In the months since the spread of COVID-19 was declared a pandemic by public health authorities a debate has raged over how dangerous the virus truly is, the effectiveness of masks and social distancing, and even whether the virus exists at all. Setting aside most of those debates for a moment, one of the driving forces of skepticism centers around the testing and reporting of cases. You may, in fact, know someone in your family or friends circle who is hesitant to wear a mask, or stay home because they have doubts about the case numbers. Alternatively, you may be one of the people who have a growing list of questions related to the reporting and handling of COVID-19.
In the interest of dialogue and understanding, here are five reasons your friends mistrust COVID-19 case numbers:
1. Rule Change Exposed by Collin County, Texas
Earlier this summer a presentation from the Collin County Commissioners Court went viral, making waves in the alternative media while being largely ignored in the mainstream press. During the May 18 presentation, Aisha Souri, an epidemiologist with Collin County Health Care Services, explained that under new guidance from the Texas Department of State Health Services (DSHS) the rules for determining a positive COVID-19 case were going to be changing.
The rules state that a “confirmed” case requires a positive polymerase chain reaction (PCR) lab test which detects SARS-CoV-2 RNA in a clinical specimen (more on the PCR test in a moment). However, the state’s expanded criteria would allow “probable” cases to be counted among confirmed cases. During the viral presentation, Souri noted that one could be deemed a probable COVID-19 case without exhibiting any symptoms at all. Under the new rules up to 15 people could be listed as “probable” if they came in contact with someone else labeled “probable.”
“But now they’ve added a ‘probable’ case definition,” Souri stated during the May 18 meeting. “So, that still gets counted toward the case count. It’s different—it’s not confirmed, but it’s still a case.”
Collin County Commissioner Court Judge Chris Hill said that a “subjective fever” or headache and residence in Collin County would qualify someone as a probable COVID19 patient under the rule change. “It is remarkable how low the standard is now,” Hill stated. Hill also warned that an increase in false positives would result in unnecessary quarantines, contact tracing, and stress on the health department’s resources. “None of these help us stop the spread of COVID-19, nor do they strike a prudent balance between public health priorities and individual concerns,” he said.
The outrage on social media and in Texas towns grew to the point that the authorities responded. Hill and Souri pinned the blame on the Texas DSHS following orders from the CDC. The Texas DSHS COVID-19 case website added the disclaimer, “Probable cases are not included in the total case numbers.” Even Texas Governor Greg Abbott acknowledged the controversy when asked point-blank if the confirmed cases included probable cases. “The two are not intermixed at all,” Abbott told Fox 4 News in Dallas-Ft. Worth.
So what happened? It’s clear that after the May 18 presentation went viral, the Texas DSHS opted out of following guidelines which suggested combining confirmed and probable cases. In late May the Texas Scorecard reported the CDC and Texas DSHS acknowledged that they had “been improperly combining active infection and antibody test numbers since May 13.” A source within the Collin County Health Department confirmed that the presentation given by Aisha Souri created a polarizing situation within the Collin County Commissioner’s Court.
What is less clear is when exactly the Texas DSHS decided to stop the combining of confirmed and probable cases, whether the probable cases were later removed from the confirmed list, and if there are other discrepancies in the counting. As we see below in San Antonio and Texas, there are still problems with other counties and states combining probable and confirmed cases.
2. 3,484 Probable Cases in San Antonio, TX Removed from Confirmed List
Just days ago the Texas Department of State Health Services announced it removed 3,484 cases from its statewide total. The Texas DSHS blamed the San Antonio Health District for not separating probable cases from confirmed cases. Texas health authorities changed the number of cases to reflect the removal of the probable cases and instructed San Antonio Metro Health to send their case counts separately.
The issue with these probable cases was the type of test. The 3,484 cases were not PCR tests but antigen tests, which are FDA-approved rapid detection tests. They are not the same as antibody tests, which can tell whether an individual was previously infected. Some researchers believe the antigen tests may not detect all active infections and thus a negative antigen test is usually followed by a PCR test. Metro Health officials said the antigen tests were approved for emergency use by the FDA between May 8th and July 2nd.
The CDC considers antigen tests to be presumptive cases which are included in the national COVID-19 case numbers. San Antonio Metro Health Director Dr. Colleen Bridger acknowledged that Metro Health was following CDC rules when she told the Austin Statesman that, “San Antonio is one of only three Texas cities collecting and reporting this data per the CDC guidelines, but the State of Texas wants apples-to-apples comparisons between Texas cities.”
The Texas DSHS told the Statesman that their website now only reflects confirmed cases. Despite the removal of the 3,400 cases, the San Antonio Metropolitan Health District website states that their case totals “include both confirmed and probable cases.”
3. Extremely High Positivity Rates Found to be False in Florida
A recent investigation by a local FOX affiliate in Florida found that the Florida Department of Health’s data on COVID-19 tests included errors in the rate of positivity. FOX 35 News found that some laboratories have not been reporting negative test results to the state. FOX 35 in Orlando reported:
“Countless labs have reported a 100 percent positivity rate, which means every single person tested was positive. Other labs had very high positivity rates. FOX 35 News found that testing sites like one local Centra Care reported that 83 people were tested and all tested positive. Then, NCF Diagnostics in Alachua reported 88 percent of tests were positive.
How could that be? FOX 35 News investigated these astronomical numbers, contacting every local location mentioned in the report.
The report showed that Orlando Health had a 98 percent positivity rate. However, when FOX 35 News contacted the hospital, they confirmed errors in the report. Orlando Health’s positivity rate is only 9.4 percent, not 98 percent as in the report.”
FOX 35 also found that the Orlando Veteran’s Medical Center reported a positivity rate of 76 percent, but a spokesperson for the VA told FOX 35 News that the positivity rate for the center is actually 6 percent.
