Monday, July 27, 2020

Consistent Inaccuracies in COVID-19 Testing and Reporting

 

Consistent Inaccuracies in COVID-19 Testing and Reporting


Analysis by Dr. Joseph Mercola Fact Checked



Story at-a-glance

  • A suspiciously high number of laboratories in Florida are reporting 100% of COVID-19 viral tests as positive. It appears many labs may be submitting positive results only, omitting negative results altogether
  • In Florida, while each positive test result is counted as a “case,” a single person may have two or more test results. So, one infected individual can be counted as two “cases”
  • Some states have also excluded negative test results from their reporting, thereby giving us an incomplete and misleading picture of the spread of the disease across the country
  • If the prevalence of infection in the community is 1%, and you have a test that’s only 99% specific, then about 50% of all positive tests will be false positives
  • The BD SARS-CoV-2 Reagents for the BD Max System test has a 3% false positive rate. The Cellex antibody test, which has a reported sensitivity of 94% and specificity of 96%, delivers unacceptably high rates of false positives
The only consistent thing about COVID-19 testing and reporting so far is their inconsistency. Head-scratching "errors" have plagued us from the get-go, and it sure doesn't seem to be getting any better. I guess it just goes to show that even with access to incredible data-crunching technology, human ineptitude will ensure no one becomes the wiser.
Faulty or contaminated tests have been used and reporting guidelines have been changed and updated multiple times, virtually eliminating any possibility of accurately tracking infected cases and deaths.
Most recently, a July 17, 2020, study1,2 in the International Journal of Geriatrics and Rehabilitation concluded half of all nucleic acid coronavirus tests distributed by the Centers for Disease Control and Prevention provided inaccurate results — 30% being false positives and 20% false negatives.
Suspicions that many were dying with SARS-CoV-2 infection rather than from COVID-19 have circulated for many weeks, and now Florida has admitted a young man listed as a COVID-19 death actually died in a motorcycle accident.3 It just so happens he tested positive for SARS-CoV-2 infection. Things like that surely do not inspire public trust.

Mainstream Media Distortion of the Testing Truth

Perhaps the most egregious misrepresentation of reality is the media's conflating a positive test result with the actual disease, COVID-19. These tests only test for the virus directly (PCR tests) or antibodies to the virus. COVID-19 is NOT a positive test; it is a clinical diagnosis of someone infected with SARS-COV-2 exhibiting severe respiratory illness characterized by fever, coughing and shortness of breath.
The media is intentionally confusing a positive test result with COVID-19 to deliberately mislead the public into believing the disease is far more serious than it is. They know better but consciously choose this despicable practice. A recent example would be CNN's article, "Florida Has More COVID-19 Than Most Countries in the World."4
They refer to the positive test as a "case." This is beyond stretching reality to suit their nefarious purposes. A case is NOT a positive test result but, rather, a person that has a positive test result and is seriously ill. But you would never know it by reading their article.
Further down in their fear-mongering article is a subhead, "Florida Has Surpassed Italy in COVID-19 Cases, Too." But at the very end of the article they finally admit the truth: Even though Florida surpassed Italy in "cases," they had nearly 90% FEWER deaths — the metric that really counts, unless your goal is to perpetuate needless fear into the population.

Some Labs Appear to Only Report Positive Results

One of the latest scandals was highlighted in a July 11, 2020, Twitter post5 by a user named Rebel A. Cole. A suspiciously high number of laboratories in Florida are reporting6,7 100% of tests as positive. Cole wonders whether this means many labs are now only submitting positive results, omitting negatives altogether.
Cole points out that the results from labs reporting only positives account for 34% of the 10,360 new cases on July 11. "Without these, today's 'percent positive' would fall from 12.6% to 8.7%" Cole said.
florida lab results
The same anomalous trend was also reported in the Alachua Chronicle, July 7, 2020:8
"It looks like North Florida Regional and Shands are reporting at least some negatives, but we now know that UF is not reporting negatives in employee testing to the state. 
By law, all test results by physicians, hospitals, and laboratories are required to be reported to the state, but the list of labs reporting 100% positives indicates that's not happening — or perhaps tests performed by an employer are not covered by the order …
If negative tests aren't reported, they aren't added to the total number of tests. That makes the reported positivity rate higher than the actual positive percentage of all tests performed. This can easily be seen when you look at the hospitals reporting 100% positive tests.
If they reported 50 positives with 100% positive tests, for example, the number of tests reported to the state is 50. If they did 500 tests to get those 50 positives, 450 tests were not reported to the state and were not added to the total number of tests reported by the state."
Confusing matters further, the Florida testing report9 states that "A person can be tested by more than one laboratory and can have both positive and negative results."
In other words, while each positive test result is counted as a "case," a single person may actually have two or more test results. Let's say one individual tests positive twice or even three or four times. They're now counted as two or more "cases" when in fact it's just one person.
Add to that the fact that in many areas, "assumed" cases — obtained through contact tracing — are counted as "positive cases" as well (or have been in the past), even without laboratory confirmed testing.10
After a local Fox News affiliate contacted several of the Florida labs reporting 100% positive test results, some of them confirmed "major errors" in their reporting. And they're no small errors. Orlando Health confirmed its positivity rate was not 98%, as reported to the state, but rather 9.4%. Similarly, Orlando Veteran's Medical Center corrected its positivity rate from the reported 76% down to 6%.11
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Several States Report Only Positive Results

