NY Times: The “number of [PCR test] amplification cycles needed to find the virus...is never included in the results sent to doctors and coronavirus patients….C.D.C.’s own calculations suggest that it is extremely difficult [for a PCR test] to detect any live virus in a sample above a threshold of 33 cycles. Officials at some state labs said the C.D.C. had not asked them to note threshold values or to share them with contact tracing organizations….The Food and Drug Administration said in an emailed statement that it does not specify the [PCR test] cycle threshold ranges used to determine who is positive….The Centers for Disease Control and Prevention said it is examining the use of cycle threshold measures “for policy decisions.” The agency said it would need to collaborate with the F.D.A. and with device manufacturers.”…8/20/20, “Your Coronavirus Test Is Positive. Maybe It Shouldn’t Be,” NY Times, Apoorva Mandavilli, updated 1/19/21
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Added: Persons cannot be quarantined or confined based on results of a PCR test, per Lisbon Court of Appeals, 11/11/20, Original PortugueseP
“A. The prescription and diagnosis are medical acts, under the exclusive responsibility of a doctor, registered in the Order of Doctors.”
11/11/20, “Judgment of the Lisbon Court of Appeals,” Habeus Corpus Interest in acting Sars Cov 2 RT-PCR tests, Privacy of Freedom, Illegal Detention. Unanimity: Criminal resources provision denied
“A. The prescription and diagnosis are medical acts, under the exclusive responsibility of a doctor, registered in the Order of Doctors. B. In the case that now concerns us, there is no indication or proof, that such diagnosis was actually performed by a professional qualified under the Law and who had acted in accordance with good medical practices. In fact…none of the applicants was even seen by a doctor, which is frankly inexplicable, given the alleged seriousness of the [Covid] infection....C. The only element that appears in the proven facts, in this respect, is the performance of RT-PCR tests, one of which presented a positive result in relation to one of the applicants. D. In view of the current scientific evidence, this test is, in itself, unable to determine, beyond reasonable doubt, that such positivity corresponds, in fact, to the infection of a person by the SARS-CoV-2 virus, for several reasons….18. Thus, with so many scientific doubts,… as to the reliability of such tests,…and there being no diagnosis made by a doctor, in the sense of the existence of infection and risk, it would never be possible for this court to determine that AH had the SARS-CoV-2 virus, nor that SH, SWH, and NK_ had high risk exposure.”…
“[2] “at a cycle threshold(ct) of 25, 70% of samples remained positive in cell culture (ie were infectious); at a ct of 30, 20% of samples remained positive; at a ct of 35, 3% of samples remained positive; and at a ct above 35, no sample remained positive (infectious) in cell culture (see diagram) This means that if a person gets a “positive” PCR test result at a cycle threshold of 35 or higher (as applied in most US labs and many European labs), the chance that the person is infectious is less than 3%. The chance that the person received a “false positive” result is 97% or higher . [3] “…
“Importantly, no data suggests that detection of low levels of viral RNA by RT-PCR equates with infectivity unless infectious virus particles have been confirmed with laboratory culture based
methods.7…
To summarize, false-positive COVID-19 swab test results might be increasingly likely in the current epidemiological climate in the UK, with substantial consequences at the personal, health system, and societal levels (panel).”
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Added: NY Times: The “number of [PCR test] amplification cycles needed to find the virus...is never included in the results sent to doctors and coronavirus patients….C.D.C.’s own calculations suggest that it is extremely difficult [for a PCR test] to detect any live virus in a sample above a threshold of 33 cycles. Officials at some state labs said the C.D.C. had not asked them to note threshold values or to share them with contact tracing organizations.”
8/20/20, 1/19/21, “Your Coronavirus Test Is Positive. Maybe It Shouldn’t Be," NY Times, Apoorva Mandavilli
“This number of amplification cycles needed to find the virus, called the cycle threshold, is never included in the results sent to doctors and coronavirus patients.”…
In three sets of testing data that include cycle thresholds, compiled by officials in Massachusetts, New York and Nevada, up to 90 percent of people testing positive carried barely any virus, a review by The Times found….
The most widely used diagnostic test for the new coronavirus, called a PCR test, provides a simple yes-no answer to the question of whether a patient is infected….
“We’ve been using one type of data for everything, and that is just plus or minus––that’s all,” Dr. Mina said. “We’re using that for clinical diagnostics, for public health, for policy decision-making.”
But yes-no isn’t good enough, he added. It’s the amount of virus that should dictate the infected patient’s next steps. “It’s really irresponsible, I think, to forgo the recognition that this is a quantitative issue,” Dr. Mina said….
This number of amplification cycles needed to find the virus, called the cycle threshold, is never included in the results sent to doctors and coronavirus patients….
In three sets of testing data that include cycle thresholds, compiled by officials in Massachusetts, New York and Nevada, up to 90 percent of people testing positive carried barely any virus, a review by The Times found.
On Thursday [Aug. 2020], the United States recorded 45,604 new coronavirus cases, according to a database maintained by The Times. If the rates of contagiousness in Massachusetts and New York were to apply nationwide, then perhaps only 4,500 of those people may actually need to isolate and submit to contact tracing….