WFTL reported that some experts believe Florida officials might actually be downplaying the severity of COVID-19 by underreporting positive tests. This could be because a person who tests positive is counted only once, but if a person gets tested multiple times with negative results each time, each negative test result is counted.
Dr. William Hanage, associate professor of epidemiology at Harvard’s T.H. Chan School of Public Health, told WFTL, “There is a peculiar odor around the data in Florida and there has been for some time.”
Whatever way you slice it, it’s clear there are problems with case reporting in Florida.
Another example of funny numbers includes the recent death of a Florida resident as a result of a motorcycle accident. Reporters found that one of the two COVID-19 victims in their 20s had died from an accident. FOX 35 reporters asked Orange County Health Officer Dr. Raul Pino if the man’s data was removed and he claimed he didn’t think so.
“We were arguing, discussing, or trying to argue with the state. Not because of the numbers — it’s 100…it doesn’t make any difference if it’s 99 — but the fact that the individual didn’t die from COVID-19…died in the crash,” Pino told FOX 35. “But you could actually argue that it could have been the COVID-19 that caused him to crash. I don’t know the conclusion of that one.”
4. UK Health Authorities Pause Death Toll Stats After ‘Over-Exaggeration’ Revealed
The UK health secretary Matt Hancock made headlines late last week after he called for an “urgent review” of the daily COVID-19 death numbers produced by Public Health England when it was revealed the stats included people who died from other causes. PHE is the lead agency under the UK Department of Health and Social Care. The Guardian reported:
“The oddity was revealed in a paper by Yoon K Loke and Carl Heneghan of the Centre for Evidence-Based Medicine at Oxford University, called “Why no one can ever recover from Covid-19 in England – a statistical anomaly”.
Their analysis suggests PHE cross-checks the latest notifications of deaths against a database of positive test results – so that anyone who has ever tested positive is recorded in the COVID-19 death statistics.
A Department of Health and Social Care source said: ‘You could have been tested positive in February, have no symptoms, then hit by a bus in July and you’d be recorded as a COVID death.'”
Only days after Hancock called for the review of PHE data, the UK government put an immediate halt to its daily update of death numbers from COVID-19. The PHE website now states, “On 17 July, the Secretary of State asked Public Health England (PHE) to urgently review the way daily death statistics are currently reported. We’re pausing the publication of the daily figure while this review takes place.”
5. How Reliable Are the PCR Tests?
Most of the previous four points focused on the discrepancies between probable and confirmed cases, but what about the test itself? As mentioned above, the most common test is a polymerase chain reaction (PCR) lab test. This incredibly sensitive technique was developed by Berkeley scientist Kary Mullis, for which he was awarded the Nobel Prize in 1993. The test is designed to detect the presence of a virus by amplifying the virus’ genetic material so it can be detected by scientists. The test is viewed as the gold standard, however, it is not without problems.
In a recently published piece on The Conversation, Maureen Ferran, Associate Professor of Biology, Rochester Institute of Technology, outlined some of the issues with the PCR tests. Ferran noted that researchers at the Foundation for Innovative New Diagnostics, a nonprofit research center in Geneva, tested five COVID-19 RT-PCR tests and found that all five achieved 100% sensitivity on positive samples, and at least 96% specificity on negative samples in a laboratory setting.
However, Ferran cautioned, “in the real world, testing conditions and process are far from perfect, and accuracy suffers. Researchers still don’t know what the real-world false positive rate is, but clinical sensitivity of RT-PCR tests ranges from 66% to 80%.”
This means the PCR tests could be false positives 20 to 44 percent of the time in non-lab conditions.
A recent report from NPR also outlines the dangers of false positives with the PCR tests. Andrew Cohen, director of the Center for Research on Aquatic Bioinvasions, was hired by the state of California to study an invasion of non-native mussels. The researchers took water samples and used a PCR test to search for genetic material from the mussels. After the tests came back overwhelmingly positive, Cohen grew suspicious.
“I began to realize that many of these — if not all of these — were false positives, especially when they started being reported in waters that had chemistry that would not allow the mussels to reproduce and establish themselves,” he told NPR. NPR notes that, depending on the lab, there was a 2 to 8 percent false positive rate.
Once COVID-19 was declared a pandemic, Cohen said he began asking if the reports of people with absolutely no symptoms and positive PCR test results could be false positives. “I began wondering whether these asymptomatic carriers weren’t in large part or in whole part the human counterparts of those false-positive results of quagga and zebra mussels in all those water bodies across the West,” he said.
Dr. Bobbi Pritt, a clinical microbiologist who chairs the microbiology committee for the College of American Pathologists, told NPR that Cohen’s numbers seem “reasonable” because the PCR test is incredibly sensitive and contamination is a particular concern. “That viral material could get into the environment and then contaminate your specimens around you and then cause false positives in those specimens,” Pritt told NPR.
Cohen emphasized the importance of researchers taking potential false positive PCR results seriously. “As near as we can tell, the medical establishment and public health authorities and researchers … appear to be assuming that the false-positive rate in in the PCR based test is zero, or at least so low that we can ignore it.”
Cohen is correct that the scientific authorities need to take false positives seriously, especially when a person can be sent to isolate or quarantine for weeks due to a positive test result. Even the U.S. FDA’s own fact sheet on testing acknowledges the dangers posed by false positives:
“The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.”
A CDC fact sheet also acknowledges the possibility of false positives with the PCR test.
Finally, even during a Reuters “Fact Check” on PCR inventor Kary Mullis, a spokesperson for Public Health England told Reuters, “It is important to note that detecting viral material by PCR does not indicate that the virus is fully intact and infectious, i.e. able to cause infection in other people.”