KHN.org actually reported12 this problem all the way back on March 25, 2020, warning that some states had chosen to exclude negative test results from their reporting, thereby giving us an incomplete and misleading picture of the spread of the disease across the country.
"Several states are reporting only positive COVID-19 test results from private labs, a practice that paints a misleading picture of how fast the disease is spreading," KHN wrote.
"Maryland, Ohio and others are posting the numbers of new positive tests and deaths, for instance, but don't report the negative results, which would help show how many people were tested overall.
'This matters because it gives you a false sense of what is going on in a particular location,' said Dr. Eric Topol, director of the Scripps Research Translational Institute.
He said states should be required to report both positive and negative results for review by public health experts. 'They should all be pulled together,' Topol said. 'It should be automatic.'"

Tests Are Reliably Unreliable

Aside from single individuals being counted as multiple "cases" if they have more than one positive test, the accuracy of the tests themselves have also come under question numerous times. For example, in June, Texas noticed an abnormal number of positive test results, which threw the accuracy of the tests into question. As reported by Dallas News:13
"The state is no longer using a laboratory that has tested 14,000 Texans for the coronavirus, after it turned up an abnormal number of positive results during state-ordered testing at nursing homes and in community surveillance …
It is not clear whether all the lab's test results will be thrown out from state tallies or just a portion. A spokeswoman for HHSC declined to name the lab, saying only that it was a private one."

Low Prevalence = Higher False Positive Rate

As explained by Dr. Deborah Birx during an April White House Coronavirus Task Force briefing, COVID-19 tests are "not 100% sensitive or specific," and that when prevalence is low in the community, the false positive rate will be high.

"If you have 1% of your population infected, and you have a test that's only 99% specific, that means that when you find a positive, 50% of the time will be a real positive and 50% of the time it won't be," Birx said.
In other words, if the prevalence of infection in the community is 1%, about half of all positive tests will be false positives. Depending on the manufacturer, the test may return even higher rates of false results.

Some Tests Have High False Positive Rates, Others Negative

July 6, 2020, the U.S. Food and Drug Administration warned14 clinical laboratory staff and health care providers using the BD SARS-CoV-2 Reagents for the BD Max System test that the test had an increased risk of false positives.
The test is designed to detect viral nucleic acid from the SARS-CoV-2 virus in nasal swabs, providing results in two to three hours. "In one study, the manufacturer found approximately three percent (3%) of results were false positive results," the FDA said.
False negatives occur too, although it appears to be more difficult to find data on the prevalence of false negative test results. May 14, 2020, the FDA issued a public alert15 warning people that the Abbott ID NOW point-of-care test had a high false negative rate. The FDA started reviewing the test after receiving 15 adverse event reports.
"The agency has been working with Abbott … on a customer notification letter to alert users that any negative test results that are not consistent with a patient's clinical signs and symptoms or necessary for patient management should be confirmed with another test," the FDA said.
While there seems to be no reliable way to assess just how many positive test results are in fact false positives, as testing continues to climb, it seems clear the number of false results is likely to be quite high.
Meanwhile, hospitalizations and actual deaths have dramatically declined. The week of July 4, a grand total of 522 Americans died with or from COVID-19. The week of July 11, the death toll was down to 181, and that's for the entire nation.16
Mortality peaked the week of April 18, with 16,897 deaths, and has dropped by the thousands every week since. At this point, I think it would be safe to say we're out of the danger zone and should allow life to return to some semblance of normal.