“I’m shocked that people would think that 40 could represent a positive,” she [Juliet Morrison, a virologist at the University of California, Riverside] said.
A more reasonable cutoff would be 30 to 35, she added. Dr. Mina said he would set the figure at 30, or even less….
The Food and Drug Administration said in an emailed statement that it does not specify the cycle threshold ranges used to determine who is positive, and that “commercial manufacturers and laboratories set their own.”
The Centers for Disease Control and Prevention said it is examining the use of cycle threshold measures “for policy decisions.” The agency said it would need to collaborate with the F.D.A. and with device manufacturers to ensure the measures “can be used properly and with assurance that we know what they mean.”
The C.D.C.’s own calculations suggest that it is extremely difficult to detect any live virus in a sample above a threshold of 33 cycles. Officials at some state labs said the C.D.C. had not asked them to note threshold values or to share them with contact tracing organizations.
For example, North Carolina’s state lab uses the Thermo Fisher coronavirus test, which automatically classifies results based on a cutoff of 37 cycles. A spokeswoman for the lab said testers did not have access to the precise numbers….
“It’s just kind of mind-blowing to me that people are not recording the C.T. values from all these tests-that they’re just returning a positive or a negative,” said Angela Rasmussen, a virologist at Columbia University in New York….
Officials at the Wadsworth Center, New York’s state lab, have access to C.T. values from tests they have processed, and analyzed their numbers at The Times’s request. In July, the lab identified 872 positive tests, based on a threshold of 40 cycles.
With a cutoff of 35, about 43 percent of those tests would no longer qualify as positive. About 63 percent would no longer be judged positive if the cycles were limited to 30.
In Massachusetts, from 85 to 90 percent of people who tested positive in July with a cycle threshold of 40 would have been deemed negative if the threshold were 30 cycles, Dr. Mina said. “I would say that none of those people should be contact–traced, not one,” he said.
Other experts informed of these numbers were stunned.
“I’m really shocked that it could be that high — the proportion of people with high C.T. value results,” said Dr. Ashish Jha, director of the Harvard Global Health Institute. “Boy, does it really change the way we need to be thinking about testing.”…
The number of people with positive results who aren’t infectious is particularly concerning, said Scott Becker, executive director of the Association of Public Health Laboratories….
Dr. Mina and other researchers are questioning the use of PCR tests as a frontline diagnostic tool.”…
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Added:
Among comments to “Portuguese Court Rules PCR Tests “Unreliable” & Quarantines “Unlawful.” Important legal decision faces total media blackout in Western world,” 11/20/20:
The Prosecutor, unhappy with the ruling, appealed the decision.
The Lisbon Court of Appeals (ruling made by a collective of 3 judges – one appointed as the head) not only confirmed the decision made by the lower court, but stated that the tests will highly unreliable (97%).
The judges in the Court of Appeals who made this courageous ruling are under intense scrutiny by even their peers
and their ruling will be debated and analyzed in a meeting to be held
by the CSM (Superior Council of Magistrates) – the highest body in the
Portuguese Judiciary.
They may be sanctioned for their decision and suffer penalties.
It´s really ominous when even the Judiciary becomes politicized.
These are dangerous times.”
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Added: More about Portuguese Court PCR test ruling from Off Guardian:
11/20/20, “Portuguese Court Rules PCR Tests “Unreliable” & Quarantines “Unlawful.” Important legal decision faces total media blackout in Western world.” Off-Guardian
Further, the ruling suggested that any forced quarantine applied to healthy people could be a violation of their fundamental right to liberty.
Most importantly, the judges ruled that a single positive PCR test cannot be used as an effective diagnosis of infection.
The specifics of the case concern four tourists entering the country from Germany – all of whom are anonymous in the transcript of the case – who were quarantined by the regional health authority. Of the four, only one had tested positive for the virus, whilst the other three were deemed simply of “high infection risk” based on proximity to the positive individual. All four had, in the previous 72 hours, tested negative for the virus before departing from Germany.
In their ruling, judges Margarida Ramos de Almeida and Ana Paramés referred to several scientific studies. Most notably this study by Jaafar et al., which found that – when running PCR tests with 35 cycles or more – the accuracy dropped to 3%, meaning up to 97% of positive results could be false positives.
The ruling goes on to conclude that, based on the science they read, any PCR test using over 25 cycles is totally unreliable. Governments and private labs have been very tight-lipped about the exact number of cycles they run when PCR testing, but it is known to sometimes be as high as 45. Even fearmonger-in-chief Anthony Fauci has publicly stated anything over 35 is totally unusable.
You can read the complete ruling in the original Portuguese here, and translated into English here. There’s also a good write up on it on Great Game India, plus a Portuguese professor sent a long email about the case to Lockdown Sceptics.
The media reaction to this case has been entirely predictable – they have not mentioned it. At all. Anywhere. Ever.
The ruling was published on November 11th, and has been referenced by many alt-news sites since…but the mainstream outlets are maintaining a complete blackout on it.”…
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