, minimize deaths, and appear to be doing fine (relatively speaking) financially.
Sorry, this research had to be demanded/ ordered by the scientists not by politicians. Nice try. The politicians, like most of the public, do not even know about the PCR cycles because the media were not interested in a story that would have potentially made things appear less grave. If you find any evidence that the CDC/ NIAID recommended such studies and that the past administration refused to fund them, I will accept your argument.
 
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Sorry, this research had to be demanded/ ordered by the scientists not by politicians. Nice try. The politicians, like most of the public, do not even know about the PCR cycles because the media were not interested in a story that would have potentially made things appear less grave. If you find any evidence that the CDC/ NIAID recommended such studies and that the past administration refused to fund them, I will accept your argument.

I will not discuss here the virtues of locking down a country or a state, we have been beating that horse for a while but the California vs Florida comparison does not help your argument.
What the public knows about is that about 500,000 Americans have died from COVID, which means a HECK of a lot of people have been infecting others. I still fail to see your point, other than that you think perhaps 1,000,000 should have died in order to ENSURE that there were no false positives. You are entitled to your view that the cost of lock downs is greater than the cost of people dying. Most of the world appears to have a different view.
 

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What the public knows about is that about 500,000 Americans have died from COVID, which means a HECK of a lot of people have been infecting others. I still fail to see your point, other than that you think perhaps 1,000,000 should have died in order to ENSURE that there were no false positives. You are entitled to your view that the cost of lock downs is greater than the cost of people dying. Most of the world appears to have a different view.

That is a weak argument since we do not know the number of amplifications used for those 500,000 people and if the virus was active or not and actually contributed to all these deaths. By the way, CDC expected the number of new cases and deaths to go up in February but the number of new "covid" deaths is down 50%. What is your explanation?
 
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CDC expected the number of new cases and deaths to go up in February but the number of new "covid" deaths is down 50%. What is your explanation?
They predicted we'd have 514,000 deaths by Feb. 20. Looks like they nailed it.

"The United States is projected to record as many as 514,000 deaths from the coronavirus by Feb. 20 based on the country's current trajectory, the head of the Centers for Disease Control and Prevention (CDC) said Wednesday."

 

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They predicted we'd have 514,000 deaths by Feb. 20. Looks like they nailed it.

"The United States is projected to record as many as 514,000 deaths from the coronavirus by Feb. 20 based on the country's current trajectory, the head of the Centers for Disease Control and Prevention (CDC) said Wednesday."

Before the CDC expected the number of new cases and new deaths to go up not down. When they saw it was sunny outside already, they changed the "forecast" and asked people to leave the umbrellas home lol. "Despite a report the CDC published a month ago predicting that COVID cases would likely keep growing through February, US COVID-related hospitalizations are down almost 50% over the past month."


 
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"Roger"

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Current number of excess deaths since a year ago February, somewhere between 478,927 and 594,204. If you check the number of total deaths above average by cause (such as respiratory disease chiming in at about 6,000 more deaths than expected), you will see that these numbers do not add up to anywhere near the above totals. That is because most of the covid deaths were not co-listed, but simply listed as covid deaths. The biggest category, by far, where there was an increase in excess deaths was with Alzheimer's disease (about 45,000 more than expected). Why? Nursing homes were especially hard hit with covid and many Alzheimer's patients are in nursing homes.


The bottom line is I just don't see how too many amplifications of PCR cycles producing false positives can account for so many excess deaths over the last year.
 
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