The Florida Department of Health is now requiring all laboratories conducting COVID-19 tests to document more details for the controversial PCR test.
On December 3, the Florida Department of Health announced a new update requiring all laboratories conducting COVID-19 tests to record new details for the polymerase chain reaction (PCR) test. The announcement came via an email update from the Medical Quality Assurance division of the Florida DOH addressed to all licensed health care practitioners.
The update, Mandatory Reporting of COVID-19 Laboratory Test Results: Reporting of Cycle Threshold Values, notes that all Florida “laboratories are subject to mandatory reporting to the Florida Department of Health (FDOH),” including for “PCR, other RNA, antigen and antibody results.” The update adds new requirements for the PCR test, asking labs to record the “cycle threshold” (CT) values for the process.
The PCR test uses chemicals to amplify the virus’s genetic material and then each sample goes through a number of cycles until a virus is recovered. This “cycle threshold” has become a key component in the debate around the efficacy of the PCR test.
The FDOH document states (emphasis added):
“Cycle threshold (CT) values and their reference ranges, as applicable, must be reported by laboratories to FDOH via electronic laboratory reporting or by fax immediately. If your laboratory is not currently reporting CT values and their reference ranges, the lab should begin reporting this information to FDOH within seven days of the date of this memorandum.”
The update asks labs who are unable to report CT values to fill out a questionnaire and submit it to the FDOH’s Bureau of Epidemiology within 7 days.
The fact that the Florida Department of Health is taking this step is a sign that an increasing number of health professionals and regulators are questioning the accuracy of the PCR test. The PCR is the most common lab test being used to detect COVID-19. 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.
On August 31, I attended a press conference in Houston and had a chance to ask Houston Health Authority Dr. David Persse about concerns around the test used to detect COVID-19. Dr. Persse said when the labs report numbers of COVID-19 cases to the City of Houston they only offer a binary option of “yes” for positive or “no” for negative.
“But, in reality, it comes in what is called cycle-thresholds. It’s an inverse relationship, so the higher the number the less virus there was in the initial sample,” Persse explained. “Some labs will report out to 40 cycle-thresholds, and if they get a positive at 40 – which means there is a tiny, tiny, tiny amount of virus there – that gets reported to us as positive and we don’t know any different.”
Persse noted that the key question is, at what value is someone considered still infectious?
“Because if you test me and I have a tiny amount of virus, does that mean I am contagious? That I am still infectious to someone else? If you are shedding a little bit of virus are you just starting? Or are you on the downside?,” Dr. Persse asked in the lobby of Houston City Hall. He believes the answer is for the scientific community to set a national standard for cycle-threshold.
Unfortunately, the problems associated with the PCR test are international in scope.
Problems in Portugal, the UK
On November 11, the Lisbon Court of Appeal ruled that the PCR test “is unable to determine, beyond reasonable doubt, that a positive result corresponds, in fact, to the infection of a person by the SARS-CoV-2 virus.” The decision relates to an appeal by the Regional Health Administration of the Azores – officially the Autonomous Region of the Azores in Portugal – who forced four German citizens to comply with a 14 day quarantine in a hotel room.
After the four citizens appealed the decision, the panel of judges concluded that “the number of cycles of such amplification results in a greater or lesser reliability of such tests. And the problem is that this reliability shows itself, in terms of scientific evidence (…) as more than debatable.”
The ruling went even further, stating, “in view of current scientific evidence, this test shows itself to be unable to determine beyond reasonable doubt that such positivity corresponds, in fact, to the infection of a person by the SARS-CoV-2 virus.”
Predictably, the judges’ ruling was questioned and criticized by health officials and some in the science community. One report notes that the judges might face disciplinary action. A report in Públicio says the judges from the Lisbon Court of Appeal misread two scientific articles they quoted in their ruling and the scientific consensus on PCR testing is “absolute”. Vasco Barreto, a researcher at the Center for the Study of Chronic Diseases (Cedoc) of the Faculty of Medical Sciences of the Universidade Nova de Lisboa, told Público the judges ruling was “false” and they had acted “irresponsibly”.
In the first weeks of September, a number of important revelations regarding the PCR test came to light in the UK. New research from the University of Oxford’s Center for Evidence-Based Medicine and the University of the West of England found that the PCR test poses the potential for false positives when testing for COVID-19. Professor Carl Heneghan, one of the authors of the study, Viral cultures for COVID-19 infectivity assessment – a systematic review, said there was a risk that an increase in testing in the UK will lead to an increase in the risk of “sample contamination” and thus an increase in COVID-19 cases.
The team reviewed evidence from 25 studies where virus specimens had positive PCR tests. The researchers state that the “genetic photocopying” technique scientists use to magnify the sample of genetic material collected is so sensitive it could be picking up fragments of dead virus from previous infections. The researchers reach a similar conclusion as Dr. David Persse, namely that, “A binary Yes/No approach to the interpretation RT-PCR unvalidated against viral culture will result in false positives with segregation of large numbers of people who are no longer infectious and hence not a threat to public health.”
Heneghan, who is also the the editor of BMJ Evidence-Based Medicine, told the BBC that the binary approach is a problem and tests should have a cut-off point so small amounts of virus do not lead to a positive result. This is because of the cycle threshold mentioned by Dr. Persse in Houston. A person who is shedding an active virus and someone who has leftover infection could both receive the same positive test result. He also stated that the test could be detecting old virus which would explain the rise in cases in the UK. Heneghan also stated that setting a standard for the cycle threshold would eliminate the quarantining and contact tracing of people who are healthy and help the public better understand the true nature of COVID-19.
The UK’s leading health agency, Public Health England, released an update similar to the Florida DOH on the testing methods used to detect COVID-19. PHE appeared to agree with Professor Heneghan regarding the concerns on the cycle threshold, stating, “all laboratories should determine the threshold for a positive result at the limit of detection.”
As we approach Winter around the world, and colder temperatures, the public is being told that a Dark Winter is waiting, with governments and media predicting a rise in cases and deaths. However, it’s important that we pause to acknowledge the many concerns surrounding the PCR test before international health authorities crash the economy, send millions into poverty, and threaten civil liberties. We must help the public understand the limitations of the PCR test and the dangers of resting public health policy on such a flawed process.