False Positives Lead to Misuse of Medical Resources

False positives do more than fuel fear-based media rhetoric. In India, false positives are endangering patients who are actually sick by taking up much-needed hospital beds. As reported by Times of India:17
"… the dead virus is lingering on in some patients, throwing up false positive reports in those who have completely recovered and are in no danger, either to themselves or to others. This is keeping hospital beds occupied longer than strictly required and denying beds to patients who genuinely need them …"
While hospitals typically discharge patients once their symptoms have resolved, many are wary of leaving without proof that they're no longer infectious, as many family members, neighbors and even some housing complexes will not allow access to potentially infectious individuals.
"Both RT-PCR and TruNat tests are so sensitive that they can catch traces of the dead virus protein, causing the false positives, said Raja Dhar, Fortis Hospital pulmonologist.
'These patients are unlikely to transmit the virus and can safely be sent home. But they are reluctant because of the social pressure. Many plead with us to defer release until they test negative,' Dhar told TOI."18

Antibody Tests Are Equally Unreliable

Antibody tests are also turning out to have their share of quality problems. In a letter to the editor19 published in the July 1, 2020, issue of American Family Physician, Drs. Mark Ebell, deputy editor for evidence-based medicine for the journal, and Henry Barry, review some of the available data:
"Cellex, the first antibody test approved by the U.S. Food and Drug Administration for the virus, has a reported sensitivity of 94% and specificity of 96% ... 
When assessing whether patients had a previous infection and may be immune, it is important to avoid false-positives so that patients do not think they are immune when they are not.
Table 1 summarizes the false-positive rates at various population prevalence for the Cellex test and for a hypothetical test that is 90% sensitive and 99% specific.
At relatively low population prevalences, which likely reflect current conditions in the United States and elsewhere, we would argue that false-positive rates are unacceptably high with the Cellex test."
antibody testing covid-19
Ebell and Barry point out that many of the antibody tests that have provisional approval from the FDA still have not even been evaluated for accuracy. They also recommend that labs report test results "in a way that reflects the local population prevalence based on widespread testing and include the false-positive rate," as this information "is needed to help family physicians better inform shared decision-making regarding previous infection and return to work or school."
At present, you'd be hard-pressed to find anyone including that data in their reporting, and the way things are going, I wouldn't hold my breath in anticipation of such helpful numbers being included in the future either.

Viral and Antibody Test Results Have Been Combined

Aside from false positive viral and antibody tests, back in May the CDC also admitted it had combined test results from the two different tests in its national reporting.20
Ashish Jha, director of the Harvard Global Health Institute, told The Atlantic,21 "You've got to be kidding me. How could the CDC make that mistake? This is a mess." Indeed. Several states were also found to have comingled results from the two tests for varying amounts of time, including Pennsylvania, Texas, Georgia, Vermont, Virginia and Maine.22
At the state level, an idiotic error such as this has significant consequences as states use these data points to determine when it's "safe" to reopen their economies and allow people back to work.

Common Cold Antibodies Can Trigger False Positive Test

Still, there's more. June 30, 2020, the U.S. Centers for Disease Control and Prevention admitted that prior exposure to coronaviruses responsible for the common cold can result in a positive COVID-19 antibody test, even if you've never been exposed to SARS-CoV-2 specifically.23
The saving grace there is that studies24,25,26 suggest antibodies produced following exposure to coronaviruses that cause the common cold also appear to provide some general and long-lasting resistance against SARS-CoV-2.
One such study,27,28 published May 14, 2020, in the journal Cell, found 70% of samples from patients who had recovered from mild cases of COVID-19 had resistance to SARS-CoV-2 on the T-cell level, but so did 40% to 60% of people who had not been exposed to SARS-CoV-2.
According to the authors, this suggests there's "cross-reactive T cell recognition between circulating 'common cold' coronaviruses and SARS-CoV-2." In other words, if you've recovered from a common cold caused by a particular coronavirus, your humoral immune system may activate when you encounter SARS-CoV-2, thus rendering you resistant to COVID-19.
Another study29 discovered SARS-CoV-2-specific antibodies are only found in the most severe cases — about 1 in 5. So, a negative antibody test doesn't necessarily rule out the possibility that you've been infected and didn't get sick. In fact, this finding suggests COVID-19 may actually be five times more prevalent than suspected — and five times less deadly than predicted.

COVID-19 Lethality Has Been Massively Overestimated

Other research supports the hypothesis that COVID-19 lethality has been grossly overestimated. Data from a still-ongoing study30,31 by Wake Forest Baptist Health found that, so far, between 12% and 14% of people tested in North Carolina — about 1.47 million people — have antibodies for the coronavirus.
This means they were exposed to the virus, got infected and fought it off, all while experiencing few or no symptoms. Based on these data, the overall death rate appears to be around 0.1%.32 John Sanders, chief of infectious diseases at Wake Forest Baptist, told WFAE 90.7:33
"We can … say the death rate is lower than we have estimated. The severity of symptoms is lower than we estimated and the vast majority of people who were infected are going to do fine."
An overall mortality rate of 0.1% is right in line with statistics cited by Stanford University's disease prevention chairman Dr. John Ioannidis as well, who in a June 27, 2020, interview with Greek Reporter said:34
"0.05% to 1% is a reasonable range for what the data tell us now for the infection fatality rate, with a median of about 0.25%. For people younger than 45, the infection fatality rate is almost 0%. For 45 to 70, it is probably about 0.05-0.3%."35

31% of Tested Florida Children Are Positive for Coronavirus

July 14, 2020, the Florida Sun Sentinel reported that 31% of 54,022 children tested in the state were positive for coronavirus. "The state's positivity rate for the entire population is about 11%," the Sentinel said, implying that children in Florida are nearly three times as likely to be positive for the virus.
But, knowing how unreliable the tests are, how could health officials and the media possibly take the 31% positivity results seriously — especially considering that studies are showing that the virus affects children differently and less severely than it does adults?36

Do Positive Tests Even Matter at This Point?

If the vast majority of people who test positive for COVID-19 infection have no symptoms, don't feel sick and don't look sick, is COVID-19 really a "deadly" disease? Or, is it more like HPV — a viral infection that most people have without knowing it, and which 90% are able to eliminate without treatment?
To highlight just a single case, Texas Rangers outfielder Joey Gallo has tested positive for COVID-19 twice, yet he never developed any symptoms. He's also had several negative tests. "It was weird, it was hard to get real answers on if I really had it or not," he told KSAT.37
"The 26-year-old All-Star slugger missed the first week of the Rangers summer camp and isolated from teammates for two weeks after two positive tests that sandwiched a negative result during intake testing," KSAT reports.
"He had two negative tests on his own outside of the MLB testing program, but wasn't cleared to join the team until consecutive negative tests under the protocol …
Gallo's positive results were by the saliva test, though he was negative on a swab test. He said he is 'now on edge' when going through the testing and gets nervous every time he has to do a saliva test."

Continued Testing Now Merely Drives Irrational Fearmongering

The primary justification for the tyrannical governmental interventions of COVID-19 was to slow the spread of the infection so that hospital resources would not be overwhelmed, causing people to die due to lack of medical care.
These interventions were not about stopping the spread altogether or even reducing the number of people that would eventually get infected. They certainly were never meant to prevent all death. Logic dictates this simply isn't possible, under any circumstance.
The stay-at-home orders and business closings were only intended to slow down the spread so that, eventually, naturally-acquired herd immunity — the best kind — would prevent it from reemerging.
Now all of a sudden, the narrative has changed. There's no talk about flattening the curve anymore. The media rarely even mention the all-important death statistics. Instead, headlines warn of skyrocketing "cases," meaning completely healthy people who happen to test positive and who are unlikely to spend so much as a day in bed feeling poorly.
At the same time, people with simple upper respiratory infections can legally be classified as COVID-19 cases even without confirmed lab results,38,39 which artificially inflate the "case" totals even more.
The only rational reason for any of the government interventions is to continue to erode your personal freedoms and civil liberties and transfer wealth to those in control. It's all fearmongering based on a combination of wildly manipulated data and flawed tests. Hopefully, local and federal leaders will wisen up and start issuing saner guidance sooner rather than later.
Time will tell if the July 14, 2020, White House Coronavirus Task Force decision to remove COVID-19 data collection from the CDC will have any effect. As of July 15, all U.S. hospitals are directed to bypass the CDC and "send all coronavirus patient information" to a non-public Health and Human Services database in D.C. instead.40
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